BRC CP3 Checklist

Global Standard for Consumer Products Issue 3: February 2010
Audit Report Scorecard

Auditors should select yes or no for each question. Some questions also allow for a Not Applicable (N/A) answer. No questions shall be left
blank. Additionally auditors shall write a summary of findings for all fundamental clauses
For each clause, the auditor shall summarise the detail of all non conformities found and indicate whether they are Critical (C) , Major (M) or Minor (Min)
There is a space at the end of each section to allow auditor to include comments if they wish to do so. Auditors shall not write observations unrelated to the
Standard or any recommendations in this space but may record aspects audited but not covered by the questions relating to the section
Section
1
Senior Management Commitment and Continual Improvement
Fundament
al
The company's senior management shall demonstrate that they are fully committed to the implementation of the
Claus
e
requirements of the Global Standard for Consumer Products (referred to as The Standard). This shall include
provision of adequate resources, effective communication, systems of review, and actions taken to identify and
effect opportunities for improvement.
Summary
of
audit
or
findin
gs
Clause
Pro
d
Gro
up
1.1 All The companys senior management shall ensure
Non conformity
details
that product safety and quality objectives
are
established, documented, monitored, and
reviewed at least annually.
1.1 a All Are product safety and quality objectives Yes No
established, documented, and
monitored?
1.1 b All Are product safety and quality objectives Yes No
reviewed by senior management at least
annually?
Cert Body name and address
here
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!"is report s"all not be reproduced in part #it"out t"e permission of #$ert %ody name&
1.2
A
l
l The senior management review process shall be
Non conformity
details
documented and shall include an evaluation of:
Internal, customer, and external (third party)
audits; previous management review documents,
corrective action plans, and timeframes;
customer performance indicators,
complaints,
and feedback; incidents, non-conforming
materials and corrective actions; an assessment
of process performance; a review of the product
risk assessment system; a review of the results
of monitoring and testing; developments in legal
requirements or scientific information associated
with the products in scope; resource
requirements.
1.2 a
A
l
l
Is the senior management review
process Yes
N
o
documented, and does it include an
evaluation of internal, customer, and external
(third party) audits?
1.2 b A
l
Are previous management review documents, Yes N
o
l
corrective action plans, and timeframes
available and documented?
1.2 c
A
l
l Are customer performance indicators, Yes
N
o
complaints, and feedback reviewed and
documented?
1.2 d
A
l
l Are incidents, non-conforming materials, and Yes
N
o
corrective actions reviewed and
documented?
1.2 e
A
l
l
Is an assessment of process
performance Yes
N
o
conducted, reviewed, and documented?
1.2 f
A
l
l Is there review and documentation of the Yes
N
o
product risk assessment system?
1.2 g
A
l
l Is there review and documentation of the Yes
N
o
results of monitoring and testing?
1.2 h
A
l
l Is there review and documentation of Yes
N
o
developments in legal requirements or
here
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scientific information associated with the
products in scope?
1.2 i
A
l
l Is there review and documentation of Yes
N
o
resource requirements?
1.3
A
l
l The decisions and actions agreed shall be
Non conformity
details
effectively communicated to appropriate staff and
the actions implemented within the agreed
timescales. Records should be updated to show
when actions have been completed.
1.3 a
A
l
l Are agreed decisions and actions effectively Yes
N
o
communicated to appropriate staff?
1.3 b
A
l
l
Are actions implemented within the
agreed Yes
N
o
timescales?
1.3 c
A
l
l
Are records updated to show when
actions Yes
N
o
have been completed?
1.4
A
l
l The company's senior management shall provide
Non conformity
details
the human and financial resources required
to
implement and improve the processes of the
quality management system, the product risk
assessment plan, and to address legal, product
safety, and product quality matters.
1.4 a
A
l
l Has the company's senior management Yes
N
o
provided adequate human and financial
resources to implement and improve the
processes of the quality management
syste
m?
1.4 b
A
l
N
o
resources to implement and improve the
product risk assessment plan?
1.4 c
A
l
N
o
resources to address legal, product
safety,
and product quality matters?
here
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1.5 All There shall be clear communication and regular Non conformity details
reporting of the functioning of, and compliance
with, the Standard to senior management by the
staff responsible. This shall include suggestions
for improvement.
1.5 a All Is there clear communication and regular Yes No
reporting of the functioning of, and
compliance with, the Standard to senior
management by the responsible staff,
including suggestions for improvement?
1.6 All The company shall have a current, original copy Non conformity details
of the Standard available on site.
1.6 a All Does the company have a current, original Yes No
copy of the Standard available on site?
1.7
1 &
2 Where required by legislation, the site shall be Non conformity details
registered with or approved by the appropriate
government agency and evidence of this shall be
available.
1.7 a
1 &
2 Where required by legislation, is the site Yes No N/A
registered with or approved by the
appropriate government agency and is
evidence of this available?
Auditor remarks
Cert Body name and address here
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Section
2
Risk Management
Fundament
al he company shall have a management process in place to assure product safety, legality and quality, based on
Claus
e risk assessment principles. Sites must be aware of and refer to up-to-date legislation, product standards, codes of
practice, and developments in science or technology that may impact risk concerning their products and
packaging where these exist in the regions of intended sale.
Audit
or
findin
gs
Claus
e
Pr
od
Audit
Questions
Group
2.1 Product Scope and group determination
2.1.1 All The company shall identify the range of products Non conformity details
it wishes to include in the scope of certification
and the countries/states or regions for which the
products are to be made available for sale.
2.1.1
a
Al
l Has the company identified the range of Yes No
products it wishes to include in the scope of
certification and the countries/states or
regions for which the products are to be made
available for sale?
2.1.1
b
Al
l Is there evidence that the company is Yes No
manufacturing products that are
contained
within the scope of the audit?
2.1.2 All The company shall establish and document the Non conformity details
product group(s) assigned to the products in
scope, derived from application of the questions
indicated in the decision tree (see The Standard
Section II, 3.4).
here
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2.1.2
a
A
l
l Has the company established and Yes No
documented the product groups assigned to
the products in scope, derived from
application of the questions indicated in the
decision tree?
2.2 Legislative and safety requirements
2.2.1
A
l
l The company shall have and use a system, which Non conformity details
may comprise internal and/or external resources,
to demonstrate knowledge of all legislation,
product standards, product safety issues,
scientific and technical developments, and
industry/customer codes of practice in the regions
of intended sale relevant to the products in scope.
2.2.1
a
A
l
l
Does the company have and use a
system, Yes No
which may comprise both internal and
external resources, to demonstrate knowledge
of all legislation, product standards, product
safety issues, scientific and technical
developments, and industry/customer codes
of practice in the regions of intended sale
relevant to the products in scope?
2.2.2 A If the company relies on information concerning Non conformity details
l
l
product safety, quality, and legality provided by
their customer or related party, it shall validate the
information received and document the validation
proce
ss.
2.2.2
a
A
l
l Where the company relies on information Yes No N/A
concerning product safety, quality, and
legality provided by their customer or related
party, does it validate the information received
and document the validation process?
2.2.3
A
l
l A documented process shall exist for Non conformity details
incorporating changes in legislation, standards,
etc. into the companys procedures in a
timely
fashion, which shall be before any official
here
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implementation date of the relevant change.
2.2.3
a
A
l
l Does a documented process exist for Yes No
incorporating changes in legislation,
standards, etc. into the companys procedures
in a timely fashion?
2.2.4
A
l
l Copies of applicable legislation, standards, codes Non conformity details
of practice, and similar
documents shall be
available to relevant staff.
2.2.4
a
A
l
l Are copies of applicable legislation, Yes No
standards, codes of practice, and similar
documents available to relevant staff?
2.3 Risk assessment - prior to production
2.3.1
A
l
l A design specification covering each product shall Non conformity details
be documented, dated, and authorized. This shall
include all relevant information. As a guide, this
may include the following, although this is not an
exhaustive list: composition, size, color; bills of
materials; assembly diagrams; primary packaging;
intended shelf life; warnings or instructions for
use; use, misuse, usage patterns; productions
volumes. Any changes to the product design shall
be documented and dated.
2.3.1
a
A
l
l Is there a documented design specification to Yes No
cover each product?
2.3.1
b
A
l
l Are design specifications and revisions to Yes No
specifications dated?
2.3.1
c
A
l
l Do design specifications include all relevant Yes No
information?
2.3.2
A
l
l The company shall determined and list the legal Non conformity details
statutes and mandatory standards applicable to
each product and to the materials from which it is
made, relevant in the regions of intended sale.
here
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2.3.2 a
A
l
l Has the company determined and documented Yes No
the legal statutes and mandatory standards
applicable to each product and to the
materials from which it is made, relevant in the
regions of intended sale?
2.3.3
A
l
l The company shall ensure that a product hazard Non conformity details
and risk assessment is available and clearly
identifies: the hazards, the risk level for
each
hazard and whether the risk is acceptable;
the
person responsible for the assessment; the date
performed and the evidence (for example, sample
drawings, computer graphics) from which
the
assessment was derived. This risk assessment
may be provided by internal or external resources.
If the product requires modification, a new
risk
assessment shall be completed on the modified
desig
n.
2.3.3 a
A
l
l Is a product hazard and risk assessment Yes No
available that clearly identifies the hazards,
the risk level for each hazard and whether the
risk is acceptable?
2.3.3 b
A
l
l Is the person responsible for the assessment Yes No
clearly identified?
2.3.3 c
A
l
l Is the date on which the assessment was Yes No
performed and the evidence on which it
is
based identified?
2.3.3 d
A
l
l If the product requires modification, is a Yes No N/A
product hazard and risk assessment available
that clearly identifies where products
have
been modified, and is a new risk assessment
available?
2.3.4
A
l
l No products deemed to present an unacceptable Non conformity details
risk by the assessment described in clause 2.3.3
shall be produced.
here
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2.3.4
a All The audit does not result in evidence that Yes No
product has been produced that had
been
identified as being of an unacceptable
risk
during the risk assessment process?
2.4 Verification of the Product Risk Assessment
2.4.1 All The company shall ensure that risk assessments Non conformity details
have been carried out by competent staff (internal
or external) and shall document the way in which
this is assessed.
2.4.1
a All Does the company ensure that risk Yes No
assessment is carried out by competent staff
(internal or external), and do they document
the way in which this is assessed?
2.4.2 All
The risk assessment shall be regularly, and
at Non conformity details
least annually, reviewed (while the products are
still in production) to ensure that the assessment
remains up to date, takes account of complaints
or incidents with the product or similar products,
and reflects any changes in legislation.
2.4.2
a All While the products are in production, is there Yes No
a regular review of the risk assessment,
at
least annually?
2.4.2
b All Does the review ensure that the assessment Yes No
remains up to date, takes account of
complaints or incidents with the product or
similar products, and reflects any changes in
legislation?
2.4.3
1 &
2 The risk assessment shall be carried out before Non conformity details
production begins, and completion shall be
verified by a designated responsible person. If
customer sign-off is part of the contract of sale,
this shall be obtained.
2.4.3
a
1 &
2 Are risk assessments carried out before Yes No N/A
production begins, and is completion verified
by a designated responsible person?
here
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2.4.3 b
1 &
2 If customer sign off is part of the contract of Yes No N/A
sale, is this obtained?
2.4.4
1 &
2 Where there is legal requirement to do so or when Non conformity details
it is necessary to confirm its safety or legality, a
representative product should be submitted for
testing to a suitably qualified and accredited
laboratory (internal or external). The results of the
test should form part of the risk assessment.
2.4.4 a
1 &
2 Where product testing is required, either Yes No N/A
legally or on safety or quality grounds,
are
products submitted to a suitably qualified and
accredited laboratory (internal or external)?
2.4.4 b
1 &
2 Do the results of the test form part of the risk Yes No N/A
assessment?
2.4.5
1 &
2 Aspects of the product design/materials that are Non conformity details
critical to safety and which must be maintained in
production shall be established with the risk
assessment provider and the control limits set on
these features or materials.
2.4.5 a
1 &
2 Are all aspects of the product design/materials Yes No N/A
maintained in production that are critical to
safety established with the risk assessment
provider?
2.4.5 b
1 &
2 Are control limits set on these features or Yes No N/A
materials?
2.4.6
1 &
2 Where legally required, the identity, qualifications, Non conformity details
and/or license of the person producing the safety
review or risk assessment shall be documented
and verified.
2.4.6 a
1 &
2 Where legally required, is the identity, Yes No N/A
qualifications, and/or license of the
person
producing the safety review or risk
assessment documented and verified?
here
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Section 3
Management System
Clause Prod
Audit
Questions
Group
3.1
Policy statement
All The policy shall state the company's intention to Non conformity details
produce safe and legal products to the specified
3.1.1 quality (and to meet its responsibility to its
customers). This shall include the commitment for
review and continual improvement.
All Has the company's senior management Yes No
3.1.1 a developed, documented, and implemented a
policy statement?
3.1.1 b
All Is the policy statement authorized, regularly Yes No
reviewed, signed, and dated?
All Does the policy state the company's intention Yes No
3.1.1 c
to produce safe and legal products to the
specified quality and to meet its responsibility
to its customers?
3.1.1 d
All Does the policy include the commitment for Yes No
review and continual improvement?
All The company's senior management shall ensure Non conformity details
3.1.2
the policy statement is communicated to and
understood by all staff involved with activities
relating to product safety, legality, and quality.
All Is the policy statement communicated to and Yes No
3.1.2 a understood by all staff involved with activities
relating to product safety, legality, and quality?
3.2 General Documentation requirement
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3.2.1
Documentation Control
Statement
of The company's senior management shall Non conformity details
Inte
nt ensure that all documents records, and data
critical to the management of product safety,
legality and quality are in place and effectively
controlled.
3.2.1.1
A
l
l All documents in use shall be the current versions, Non conformity details
authorized and dated, and a procedure shall be in
place to ensure that obsolete documentation is
removed from use.
3.2.1.1
A
l
l Is there a procedure in place that defines how Yes No
a documentation is controlled?
3.2.1.1
A
l
l Is there a "Master List" of controlled Yes No
b
documents or another means of
identifying
which documents are controlled?
3.2.1.1
A
l
l Are documents in use the current version and Yes No
c are they authorized and dated?
3.2.1.1
A
l
l Is there a procedure in place to ensure obsolete Yes No
d documentation is removed from use?
3.2.1.2
A
l
l Documents shall be clearly legible, unambiguous, Non conformity details
in appropriate languages, and sufficiently detailed
to enable their correct application by staff. They
shall be readily accessible to relevant staff at all
times.
3.2.1.2
A
l
l Are documents clearly legible, unambiguous, in Yes No
a appropriate languages, and sufficiently detailed
to enable their correct application by
staff?
3.2.1.2
A
l
l
Is the documentation readily accessible
by Yes No
b relevant staff at all times?
3.2.1.3
A
l
l Changes or amendments to documents shall be Non conformity details
authorized and dated and the reason for the
change recorded.
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3.2.1.3
A
l
l Are all changes or amendments to documents Yes No
a authorized and dated and is the reason for the
change recorded?
3.2.1.3
A
l
l Are the most recent customer provided Yes No N/A
b
specifications available to the
appropriate
personnel, and being utilized by
manufacturing?
3.2.1.3
A
l
l Are drawings and manufacturing documents Yes No
c
updated when product changes are
made?
3.2.2 Record Completion and Maintenance
3.2.2.1
A
l
l The records shall be legible, genuine, appropriately Non conformity details
authorized, and retained in good condition for a
period which takes account of the product lifetime
and is consistent with the legal requirements in the
country of manufacture or sale. Customer-specific
requirements relevant to record retention shall be
respected.
3.2.2.1
A
l
l Does the company maintain records to Yes No
a demonstrate the effective control and
achievement of product safety, legality, and
qualit
y?
3.2.2.1
A
l
l Are receiving inspection records, inline Yes No
b inspection records, final inspection records
and nonconforming material records
which
show date of inspection, item number,
item
description, lot size, AQL and inspection
results maintained?
3.2.2.1
A
l
l Are the quality records available sufficient to Yes No
c verify conformity to specifications, operating
procedures, and evidence for problem solving?
3.2.2.1
A
l
l Are these records legible, genuine, Yes No
d appropriately authorized, and retained in good
condition for a period of time which takes into
account product lifetime, customer
requirements, and the legal requirements in the
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country of manufacture or sale?
3.2.2.2
A
l
l The company's senior management shall ensure Non conformity details
that procedures are operated for the
collation,
review, maintenance, storage, and retrieval of all
records relating to product safety, legality,
and
quality
.
3.2.2.2
A
l
l Does the company's senior management Yes No
a ensure that procedures are operated for the
collation, review, maintenance, storage, and
retrieval of all records relating to product
safety, legality, and quality?
3.2.2.3
A
l
l
Any alterations to records shall be visible
and Non conformity details
authorized, and the justification for alterations shall
be recorded.
3.2.2.3
A
l
l Are alterations to records visible and Yes No
a authorized, and is a justification for alterations
recorded?
3.2.3 Specification & Technical information dossiers
Statement
of The company shall ensure that specifications Non conformity details
Inte
nt exist for raw materials, components, and
bought-in components including packaging,
intermediate/semi-processed, and
finished
products and any product or service that could
affect the integrity of the finished product. A
technical folder shall be established for each
produ
ct.
3.2.3.1
A
l
l Specifications shall be adequate and accurate, and Non conformity details
shall ensure compliance with relevant safety,
legislative, and customer requirements. They shall
be accessible to relevant staff.
3.2.3.1
A
l
l Do adequate and accurate specifications exist Yes No
a
to ensure compliance with relevant
safety,
here
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legislative, and customer requirements?
3.2.3.1 All Are the specifications accessible to relevant Yes No
b staff?
3.2.3.2 All Companies shall maintain a technical folder Non conformity details
containing all relevant data (or details of where
such data is located) to ensure that products meet
the requirements of the Standard. For example:
detailed product specification (see clause 2.3.1);
bill of materials; safety data sheets on all chemicals
used where relevant to the safety, legality,
or
quality of the product; risk assessment(s);
description of the conformity assessment
procedure; test reports, inspection reports; list of
the legislation, product standards with which the
products are manufactured to comply; production
control procedures and charts; approvals by any
government body (if applicable); declarations of
conformity to legal requirements (if applicable).
3.2.3.2 All Does the company maintain a technical folder Yes No
a for each product containing relevant data to
ensure the products meet the requirements of
the standards?
3.2.3.3
1 &
2
The company shall seek formal agreement
of Non conformity details
specifications with relevant parties. Where
specifications are not formally agreed, then the
company shall be able to demonstrate that they
have taken steps to seek formal agreement.
3.2.3.3
1 &
2 Does the company seek formal agreement of Yes No N/A
a specifications with relevant parties?
3.2.3.3
1 &
2 Where specifications are not formally agreed, Yes No N/A
b can the company demonstrate that they have
taken steps to seek formal agreement?
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3.2.3.4
1 &
2 There shall be a documented procedure for the Non conformity details
amendment and approval of specifications for all
parts of the process including regular reviews to
ensure adequacy and status.
3.2.3.4
1 &
2 Is there a documented procedure for the Yes No N/A
a amendment and approval of specifications for
all parts and materials of the process including
regular reviews to ensure adequacy and
statu
s?
3.3
Organizational structure, responsibility, and management
authority
Statement of The company shall have a clearly defined and Non conformity details
Intent documented organizational structure that
ensures the awareness of job function,
responsibilities, and reporting relationships of
key staff.
3.3.1 All
The company shall have an organization
chart Non conformity details
demonstrating the structure of the company.
3.3.1 a All Does the company have an organization chart Yes No
demonstrating the structure of the company?
3.3.2 All Documented, clearly defined responsibilities shall Non conformity details
exist and be communicated to key staff with
responsibility for product safety, legality, product
quality, and management systems.
3.3.2 a All Do documented, clearly defined responsibilities Yes No
exist for key staff with responsibility for
product safety, legality, product quality, and
management systems?
3.3.2 b All Have these responsibilities been clearly Yes No
communicated to the appropriate staff?
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3.3.3
A
l
l A named individual with relevant experience and Non conformity details
qualifications shall be responsible for the
management of the legal, quality, and safety
requirements laid out in this Standard. This
responsibility should not present a conflict of
interest with any other responsibilities.
3.3.3 a
A
l
l Is there a named individual with relevant Yes No
experience and qualifications responsible for
the management of the legal, quality, and safety
requirements laid out in this Standard?
3.3.3 b
A
l
l Is it verified that there is no a conflict of interest Yes No
in this person's responsibilities?
3.3.4
A
l
l There shall be appropriate documented Non conformity details
arrangements in place to cover for the absence of
key
staff.
3.3.4 a
A
l
l Are there appropriate documented Yes No
arrangements in place to cover for the absence
of key staff?
3.3.5
A
l
l The company's senior management shall ensure Non conformity details
that a description of general duties or work
instructions is in place and communicated to all
staff involved with activities relating to
product
safety, legality, and quality.
3.3.5 a A
l
Has the company's senior management Yes No
l
ensured a description of general duties or work
instructions and communicated to all
staff
involved with activities relating to
product
safety, legality, and quality?
3.4
Internal Audit
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Statement
of The company shall audit the management
Non conformity
details
Inte
nt system to ensure that it is complied with and
appropriate.
3.4.1
A
l
l Internal audits shall cover all aspects associated
Non conformity
details
with the Standard. They shall be scheduled and
their scope and frequency shall be
established
commensurate with the risks associated with the
activity. Audits of aspects that directly affect
safety, legality, or quality shall be conducted at
least annually. Exceptions resulting in audit
intervals of more than one year shall be justified by
documented risk assessment.
3.4.1 a
A
l
l Does the company have internal audits that Yes No
cover all aspects associated with the Standard?
3.4.1 b
A
l
l Are the internal audits scheduled and is their Yes No
scope and frequency commensurate with the
risks associated with the activity?
3.4.1 c
A
l
l Are audits of aspects that directly affect safety, Yes No
legality, or quality conducted at least annually,
and if greater than annually is it justified by
documented risk assessment?
3.4.2
A
l
l Internal audits shall be carried out by competent
Non conformity
details
auditors, who shall be independent of the area of
operation being assessed. Auditors shall not audit
their own work.
3.4.2 a
A
l
l Are internal audits carried out by competent Yes No
auditors who are independent of the area of
operation being assessed?
3.4.3
A
l
l Corrective actions shall be formally agreed by the
Non conformity
details
person responsible for the action and implemented
within appropriate and agreed timescales.
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3.4.3 a
A
l
l
Are corrective actions formally assigned
to Yes No
persons responsible for the action and
implementation within appropriate and agreed
timescales?
3.4.4
A
l
l A record of all programmed internal audits and
Non conformity
details
associated corrective actions shall be maintained
with both conformity and nonconformity with the
requirements documented. All corrective actions
shall be verified to ensure satisfactory completion.
3.4.4 a
A
l
l Is a record of all programmed internal audits Yes No
and associated corrective actions maintained?
3.4.4 b
A
l
l Do these records list both conformity and Yes No
nonconformity with requirements documented?
3.4.4 c
A
l
l
Are all corrective actions verified to
ensure Yes No
satisfactory completion?
3.5 Purchasing, Supplier Approval and performance Review
Statement
of The company shall control all purchasing
Non conformity
details
Inte
nt processes which are critical to product safety,
legality, and quality to ensure that procured
products and services conform to
defined
requirements. In this context suppliers shall
include subcontractors and home
workers.
3.5.1
A
l
l The site shall have a documented supplier-
Non conformity
details
approval procedure, including a list of approved
suppliers for products, materials, and
services
impacting product safety, legality, or quality.
Procedures shall be established which
include
clear criteria for ongoing assessment and
the
standards of performance required.
Ongoing
assessment may take the form of monitoring
performance through one or more of the following,
although there may be other acceptable methods:
in-house checks; certificates of analysis; certificate
of conformity; supplier audits; traceability checks.
CP3 Issue:1
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Records of this monitoring shall be retained for at
least the lifetime of the product.
3.5.1 a
A
l
l Does the company have a documented supplier Yes No
approval procedure, including a list of
approved suppliers for products, materials and
services impacting product safety, legality, or
qualit
y?
3.5.1 b
A
l
l Does the supplier approval procedure include Yes No
clear criteria for ongoing assessment and the
standards of performance required?
3.5.1 c
A
l
l
Are supplier approval records kept for
the Yes No
lifetime of the product?
3.5.1 d A
l
Does the company maintain a list of
critical
Yes No
l
materials?
3.5.2
A
l
l The company shall review the performance of new
Non conformity
details
suppliers against defined criteria within a specified
"trial" period and thereafter at a specified frequency
to decide the level of ongoing supplier performance
monitoring.
3.5.2 a
A
l
l Does the company review the performance of Yes No
new suppliers against defined criteria within a
specified 'trial' period and thereafter at a
specified frequency to decide the level of
ongoing supplier performance
monitoring?
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3.5.3
A
l
l The procedure shall identify whether the use of
Non conformity
details
unapproved suppliers is acceptable under
any
emergency or unusual situations. If this is
the
case, the procedure shall define how exceptions
are recorded and how they are handled to maintain
safety, legality, and quality of the products.
3.5.3 a
A
l
l Is there a procedure for the use of suppliers, Yes No
not on the approved list, under any emergency
or unusual situations?
3.5.3 b
A
l
l Does the procedure define how exceptions are Yes No
recorded and how they are handled to maintain
safety, legality, and quality of the products?
3.6 Customer supplied property
Statement
of
The company shall exercise care
customer
Non conformity
details
Inte
nt property (including intellectual property) while
it is under the company's control or is being
used by the company.
3.6.1
A
l
l
The company shall identify, verify, protect
and
Non conformity
details
safeguard customer property including software,
intellectual property, tooling, fixtures, test
equipment and products. If any customer property
is lost, damaged or otherwise found to be
unsuitable for use, this shall be reported to
the
customer and records maintained.
3.6.1 a
A
l
l Does the company identify, verify, protect and Yes No
safeguard customer property including
software, intellectual property, tooling, fixtures,
test equipment and products?
3.6.1 b
A
l
l If any customer property is lost, damaged or Yes No
otherwise found to be unsuitable for use, is this
reported to the customer and records
maintained?
3.7 Corrective and Preventive Action
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Fundamental The company's senior management shall
Non conformity
details
Clause ensure that procedures exist to record,
investigate, analyze, and correct the cause of
nonconforming products or failure to
meet
standards, specifications, and
procedures
which are critical to product safety, legality,
and quality.
Auditor findings
3.7.1 All The company shall operate an effective system for
Non conformity
details
the capture, recording, and timely investigation of
nonconformities or matters reported as possible
nonconformities critical to product safety, legality,
or quality.
3.7.1 a All Does the company operate an effective system Yes No
for the capture, recording, and timely
investigation of nonconformities or matters
reported as possible nonconformities critical to
product safety, legality, or quality?
3.7.2 All Customer complaints concerning actual or potential
Non conformity
details
product nonconformity shall be included in
the
syste
m.
3.7.2 a All Are customer complaints concerning actual or Yes No
potential product nonconformity included in the
syste
m?
3.7.2 b All Are inspection records used included in Yes No
determining use of corrective action?
3.7.2 c All Do adequate procedures exist to record, Yes No
investigate, analyze and correct the cause of
nonconforming products?
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3.7.3 All An appropriate staff member shall be identified and
Non conformity
details
allocated the responsibility and accountability for
each corrective action. This shall be documented.
3.7.3 a All Does documentation support that an Yes No
appropriate staff member was identified and
allocated the responsibility and accountability
for each corrective action?
3.7.4 All The company shall ensure that effective corrective
Non conformity
details
actions are taken to prevent recurrence of the
problem and shall monitor and record their
completion within an appropriate timescale.
3.7.4 a All Does the company ensure that effective Yes No
corrective actions are taken to prevent
recurrence of the problem and does it monitor
and record their completion within an
appropriate timescale?
3.7.4 b All Is the corrective action system closed loop? Yes No
3.7.5 All The company shall review its processes at least
Non conformity
details
annually, incorporate industry best practice, and
adopt preventative measures as they become
available.
3.7.5 a All Does the company review their processes at Yes No
least annually, incorporate industry best
practice, and adopt preventive measures as
they become available?
3.7.5 b All Are the results of preventative actions Yes No
monitored and analyzed by management?
3.8 Traceability
CP3 Issue:1 Page 2' of Report No: Auditor:
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Fundamental The company shall have a system to identify
Non conformity
details
Clause and trace product lots/batches including raw
materials, components, and packaging
materials and follow this from the source of the
incoming material through all stages of
processing to supply of the product to
the
primary customer, and vice versa, in a timely
manner. ( Materials identified as low risk to the
safety, legality, or quality of the final product may
be exempted from lot traceability)
Auditor findings
3.8.1 All Companies shall be able to identify the immediate
Non conformity
details
source of all raw materials, components,
and
packaging materials.
3.8.1 a All Is the source of all raw materials, components, Yes No
and packaging materials identifiable?
3.8.2 All The products that constitute a lot/batch shall be Non conformity
details
defined and documented. This shall include
products made by continuous production methods.
3.8.2 a All Are products that constitute a lot/batch defined Yes No
and documented, including products made by
continuous production methods?
3.8.3 All
Identification of lots/batches of raw
materials
Non conformity
details
including packaging, processing aids,
intermediate/semi-processed products, part-used
materials, finished products and materials pending
investigation, shall be adequate to ensure
traceability.
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3.8.3 a
A
l
l Is the identification of lots/batches of raw Yes No
materials including packaging, processing aids,
intermediate/semi-processed products, part-
used materials, finished products and materials
pending investigation, adequate to
ensure
traceability as necessary?
3.8.4
A
l
l Final products shall be suitably marked, at least on
Non conformity
details
their outer packaging, to allow adequate
identification and traceability.
3.8.4 a
A
l
l Are final products suitably marked, at least on Yes No
their outer packaging, to allow adequate
identification and traceability?
3.8.5
A
l
l
Traceability must, in all cases, be available
for
Non conformity
details
each lot/batch from source of raw material to
supply to the primary customer.
3.8.5 a
A
l
l Is traceability available for each lot/batch from Yes No
source of raw material to supply to the primary
customer?
3.8.6
A
l
l The traceability system shall be maintained when
Non conformity
details
rework or any reworking operation is performed.
3.8.6 a
A
l
l
Is the traceability system maintained
when Yes No
rework or any reworking operation is
performed?
3.8.7
A
l
l The company shall test the traceability system to
Non conformity
details
ensure traceability can be determined from raw-
material receipt to finished product and vice versa.
This shall occur at a predetermined frequency, at
least annually, and results shall be retained. The
time taken to complete the exercise shall be
measured and recorded.
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2010
3.8.7 a All Does the company test the traceability system Yes No
to ensure traceability can be determined from
raw material receipt to finished product and
vice versa?
3.8.7 b All Does this occur at a predetermined frequency, Yes No
at least annually, and are results retained?
3.8.7 c All Is the time taken to complete this exercise Yes No
measured and recorded?
3.8.8 All When the same component or raw material is
Non conformity
details
sourced from more than one supplier, the
traceability system shall ensure that the
lots/batches from each supplier can be identified if
the component/material is identified as critical to
safety, quality, or legality.
3.8.8 a All In the case that the same component or Yes No N/A
material is sourced from more than one
supplier, does the traceability system ensure
that the lots/batches from each supplier can be
identified if the component/material is identified
as critical to safety, quality, or legality?
3.8.9 All Changes in materials, processes, or components
Non conformity
details
shall be traceable if they could affect the safety,
quality, or legality of the product and formally
agreed by the customer if contractually required.
3.8.9 a All Are changes in materials, processes or Yes No
components traceable if they could affect the
safety, quality, or legality of the product?
3.8.9 b All Is there evidence that changes in materials, Yes No
processes or components that could affect
safety, quality, or legality are formally agreed to
by the customer?
portrait 26//1! "
3.8.10 All Subcontracted manufacture of products or
Non conformity
details
components (including homeworking) must
be
traceable to a level appropriate to the risk.
3.8.10 All Is subcontracted manufacture of products or Yes No N/A
a components (including homeworking) traceable
to a level appropriate to the risk?
3.8.11
1 &
2 The need for further traceability through the chain
Non conformity
details
should be established, based on the risk
assessment and any legal or specific customer
requirements.
3.8.11
1 &
2 Has the need for further traceability through the Yes No N/A
a chain been established, based on the risk
assessment and any legal or specific customer
requirements?
3.8.12
1 &
2 For continuous production processes, methods of
Non conformity
details
defining traceability levels must be documented
and based on the risk assessment.
3.8.12
1 &
2 For continuous production processes, are the Yes No N/A
a methods of defining traceability levels
documented and based on the risk
assessment?
3.9 Management of Product withdrawal and product recall
Statement of The company shall have a plan and system in
Non conformity
details
Intent place to effectively manage product withdrawal
and product recall procedures.
3.9.1 All The company shall have a product recall procedure
Non conformity
details
in place to effectively manage product withdrawals
and recalls. Procedures shall exist to ensure that
customers are notified immediately on issues of
significance to the customer or consumer in terms
of product safety, quality, or legality.
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3.9.1 a All Does the company have a product recall Yes No
procedure in place to effectively manage
product withdrawals and recalls?
3.9.1 b All Do procedures exist to ensure that customers Yes No
are notified immediately on issues of
significance to the customer or consumer in
terms of product safety, quality, or legality?
3.9.2 All The company shall have written agreements in
Non conformity
details
place with distributors and other parties in
the
supply chain where these are necessary to ensure
effective withdrawal/recall.
3.9.2 a All Does the company have written agreements in Yes No
place with distributors and other parties in the
supply chain where these are necessary
to
ensure effective withdrawal/recall?
3.9.3 All In the event of a product recall, the certification
Non conformity
details
body issuing the current certificate and the
appropriate enforcement authorities shall be
informed in a timely manner. The company shall be
aware of and adhere to any legal reporting
obligations in the countries of sale.
3.9.3 a All In the event of a product recall, is the Yes No
certification body issuing the current certificate
and the appropriate enforcement authorities
informed in a timely manner?
3.9.3 b All Did the company demonstrate awareness of Yes No
and adhere to any legal reporting obligations in
the countries of sale?
3.9.4 1 & 2 The product recall and withdrawal procedures shall
Non conformity
details
be documented and regularly tested, at
least
annually, in a way that ensures their
effective
operation. Results of the test shall include timings
of key activities and shall be retained.
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2010
3.9.4 a
1 &
2 Are the product recall and withdrawal Yes No
procedures documented and regularly tested,
at least annually, in a way that ensures their
effective operation?
3.9.4 b
1 &
2 Do results of the test include timings of key Yes No N/A
activities and are they retained?
3.9.5
1 &
2 The company's senior management shall ensure
Non conformity
details
that results of this test shall be used to implement
improvements as necessary?
3.9.5 a
1 &
2 Does the company's senior management Yes No N/A
ensure that results of this test are used to
implement improvements as necessary?
3.10 Management of incidents and business continuity
Statement
of The company shall have procedures in place to
Non conformity
details
Inte
nt identify methods of ensuring business
continuity in the case of incidents and/or
informing their customers when
incidents
occur
.
3.10.1 A The company shall provide written guidance to Non conformity
details
l
l
relevant staff regarding the type of event that would
constitute an incident or emergency situation that
impacts product safety, legality, or quality, and a
documented reporting procedure shall be in place
which shall include informing their customers in a
timely manner.
3.10.1
A
l
l Does the company provide written guidance to Yes No
a relevant staff regarding the type of event that
would constitute an incident or
emergency
situation?
3.10.1
A
l
l Does the company have a documented Yes No
b
reporting procedure in place that
includes
informing their customers in a timely manner?
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3.10.2
1 &
2 The company shall develop contingency planning
Non conformity
details
for business continuity in the event of major
incidents such as: disruption to key services - e.g.
water, energy, staff availability; events such as
flood, fire, or natural disaster; malicious
contamination or sabotage.
3.10.2
1 &
2 Has the company developed contingency Yes No N/A
a planning for business continuity in the event of
major incidents such as: disruption to
key
services, flood, fire, or natural disaster, or
malicious contamination or sabotage?
3.10.3
1 &
2 The procedures shall include as a minimum:
Non conformity
details
identification of key staff constituting the incident
management team and their key responsibilities;
an up-to-date list of key contacts, with details of
agencies providing advice and support.
3.10.3
1 &
2
Does the business continuity plans
include Yes No N/A
a identification of key staff and their
responsibilities?
3.10.3
1 &
2 Does the business continuity plans include an Yes No N/A
b up-to-date list of key contacts?
3.10.3
1 &
2
Does the business continuity plans
include Yes No N/A
c details of agencies providing advice and
support?
3.11 Contract review and customer focus
Statement of The company's senior management shall
Non conformity
details
Intent ensure that processes are in place to determine
any customer requirements and expectations
with regard to product safety and quality, and
ensure that these are fulfilled.
3.11.1 All
Customer requirements shall be
documented,
Non conformity
details
reviewed, and confirmed on a suitable
predetermined frequency. Any resulting changes
shall be documented and communicated to
relevant departments.
CP3
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2010
3.11.1 All Are customer requirements documented, Yes No
a reviewed, and confirmed on a suitable
predetermined frequency?
3.11.1 All Are resulting changes documented and Yes No
b communicated to relevant departments?
3.11.2 All In the case where customers have set particular
Non conformity
details
performance indicators to be monitored, these
requirements shall be communicated, adhered to,
and reviewed at least annually.
3.11.2 All In the case where customers have set particular Yes No N/A
a performance indicators to be monitored, are
these requirements communicated, adhered to,
and reviewed at least annually?
3.11.3
1 &
2 The company shall clearly identify those individuals
Non conformity
details
responsible for communication with customers and
shall have an effective system for communication.
3.11.3
1 &
2 Has the company identified those individuals Yes No N/A
a responsible for communication with
customers?
3.11.3
1 &
2 Is there an effective system for this Yes No N/A
b communication?
3.11.4
1 &
2 Performance indicators relating to customer
Non conformity
details
satisfaction shall be established and communicated
to relevant staff, and performance reviewed against
these targets.
3.11.4
1 &
2 Have performance indicators relating to Yes No N/A
a customer satisfaction been established and
communicated to relevant staff, and is
performance reviewed against these targets?
3.12 Complaint handling
portrait 26//1! "
Statement of The company shall operate an effective system
Non conformity
details
Intent for the capture, recording, and investigation of
product complaints.
3.12.1 All A system shall be in place to capture, record, and
Non conformity
details
investigate all complaints relating to product safety,
legality, and unusual or critical quality defects, and
the results of the investigation shall be recorded.
3.12.1 All Is there a system in place to capture, record, Yes No
a and investigate all complaints relating to
product safety, legality, and unusual or critical
quality defects?
3.12.1 All Are the results of the investigation recorded? Yes No
b
3.12.2 All Where complaints are investigated externally on
Non conformity
details
behalf of the company, the responsibilities of the
parties shall be defined and the process shall be
documented. Companies shall seek to obtain the
results of any investigations carried out by such
partie
s.
3.12.2 All Where complaints are investigated externally Yes No
a on behalf of the company, are the
responsibilities of the parties defined and are
all the processes documented?
3.12.3 All Actions appropriate to the seriousness and
Non conformity
details
frequency of the problems identified shall be
carried out promptly and effectively by trained staff.
3.12.3 All Are actions appropriate to the seriousness and Yes No
a frequency of the problems identified, carried
out promptly and effectively by trained staff?
3.12.4 1 & 2
Complaint data shall be analyzed and used
to
Non conformity
details
implement ongoing improvements to
product
safety, legality, and quality, and to avoid
recurrence. This analysis shall be made available
CP3
Issue:1
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2010
Audit Report
Scorecard
to relevant staff.
3.12.4 1 & 2 Is complaint data analyzed and used to Yes No N/A
a implement ongoing improvements to product
safety, legality, and quality, and to avoid
recurrence?
3.12.4 1 & 2 Is this complaint analysis data made available Yes No N/A
b to relevant staff?
Auditor
remarks
CP3 Issue:1 Page 3' of Report No: Auditor:
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Section 4
Site
Standards
Clause
Produc
t Audit Questions
Group
4.1 Location, Perimeter and Grounds
Statement of
Sites used for manufacturing, storage
or
Non conformity
details
Intent distribution shall be of suitable size, location,
construction and design to facilitate
maintenance, prevent contamination, and
enable the production of safe and legal
products.
4.1.1 All The site to be included in the audit shall be clearly
Non conformity
details
defined, and shall be located and maintained so
as to allow the production of safe and
legal
products.
4.1.1 a All Is the site to be included in the audit clearly Yes No
defined, and is it located and maintained so as
to allow the production of safe and
legal
products?
4.1.2 All Consideration shall be given to local activities and
Non conformity
details
the site environment, which may have an adverse
impact on product integrity. Measures adopted at
the site to protect the product from any potential
contaminants shall be regularly reviewed
to
ensure that they continue to be effective.
4.1.2 a All Has consideration been given to local Yes No
activities and the site environment
which
would have an adverse impact on finished
product integrity and where necessary, are
measures taken to prevent contamination?
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Issue:1 Page 3 of Report No:
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"
4.1.2
b All
Is there a regular review of the
measures Yes No
adopted to protect the site from any potential
contaminants?
4.1.3 All The external areas and surroundings shall be
Non conformity
details
maintained in good order.
4.1.3
a All
Are the external areas and
surroundings Yes No
maintained in good order?
4.1.4 All External traffic routes that are under site control
Non conformity
details
shall be maintained in good repair to avoid
contamination of the product.
4.1.4
a All Where there are external traffic routes under Yes No
site control, are they maintained in good repair
to avoid contamination of the product?
4.1.5 All There shall be no evidence of facility damage due
Non conformity
details
to inadequate drainage.
4.1.5
a All Is there no evidence of facility damage due to Yes No
inadequate drainage?
4.2 Internal Site: Factory layout, Product Flow and Segregation
Fundamental Premises and plant shall be suitably designed,
Non conformity
details
Clause constructed, and maintained so as to control
the risk of product contamination and
to
comply with all relevant legislation.
Auditor findings
4.2.1 All
The building shall be maintained to
minimize
Non conformity
details
potential for product contamination.
4.2.1
a All Is the building designed and constructed to Yes No
minimize potential for product contamination?
4.2.1
b All Is the building maintained to minimize Yes No
potential for product contamination?
CP3 Issue:1 Page (! of Report No:
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4.2.2
A
ll The machinery and equipment shall be positioned
Non conformity
details
to allow an efficient product flow from incoming to
outgoing and shall be arranged to minimize the
risk of product contamination and damage.
4.2.2 a A Does the placement of machinery and Yes No
ll
equipment allow an efficient product flow and
minimize the risk of product contamination,
loss of traceability and damage?
4.2.3
A
ll A process flow diagram shall be available.
Non conformity
details
4.2.3 a
A
ll Is a process flow diagram available? Yes No
4.2.4
A
ll Premises shall allow sufficient working space and
Non conformity
details
storage capacity to enable all operations to be
carried out under safe and, if necessary, hygienic
conditions.
4.2.4 a
A
ll
Do the premises allow sufficient
working Yes No
space and storage capacity to enable
all
operations to be carried out under safe and if
necessary hygienic conditions,
including
areas such as raw material storage,
component storage, production floor, packing
or finishing area, finished product storage,
etc
?
4.2.5
A
ll There shall be effective segregation to minimize
Non conformity
details
the risk of product cross-contamination taking into
account the flow of product, nature of materials,
equipment, personnel, waste, airflow, air quality,
and utilities. When critical to product
safety,
legality, quality, or customer requirements,
controls shall be in place to ensure that
raw
materials, work in progress, rework, packaging,
and finished products of different specifications
are not inadvertently mixed.
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4.2.5
a All Is there effective segregation to minimize the Yes No
risk of product cross-contamination taking
into account the flow of product, nature of
materials, equipment, personnel,
waste,
airflow, air quality, and utilities?
4.2.5
b All Are controls in place to ensure that raw Yes No
materials, work in progress, rework,
packaging, and finished products of different
specifications are not inadvertently mixed?
4.2.6
1 &
2 The location of facilities and services, including
Non conformity
details
toilets, cleaning facilities, and catering facilities,
shall not jeopardize the integrity of the product.
4.2.6
a
1 &
2 Is the location of facilities and services, Yes No N/A
including toilets, cleaning and catering
facilities such that it does not jeopardize the
integrity of product?
4.3 Building interiors
Statement of The internal site, buildings, and facilities shall
Non conformity
details
Intent
be suitable for the intended purpose.
All
utilities to and within the production
and
storage areas shall be designed, constructed,
maintained, and monitored to
effectively
control the risk of product contamination.
4.3.1 All The quality and finish of site buildings and
Non conformity
details
facilities, including drainage when required, shall
be suitable for the intended purpose with due
regard to the risk of product safety, legality, and
quality, and shall be maintained to an appropriate
standard. This shall include: A clean, tidy and
clutter-free factory; adequate lighting; suitable and
sufficient removal of any by-products and
contaminants; impervious floors, in good repair,
and able to withstand cleaning
procedures.
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4.3.1 a
Al
l Is the quality and finish of site buildings and Yes No
facilities, including drainage, suitable for the
intended purpose with due regard to the risk
of product safety, legality, and quality and is it
maintained to an appropriate standard?
4.3.1 b
Al
l
Is there sufficient lighting in the
factory, Yes No
including the production floor, inspection
areas, test areas, storage areas, maintenance
areas, finishing and packing areas,
etc?
4.3.1 c
Al
l
Is the facility clean, tidy, and clutter
free, Yes No
including the production floor, inspection
areas, test areas, storage areas, maintenance
areas, finishing and packing areas,
etc?
4.3.2
1 &
2 Potential contamination risk from buildings and
Non conformity
details
overhead structures, including building voids,
shall
be controlled through regular documented
inspections, and corrective action shall be taken
to prevent the risk of production contamination.
4.3.2 a
1 &
2 Is potential contamination risk from buildings Yes No N/A
and overhead structures, including building
voids, controlled through regular documented
inspections?
4.3.2 b
1 &
2 Are corrective actions taken to prevent the Yes No N/A
risk of product contamination?
4.3.3
1 &
2
The site shall be assessed for any
particular
Non conformity
details
requirements relevant to the products
being
produced, such as temperature, humidity,
electrostatic discharge. Any identified
requirements shall be adopted, documented,
monitored, and regularly reviewed.
4.3.3 a
1 &
2 Has the site been assessed for any particular Yes No N/A
requirements relevant to the products being
produced, such as temperature, humidity,
electrostatic discharge?
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4.3.3 b
1 &
2
Are the identified requirements
adopted, Yes No N/A
documented, monitored and regularly
reviewed?
4.3.3 c
1 &
2 Is the ventilation adequate to maintain product Yes No N/A
safety, legality, and quality at the production
floor, inspection areas, test areas, storage
areas, maintenance areas, finishing
and
packing areas, etc.?
4.3.4 1 Walls, floors, ceilings, pipework, and overhead
Non conformity
details
structures shall be designed, constructed,
finished, and maintained to reduce condensation
and mold growth, and shall have access
to
facilitate cleaning.
4.3.4 a 1
Are walls, floors, ceilings, pipework,
and Yes No N/A
overhead structures designed, constructed,
finished, and maintained to reduce
condensation and mold growth, and are they
accessible to facilitate cleaning?
4.3.5 1 All water used as an ingredient of the products or
Non conformity
details
preparation of the products where it may come
into direct contact with the product shall
be
potable (as defined in the region of
intended
product sale), or suitably treated to
prevent
contamination, and shall be regularly monitored.
4.3.5 a 1 Is all water used as an ingredient of the Yes No N/A
products or preparation of the products where
it may come into direct contact with the
product potable (as defined in the region of
intended product sale), or suitably treated to
prevent contamination?
4.3.5 b 1 Is the water tested regularly? Yes No N/A
4.3.6 1 Water in the form of water, ice, or steam used for
Non conformity
details
cleaning or in connection with any operation in the
manufacture of products shall comply with legal
requirements in the country of use and present no
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risk to the safety, legality, or quality of the
products.
4.3.6
a 1
Does all water in the form of water, ice
or Yes No N/A
steam used for cleaning or in connection with
any operation in the manufacture of products
comply with legal requirements in the country
of use and present no risk to the safety,
legality, or quality of the products?
4.4 Staff Facilities
Statement of Staff facilities shall be sufficient to
Non conformity
details
Intent accommodate the required number of
personnel, and shall be designed and
operated to minimize the risk of
product
contamination. Such facilities shall be
maintained in good and clean
condition.
4.4.1 All Staff facilities such as washrooms, canteens, and
Non conformity
details
break areas shall be designed and operated so as
to minimize the risk of product contamination.
4.4.1
a All Are staff facilities such as washrooms, Yes No
canteens, and break areas designed
and
operated so as to minimize the risk of product
contamination?
4.4.2
1 &
2 Where smoking is allowed under national law,
Non conformity
details
designated controlled smoking areas shall be
isolated from production areas to an extent that
ensures smoke cannot reach the product.
Adequate arrangements for dealing with smokers'
waste shall be provided both internally
and
externally.
4.4.2
a
1 &
2 Are workers not allowed to have food, drink, Yes No N/A
or smoke at their work areas?
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4.4.2 b
1 &
2 Where smoking is allowed under national law, Yes No N/A
are designated controlled smoking
areas
isolated from production areas to an extent
that ensures smoke cannot reach the product?
4.4.2 c
1 &
2 Are adequate arrangements provided both Yes No N/A
internally and externally for dealing
with
smokers' waste?
4.4.3
1 &
2 Storage facilities of sufficient size to
Non conformity
details
accommodate all reasonable personal items shall
be provided for all personnel who work in areas
where they are unable to keep possessions with
the
m.
4.4.3 a
1 &
2 Are storage facilities of sufficient size Yes No N/A
available, to accommodate all
reasonable
personal items for all personnel who work in
areas where they are unable to keep
possessions with them?
4.4.4 1 Where specific workwear is required, designated
Non conformity
details
changing facilities shall be provided for all
personnel: staff, visitor, or contractor. These shall
be sited to allow direct access to the production,
packing, or storage areas without recourse to any
external area. Where this is not possible, a risk
assessment shall be carried out and procedures
implemented accordingly.
4.4.4 a 1
Where specific workwear is required,
are Yes No N/A
designated changing facilities provided for all
personnel such as staff, visitors, or
contractors?
4.4.4 b 1 Are the changing facilities located to allow Yes No N/A
direct access to the production, packing, or
storage areas without recourse to any external
are
a?
4.4.4 c 1 Where this is not possible, is a risk Yes No N/A
assessment carried out and procedures
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implemented accordingly?
4.4.5 1 Outdoor clothing and other personal items shall
Non conformity
details
be stored separately from workwear within the
changing facilities.
4.4.5
a 1 Are outdoor clothing and other personal items Yes No N/A
stored separately from workwear within the
changing facilities?
4.4.6 1 Suitable and sufficient hand-cleaning facilities
Non conformity
details
shall be provided at access to, and at
other
appropriate points within, production
areas.
Information on how to clean hands shall also be
provided near hand-cleaning points.
4.4.6
a 1
Are suitable and sufficient hand-
cleaning Yes No N/A
facilities provided at access to, and at other
appropriate points within, production areas?
4.4.6
b 1 Is information on how to clean hands provided Yes No N/A
near hand-cleaning points?
4.4.7 1 All food brought into manufacturing premises by
Non conformity
details
staff shall be stored in a clean and hygienic state.
No food shall be taken into storage, processing,
or
production areas.
4.4.7
a 1 Is all food brought into manufacturing Yes No N/A
premises by staff stored in a clean and
hygienic state?
4.4.7
b 1 Are storage, processing, and production areas Yes No N/A
free of any non-production food?
4.5 Cleaning procedures
Fundamental Housekeeping and cleaning systems shall be in place which ensure that Non conformity details
Clause adequate standards of cleanliness and tidiness are maintained at all times
and the risk of contamination is minimized.
Auditor findings
4.5.1
Al
l Cleaning practices shall be completed so as to
Non conformity
details
minimize risk of contamination.
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4.5.1 a
A
ll Are cleaning practices completed so as to Yes No
minimize risk of contamination?
4.5.2
A
ll
Cleaning and, where necessary,
disinfection
Non conformity
details
procedures shall be revalidated following building
or maintenance work, changes to equipment, or
introduction of new product types.
4.5.2 a
A
ll Are cleaning and, where necessary, Yes No
disinfection procedures revalidated following
building or maintenance work, changes to
equipment, or introduction of new product
type
s?
4.5.3
A
ll Cleaning, pest control, and process-aid chemicals
Non conformity
details
shall be suitably identified and controlled
to
prevent the risk of product contamination. They
must be clearly labeled and no chemicals shall be
decanted unless into properly labeled and
identified containers. Adequate storage facilities
shall be provided and sited so as not to
compromise the safety, legality, and quality of the
product.
4.5.3 a
A
ll Are cleaning, pest control, and process-aid Yes No
chemicals suitably identified and controlled to
prevent the risk of product contamination?
4.5.3 b
A
ll Are they clearly labeled and no chemicals Yes No
decanted unless into properly labeled and
identified containers?
4.5.3 c
A
ll Are adequate storage facilities provided and Yes No
sited so as not to compromise the
safety,
legality, and quality of the product?
4.5.4
A
ll If cleaning services are outsourced, the service
Non conformity
details
providers shall have signed a contract
which
identifies the scope and frequency of the work,
and a logbook shall be maintained as a record of
work done. A defined company representative
shall be responsible for ensuring that the work is
CP3 Issue:1 Page (' of Report No:
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carried out satisfactorily.
4.5.4 a
1 &
2 Where cleaning services are outsourced, do Yes No N/A
service providers have a signed
contract
which identifies the scope and frequency of
the work and a logbook maintained as a
record of work done?
4.5.4 b
1 &
2 Is a defined company representative Yes No N/A
responsible for ensuring that the work
is
carried out satisfactorily?
4.5.5
1 &
2 Documented cleaning procedures shall be in
Non conformity
details
place and maintained for the building, utilities,
plant, and all equipment. Cleaning procedures
shall included the following information as
a
minimum: responsibility for cleaning; item/area to
be cleaned; frequency of cleaning; method of
cleaning; cleaning materials to be used; cleaning
records and responsibility for verification.
4.5.5 a
1 &
2 Do documented cleaning procedures exist for Yes No N/A
the buildings, utilities, plant, and all
equipment?
4.5.5 b
1 &
2
Do the documented cleaning
procedures Yes No N/A
contain the following information as a
minimum: responsibility for cleaning, items or
area to be cleaned, frequency of cleaning,
method of cleaning, materials to be
used,
cleaning records and responsibility for
verification?
4.5.6
1 &
2 Cleaning and housekeeping shall be carried out
Non conformity
details
by trained personnel in accordance with
documented procedures, and records shall be
maintained.
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4.5.6
a
1 &
2 Is cleaning and housekeeping carried out by Yes No N/A
trained personnel in accordance with
documented procedures and records
maintained?
4.5.7 1 The effectiveness of cleaning and sanitation shall
Non conformity
details
be verified and documented. Corrective actions
shall be documented. Cleaning procedures shall
be revalidated following building work,
maintenance, changes to equipment or
new
product introduction.
4.5.7
a 1 Is the effectiveness of cleaning and sanitation Yes No N/A
verified and documented?
4.5.7
b 1 Are corrective actions documented? Yes No N/A
4.5.7
c 1 Are cleaning procedures revalidated following Yes No N/A
building work, maintenance, changes
to
equipment or new product
introduction?
4.6 Waste/Waste disposal
Statement
of
There shall be adequate systems for
the
Non conformity
details
Intent collection, collation, and disposal of waste
material.
4.6.1 All Systems shall be in place to prevent the
Non conformity
details
accumulation of waste in production areas, and to
prevent the use of unfit or defective materials.
4.6.1
a All Are systems in place to prevent the Yes No
accumulation of waste in production areas,
and to prevent the use of unfit or defective
materials?
4.6.2 All Waste shall be categorized according to
Non conformity
details
legislative requirements based on the intended
means of disposal, segregated if necessary, and
collected in suitably designated waste containers.
Where legally necessary, it shall be removed by
identified, licensed contractors, and records of
disposal shall be maintained by the company.
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4.6.2
a
A
ll Is waste categorized according to legislative Yes No
requirements based on the intended means of
disposal, segregated if necessary, and
collected in suitably designated waste
containers?
4.6.2
b
A
ll Where legally necessary, is waste removed by Yes No
identified, licensed contractors and records of
disposal maintained by the company?
4.6.3
A
ll Products which are to be disposed of on safety
Non conformity
details
grounds, as the result of a recall or withdrawal, or
as substandard trademarked materials, shall be
disposed of securely. This may be delegated to a
specialist in secure waste disposal. Records of
such material destruction or disposal shall be
maintained.
4.6.3
a
A
ll Are all products disposed of on safety Yes No
grounds, as the result of a recall or
withdrawal, or as substandard trademarked
materials, disposed of securely?
4.6.3
b
A
ll Are records of such material destruction or Yes No
disposal maintained?
4.6.4
A
ll Waste materials shall be suitably quarantined and
Non conformity
details
routed to ensure that they are not reintroduced
into nonwaste production flows.
4.6.4
a
A
ll Are waste materials suitably quarantined and Yes No
routed to ensure that they are not
reintroduced into nonwaste production flows?
4.6.5
A
ll External waste collection containers and
Non conformity
details
compactors shall be managed in such a manner
as to minimize risk to the product if necessary.
4.6.5
a
A
ll Are external waste collection containers and Yes No
compactors managed in such a manner as to
minimize risk to the product?
4.7 Pest control
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Statement of The company shall be responsible for
Non conformity
details
Inte
nt minimizing the risk of pest infestation on the
site
.
4.7.1
Al
l The company shall be responsible for identifying
Non conformity
details
and controlling the risk of pest infestation and
shall operate pest control procedures. If no pest
control is conducted the company shall have a full
justification for its absence, including its
customers acceptance. The justification shall be
reviewed at least annually. (NOTE: If there is a
justified absence of pest control then the other
clauses in this section are not applicable)
4.7.1 a
Al
l Has the company identified and controlled the Yes No
risk of pest infestation on the site, through
operation of pest control procedures?
4.7.1 b
Al
l
If no pest control is conducted, does
the Yes No
company have a full justification for its
absence, including their customers
acceptance?
4.7.1 c
Al
l If the company's explanation for lack of pest Yes No
control is justified, is this justification
reviewed at least annually?
4.7.2
Al
l The company shall either have a clearly defined
Non conformity
details
contract with external contractors which reflects
the activities of the site, or have trained staff.
4.7.2 a
Al
l
Does the company have a clearly
defined Yes No
contract with external contractors
which
reflect the activities of the site, or have trained
staff who undertake this responsibility?
4.7.3
Al
l Written procedures and inspection documentation
Non conformity
details
for pest control shall be maintained including a
logbook of work completed.
4.7.3 a
Al
l Are written procedures and inspection Yes No
documentation for pest control maintained?
Audit
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4.7.4
A
ll In the event of infestation, immediate action shall
Non conformity
details
be taken to eliminate the hazard and this shall be
documented. Action shall be taken to identify,
evaluate, and authorize the release of any product
potentially affected.
4.7.4 a
A
ll In the event of infestation, is immediate action Yes No
taken and documented to eliminate the
hazard?
4.7.4 b
A
ll Is the potentially affected product identified, Yes No
sorted, and segregated so that only
acceptable product is
released?
4.7.5
A
ll Full material safety data sheets (MSDS) for all
Non conformity
details
chemical pest control agents
used must be
available to relevant staff at all times and kept in a
designated place.
4.7.5 a
A
ll Are full material safety data sheets (MSDS) for Yes No
all chemical pest control agents used available
to relevant staff at all times and kept in a
designated place?
4.7.6
A
ll Bait stations shall be robustly constructed,
Non conformity
details
operational, and effective in killing the target
pests, and be positioned to avoid potential
contamination of materials and products.
4.7.6 a
A
ll Are bait stations robustly constructed, Yes No
operational, and effective in killing the target
pests and positioned to avoid potential
contamination of materials and products?
4.7.7
A
ll When necessary, materials or products shall be
Non conformity
details
fumigated, and records of this process shall be
kept. Fumigated goods may not be supplied to
customers without full professional safety
clearance and correct clearance documentation.
All fumigation operations shall be controlled by
staff with appropriate professional qualifications.
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r:
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4.7.7 a
A
ll Do records exist for any product or material Yes No
that has undergone fumigation?
4.7.7 b
A
ll Are fumigated goods verified by full Yes No
professional safety clearance with correct
clearance documentation?
4.7.7 c
A
ll Are all fumigation operations controlled by Yes No
staff with appropriate professional
qualifications?
4.7.8 1 Drains should be fitted with screens and traps to
Non conformity
details
prevent pest entry.
4.7.8 a 1 Are drains fitted with screens and traps to Yes No N/A
prevent pest entry?
4.7.9 1 Fly-killing devices and/or pheromone traps shall
Non conformity
details
be correctly sited and be operational. The design
and location of flying insect detectors, killers, and
traps used shall not cause contamination
of
products in production.
4.7.9 a 1 Are fly-killing devices and/or pheromone traps Yes No N/A
correctly sited and operational?
4.7.9 b 1 Does the design and location of flying insect Yes No N/A
detectors, killers, and traps used not cause
contamination of products in production?
4.7.10 1 Bait stations shall be tamper resistant.
Non conformity
details
4.7.10 1 Are the bait stations tamper resistant? Yes No N/A
a
4.8 Product transport, storage and distribution
Statement of All facilities used for the storage and
Non conformity
details
Inte
nt transportation of product, movement around
the site, and dispatch of finished product shall
be suitable for the purpose and maintained in
good repair.
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4.8.1
A
ll The company shall ensure that the transport and
Non conformity
details
storage of products is within its control,
from
delivery of raw materials and components
to
finished product. Dispatch shall be undertaken in
such a way as to prevent the risk of contamination
and damage.
4.8.1 a
A
ll Does the company have control of the Yes No
transport and storage of products, from
delivery of raw materials and components, to
finished product?
4.8.1 b
A
ll Is dispatch undertaken in such a way as to Yes No
prevent the risk of contamination and
damage?
4.8.2
A
ll Where storage is necessary, at any stage, all
Non conformity
details
items shall be securely protected from
contamination, deterioration, and damage.
4.8.2 a
A
ll Where storage is necessary, at any stage, are Yes No
items securely protected from contamination,
deterioration, and damage?
4.8.3
A
ll All transportation shall be in good repair and in a
Non conformity
details
clean/hygienic condition as necessary depending
on the product group.
4.8.3 a
A
ll Is transportation in good repair and in a Yes No
clean/hygienic condition as necessary
depending on the product group?
4.8.4
A
ll Where the product transported is susceptible to
Non conformity
details
weather damage, vehicles shall be loaded and
unloaded so as to protect the product.
4.8.4 a
A
ll Where the product transported is susceptible Yes No
to weather damage, are vehicles loaded and
unloaded so as to protect the product?
4.8.5
A
ll Where the product needs specific environmental
Non conformity
details
requirements to prevent degradation, the
appropriate conditions shall be
documented,
maintained, and monitored.
Audit
or:
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4.8.5
a
Al
l Where a product needs specific environmental Yes No
requirements to prevent degradation, are the
appropriate conditions documented,
maintained, and monitored?
4.8.6
Al
l When products are susceptible to hazards arising
Non conformity
details
from transport conditions or subject to transport
restrictions, the required conditions of transport
shall be documented, implemented, and subject
to
regular review. Any necessary product labeling
shall be documented and monitored.
4.8.6
a
Al
l When products are susceptible to hazards Yes No
arising from transport conditions or subject to
transport restrictions, are the required
conditions of transport documented,
implemented, and subject to regular review?
4.8.6
b
Al
l Is all necessary product labeling documented Yes No
and monitored?
4.8.7
Al
l Where the company employs third-party
Non conformity
details
contractors, there shall be an agreement between
the company and the contractor. All the
requirements specified in this section shall be
clearly defined in the contract.
4.8.7
a
Al
l
Where the company employs third-
party Yes No N/A
contractors, is there agreement between the
company and the contractor, with any
particular requirement clearly documented in
the contract?
4.9 Site Security
Statement
of Security shall be maintained to prevent access
Non conformity
details
Int
ent of unauthorized persons to production and
storage areas.
4.9.1
Al
l Access to the site by employees, contractors, and
Non conformity
details
visitors shall be controlled and a visitor-reporting
system shall be in place.
Audito
r:
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2010
4.9.1 a All Is there controlled access to the site by Yes No
employees, contractors, and visitors and a
visitor reporting system in place?
4.9.2 All Contractors involved in maintenance or repair
Non conformity
details
shall be qualified or supervised, and a nominated
staff member shall be responsible for their
activities with regard to potential effects on the
safety, legality, or quality of products.
4.9.2 a All Are contractors involved in maintenance or Yes No
repair qualified or supervised, with a
nominated staff member responsible for their
activities?
4.9.3 1 & 2 Staff shall be trained in site security procedures
Non conformity
details
and encouraged to question or report unidentified
or unknown visitors.
4.9.3 a 1 & 2 Are staff trained in site security procedures Yes No N/A
and encouraged to question or report
unidentified or unknown visitors?
Auditor
remark
s
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Section 5
Product
Control
Clause Prod
Group
5.1 Preproduction reference samples
Statement of Documented procedures shall be in place for
Non conformity
details
Intent the selection, handling, storage, approval, and
use of reference samples as well as for
component samples and samples of
subcontracted work where relevant.
5.1.1 All The company shall document a process to identify,
Non conformity
details
select, and categorize reference samples.
If
customers have a defined system of sealed
samples referring to different stages of sample
approval, the customer procedure shall be
documented and followed.
5.1.1 a All Is there a process to identify and select Yes No
reference samples?
5.1.1 b All Where customers have a defined system of Yes No
sealed samples referring to different stages of
sample approval, is this process documented
and followed?
5.1.2 All As a minimum, a sample of the product which has
Non conformity
details
been approved by the customer or, if customer
approval is not possible, a sample representative of
the agreed specification, shall be retained.
Procedures shall be in place to record the selection,
use, approval, and storage of reference and/or
component samples.
CP3
Issue:1
Page 5'
of Report No:
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5.1.2
a
A
l
l Are samples of products retained and Yes No
maintained?
5.1.2
b
A
l
l Are the retained samples either approved by the Yes No
customer or, if customer approval is not
possible, representative of the agreed
specification including retention time?
5.1.2
c
A
l
l Are procedures in place to record the selection, Yes No
use, approval and storage of reference and/or
component samples?
5.1.2.d
A
l
l Are approval samples reviewed prior to Yes No
production or at the pre-production meeting and
is this documented in meeting notes?
5.1.2
e
A
l
l
Does the factory's Quality Control
function Yes No
compare client approved samples to the
production units?
5.1.3
A
l
l Reference samples shall be held and stored in
Non conformity
details
suitable environmental conditions to maintain their
original status.
5.1.3
a
A
l
l Are reference samples held and stored in Yes No
suitable environmental conditions that
will
maintain their original status?
5.1.4
A
l
l A secure and tamper-evident system shall be in
Non conformity
details
place for the storage of samples.
Temporary
removal of samples must be documented
and
authorized by a designated responsible person.
5.1.4
a
A
l
l Is a secure and tamper evident system in place Yes No
for the storage of samples?
5.1.4
b
A
l
l Is temporary removal of samples documented Yes No
and authorized by a designated responsible
perso
n?
5.1.5
A
l
l Records shall be maintained of reference samples
Non conformity
details
supplied to other parties, including the date
supplied and details of the sample.
5.1.5
a
A
l
l Are records of reference samples supplied to Yes No
other parties maintained, which have the date
CP3 Issue:1
Page 5
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supplied and details of the sample?
5.1.6 All Exceptions to the need to store samples shall be
Non conformity
details
made when such storage is impractical, provided
that an alternate means of achieving the same
objective is documented, justified, and maintained.
5.1.6
a All If samples are not being stored, are there Yes No
alternate means of achieving the objective of
reference samples?
5.2 Chemical formulation control
Statement of
The chemical composition of products
and
Non conformity
details
Inte
nt chemicals used in the manufacture or
processing of products shall be
identified,
monitored, and recorded as required by
legislation in the country of sale and/or
manufacture. Where approvals for use need to
be obtained, these shall be in place.
5.2.1 All Where companies use materials or preparations for
Non conformity
details
which the supplier does not wish to divulge
confidential formulations, they must have a
procedure in place to ensure the safety and legality
of such materials (for example, through an
independent third-party review) and must assure
themselves that any information which may be
legally required will be made available to the
authorities in a timely fashion.
5.2.1
a All Are procedures in place to ensure the safety Yes No
and legality of materials when the supplier does
not wish to divulge confidential formulations?
5.2.2 All Companies shall review, document, and justify the
Non conformity
details
use of any substances classified as dangerous or of
very high concern in the country of sale.
5.2.2
a All
Does the company review, document,
and Yes No
justify the use of any substances classified as
dangerous or of very high concern in the
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country of sale?
5.2.3 All Written (and/or diagrammatic), authorized
Non conformity
details
procedures for the handling of chemicals shall be
available at the point of use.
5.2.3
a All Are written (and/or diagrammatic), authorized Yes No
procedures for the handling of chemicals
available at the point of use?
5.2.4
1 &
2 Companies shall identify and document the use of
Non conformity
details
any nanomaterials.
5.2.4
a
1 &
2 Has the company identified and documented Yes No N/A
the use of any nanomaterials?
5.3 Product packaging materials
Statement of Product packaging materials shall be suitable
Non conformity
details
Intent for the intended use and stored under
conditions to minimize the risk of contamination
and deterioration.
5.3.1 All Product packaging shall conform to an agreed and
Non conformity
details
documented specification and shall meet the legal
requirements of the regions of sale with regard to
composition, recyclability, and minimizing excessive
use of packaging material.
5.3.1
a All Does product packaging conform to agreed and Yes No
documented specifications?
5.3.1
b All
Does the product packaging meet the
legal Yes No
requirements of the regions of sale?
5.3.2 All Packaging shall be assessed for fitness for purpose
Non conformity
details
and found suitable with regard to: protecting the
product from damage; maintaining the integrity of
the product; protecting the consumer from injury;
preventing contamination.
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5.3.2
a All Has the packaging been assessed for fitness, Yes No
purpose, and determined suitable
for
maintaining product integrity and preventing
damage?
5.3.2
b All Has the packaging been assessed for protecting Yes No
the consumer from injury?
5.3.2
c All
Has the packaging been assessed
for Yes No
preventing product contamination?
5.3.3 All Packaging materials shall be effectively protected
Non conformity
details
before being returned to storage.
5.3.3 All Are packaging materials effectively protected Yes No
a
while out of storage?
5.3.4 All Where staples or other metal closures are used for
Non conformity
details
packaging, appropriate precautions shall be taken
to prevent the risk of contamination, damage, or
injury to the product or consumer.
5.3.4
a All Are appropriate precautions in place to prevent Yes No
the risk of contamination, damage or injury to
the product or consumer, when staples or metal
closures are used?
5.3.5
1 &
2 Where there is a risk of product contamination from
Non conformity
details
transit packaging that could compromise product
safety, legality, and quality, such packaging shall be
removed from production areas.
5.3.5
a
1 &
2 Is transit packaging managed or removed from Yes No N/A
production areas where it may pose a risk of
product contamination that could compromise
product safety, legality, and quality?
5.4 Control on nonconforming materials
Statement of The company shall ensure that nonconforming
Non conformity
details
Intent materials, components, and products are clearly
identified, labeled, quarantined, investigated,
and documented.
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5.4.1 All Clear procedures for the control of nonconforming
Non conformity
details
materials and products, including rejection,
segregation, acceptance by concession, or re-
grading for an alternate use, shall be in place and
understood by all authorized personnel.
5.4.1 All
Do procedures exist to identify and
control Yes No
a nonconforming materials and products
including rejection, segregation, acceptance by
concession or re-grading for an alternative use?
5.4.
1 All Are suspected nonconforming materials, Yes No
b components and products adequately identified
and segregated to prevent further use, moved
out of the normal process flow when possible,
and recorded for management review?
5.4.1 All If non-conforming materials, components or Yes No
c products are reworked, do records show they
have been re-inspected and approved for
releas
e?
5.4.2 All The company shall have a procedure in place for
Non conformity
details
the secure disposal of nonconforming products and
their packaging according to the nature of
the
problem and/or the specific requirements of the
customer and any legal requirements.
5.4.2 All Is there an acceptable procedure in place for the Yes No
a secure disposal of non conforming products
and their packaging?
5.5 Handling requirements for specific materials
Statement of Where materials or products require special
Non conformity
details
Intent handling procedures to be in place, these shall
be maintained to ensure product safety, quality,
and legality are not compromised.
5.5.1 All
Materials and products requiring
segregation
Non conformity
details
procedures (e.g., materials intended for different
geographical regions) shall have control procedures
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in place to ensure that product integrity is
maintained.
5.5.1 All Do procedures exist to maintain product Yes No
a integrity where materials or products
segregation is required?
5.5.2 1 & 2 The company shall determine whether allergenic or
Non conformity
details
sensitizing materials are used (or likely to
be
contaminants of materials used) and shall identify
any such materials used on site.
5.5.2 1 & 2 Do procedures exist for identifying allergenic or Yes No N/A
a sensitizing materials that are used in the
product, or may contaminate the product during
production?
5.5.3 1 & 2 Documented policies shall exist for the handling of
Non conformity
details
allergenic or sensitizing materials including:
physical or time segregation from other products;
use of identified, dedicated equipment if necessary;
adequate labeling of final products.
5.5.3 1 & 2 Do documented policies exist for the handling Yes No N/A
a of allergenic or sensitizing materials for
physical or time segregation from other
products?
b of allergenic or sensitizing materials for use of
identified, dedicated equipment if necessary?
c of allergenic or sensitizing materials for
adequate labeling of final products?
5.6 Stock Control and product release
Statement of The company shall ensure that the finished
Non conformity
details
Intent
product is not released unless all
agreed
procedures have been followed and the release
is suitably controlled.
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5.6.1 All A procedure shall be in place to ensure that only
Non conformity
details
products conforming to specification are
dispatched. If no such control is conducted, the
company shall have a full justification for its
absence, which shall be reviewed at least annually.
Procedures may include, but are not limited to:
positive final release by authorized staff; online test
methods; automatic rejection process (which must
be validated and monitored).
5.6.1 All Is there a procedure to ensure that only Yes No
a products conforming to specification are
dispatched?
5.6.1 All If a procedure does not exist, does the company Yes No
b
have a justification for its absence and is
it
reviewed annually by management?
5.6.2 All Companies shall ensure that work carried out by
Non conformity
details
homeworkers or subcontracted off-site shall be
included in procedures described in clause 5.6.1.
5.6.2 All Do procedures exist to manage and control Yes No
a work carried out by home-workers or
subcontractors?
5.6.3 1 & 2 Controls shall be in place to ensure correct stock
Non conformity
details
rotation and that materials and products are used in
the correct order and within the allocated shelf or
usage life if applicable.
5.6.3 1 & 2 Do procedures exist to ensure correct stock Yes No N/A
a rotation so that materials and products are used
in the correct order and within the allocated
shelf or usage life?
5.6.4 1 & 2 Procedures shall be in place for disposal of excess
Non conformity
details
stock or obsolete inventory where such situations
routinely occur. If such disposal is an
isolated
instance, measures taken shall be documented.
5.6.4 1 & 2 Do procedures exist for the disposal of excess Yes No N/A
a stock or obsolete inventory?
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5.6.4 1 & 2 When applicable, is there a procedure for the Yes No N/A
b disposal of products or materials as a result of
overruns, order cancellations and
nonconformance, per customer requirements?
Auditor
remarks
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Section 6 Product Conformity Assessment
Clause
Pro
d
Audit
Questions
Group
6.1 Product Analysis/Testing
Fundamental
A suitable, sufficient, and validated
testing Non conformity details
Clause regime shall be in place to ensure the safe, legal
production of products to the required
conformance of safety, legality, and quality.
Results from the program shall be recorded,
reviewed, and stored securely.
Auditor findings
6.1.1 All Companies shall adopt a product-testing program Non conformity details
based on information such as: the outcome of the
risk assessment procedure including any defined
control points; any legal requirements for testing in
the regions(s) of intended sale; customer
requirements regarding supply of test reports or
other information; their own requirements for
demonstrating the production of safe products;
information needed to confirm composition
of
materials; historical data on problems or
complaints. In cases where it is established that no
testing is required, this shall be justified,
documented, and reviewed at least annually. (Note:
If there is a justified absence of testing then the
other clauses in this section are not applicable.)
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6.1.1 a
A
l
l Is there a documented comprehensive product Yes No
testing program that has been developed to
ensure all testing requirements are met?
6.1.1 b
A
l
l In cases where it is established that no testing Yes No
is required, is this justified, documented and
reviewed at least annually?
6.1.2
A
l
l The company shall identify the different stages (for Non conformity details
example, preproduction, production) at
which
testing is to be performed.
6.1.2 a
A
l
l Has the company identified and documented Yes No
the different stages of production at
which
testing is required?
6.1.2 b
A
l
l Is there evidence that appropriate testing is Yes No
being performed at the identified production
stage
s?
6.1.3
A
l
l A documented sampling plan, testing program, and Non conformity details
test specification, including the pass or fail criteria,
shall be produced for each product or product type
as required.
Testing procedures carried out as a result of
a
complaint, product failure, or other ad hoc reason
shall be clearly documented.
6.1.3 a
A
l
l Is there a documented sampling plan, testing Yes No
program, and test specification?
6.1.3 b
A
l
l Does the sampling plan include the pass or fail Yes No
criteria for each product or product type as
required?
6.1.3 c
A
l
l If additional testing is initiated as a result of a Yes No
complaint, product failure, or other ad
hoc
reason, is it clearly documented?
6.1.4
A
l
l Testing shall be undertaken by the company, the Non conformity details
subcontractor, a competent third party, a laboratory
designated by government authorities, or
the
customers designated testing laboratories,
as
agree
d.
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6.1.4 a
A
l
l Is testing undertaken by agreed testing facilities Yes No
or organizations?
6.1.5
A
l
l For tests which are critical to product safety or Non conformity details
legality, the laboratory used shall have gained
recognized laboratory accreditation against ISO
17025 for the tests to be carried out. If accredited
facilities are not used, the laboratory conducting the
tests must be able to provide verifiable evidence
that it is complying with the requirements of ISO
1702
5.
6.1.5 a
A
l
l Where tests which are critical to product safety Yes No
or legality, is the
laboratory undertaking the
testing accredited against ISO 17025 for the
tests to be carried out?
6.1.5 b
A
l
l If not accredited is there verifiable evidence that Yes No
the testing was in compliance with ISO 17025?
6.1.6
A
l
l Procedures shall be in place to ensure the security Non conformity details
of samples and test results.
6.1.6 a
A
l
l Are procedures in place to ensure the security Yes No
of samples and test
results?
6.1.7
A
l
l Where testing is submitted to third parties, the Non conformity details
required testing shall be clearly defined including,
for example, reference to the number, date, and
version of the test standard or method to be used.
In cases where the company relies on the expertise
of third-party testing organizations to determine
appropriate test requirements, the company shall
ensure that the third party receives a clear written
briefing on the purpose of the test and that the
testing program is formally agreed and
documented.
6.1.7 a
A
l
l Are the methods and the test to be performed Yes No
clearly identified?
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6.1.7 b
A
l
l In cases where the company relies on the Yes No
expertise of third party testing organizations to
determine appropriate test requirements, does
the company ensure that the third party
receives a clear written briefing on the purpose
of the test prior to the testing being agreed?
6.1.8 A
l
For tests other than those specified in clause 6.1.5, Non conformity details
l
procedures shall be in place to ensure validity of all
test results: use of documented, validated
test
methods; use of correctly calibrated and maintained
test equipment; incorporation of quality control
checks in the tests; use of systems such as
proficiency testing to verify the accuracy of results
where available; use of suitably qualified and/or
trained staff, competent to carry out the analyses
requir
ed.
6.1.8 a
A
l
l Do procedures exist to ensure validity of all test Yes No
result
s?
6.1.8 b
A
l
l Are documented, validated test methods being Yes No
used?
6.1.8 c
A
l
l Is there evidence that test equipment being Yes No
used is correctly calibrated and maintained?
6.1.8 d
A
l
l Are quality control checks incorporated in the Yes No
tests if required?
6.1.8 e
A
l
l
Are systems such as proficiency testing
to Yes No
verify the accuracy of results being used where
available?
6.1.8 f
A
l
l Is there evidence that suitably qualified and/or Yes No
trained staff, competent to carry out the
analyses required are performing the work?
6.1.9
A
l
l Test results which are outside the defined Non conformity details
specification shall be reviewed in a timely manner
by the nominated person responsible for safety,
legality, and quality, and the need for corrective
action assessed, documented, and carried out as
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necessary.
6.1.9 a All Are test results outside the defined Yes No
specification reviewed and the need for
corrective action assessed, documented, and
actioned?
6.1.10 1 & 2 Where testing laboratories are present on a Non conformity details
manufacturing site, they shall be located, designed,
and operated to eliminate potential risks to product
safety. Controls shall be documented, implemented,
and shall include consideration of the following:
design and operation of drainage and ventilation
systems; access to and security of the
facility;
movement of laboratory personnel;
protective
clothing arrangements; processes for obtaining
product samples; disposal of laboratory waste.
6.1.10 a 1 & 2 Where testing laboratories are present on a Yes No
manufacturing site, are they located, designed,
and operated to eliminate potential risks
to
product safety?
6.1.10 b 1 & 2 Are controls documented and implemented to Yes No
include design and operation of drainage and
ventilation systems?
6.1.10 c 1 & 2 Are controls documented and implemented to Yes No
include access to and security of the facility?
6.1.10 d 1 & 2 Are controls documented and implemented to Yes No
include movement of laboratory personnel?
6.1.10 e 1 & 2 Are controls documented and implemented to Yes No
include protective clothing
arrangements?
6.1.10 f 1 & 2 Are controls documented and implemented to Yes No
include processes for obtaining product
samples?
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6.1.10 g
1 &
2 Are controls documented and implemented to Yes No
include disposal of laboratory waste?
6.2 Inspections
Statement of When product inspections are deemed Non conformity details
Inte
nt necessary to assure delivery of a safe, legal
product of the required quality, they should be
carried out following defined procedures that
are documented, reviewed, and authorized.
6.2.1 All
Companies shall assess the need for
product Non conformity details
inspections, which, if required, shall have a defined
purpose and operate to a defined list of parameters
to be examined, with defects and defect
types
clearly identified. In cases where it is established
that no inspections are necessary, this shall be
justified, documented, and reviewed at least
annually. (Note: If so, then the other clauses in this
section are not applicable.)
6.2.1 a All Has the company assessed the need for Yes No
product inspection?
6.2.1 b All Is there documented justification where Yes No
inspections are not necessary or feasible, and
is this reviewed at least annually?
6.2.1 c All Are the inspections defined by the assessment Yes No
referenced in 6.2.1 being conducted?
6.2.1 d All Are required inspections undertaken with a Yes No
defined purpose and operated to a defined list
of parameters to be examined, with defects and
defect types clearly identified? All results must
be documented
6.2.2 All Sampling procedures shall be defined, Non conformity details
documented, and justifiable. The appropriateness
must be demonstrable and based on considerations
of risk, type of product, inspection
frequency,
statistical rationale, etc.
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6.2.2 a
A
l
l Are sampling procedures or instructions Yes No
defined, documented and justifiable?
6.2.3
A
l
l Sampling plans, where required, shall be Non conformity details
documented and approved and reviewed when
changes in production methods or materials occur.
They shall include as a minimum: the sample size
to be taken; the acceptance/rejection
criteria;
defined acceptable quality limit (AQL); the defect
classification; the actions to be taken in the case of
rejecti
on.
6.2.3 a
A
l
l Are sampling plans documented, approved, and Yes No
reviewed when changes in production methods
or materials occur?
6.2.3 b
A
l
l Where applicable, are workmanship standards Yes No
available in the form of controlled written
standards, visual exhibits (color chips, photos,
etc.) and/or samples?
6.2.4
A
l
l Inspections shall be conducted at a level and/or Non conformity details
frequency to assure product quality is at an AQL
level that is acceptable to the customer.
6.2.4 a
A
l
l Are inspections conducted in accordance with Yes No
an AQL plan that is acceptable to the customer?
6.2.5
A
l
l
The company shall have a defined policy
and Non conformity details
procedure covering the handling of
inspected
goods; for example: policy on returning inspected
goods to production; repacking
requirements;
dispos
al.
6.2.5 a
A
l
l Is there a defined policy and procedure Yes No
covering the handling of inspected goods?
6.2.5 b
A
l
l Is there evidence that procedure is being Yes No
followed?
6.2.6
A
l
l Procedures shall be in place to ensure inspections Non conformity details
are carried out in suitable conditions and
with
sufficient space and lighting to avoid the
introduction of hazards into the products.
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6.2.6 a
A
l
l Are procedures in place to ensure inspections Yes No
are carried out in suitable conditions and with
sufficient space and lighting to avoid the
introduction of hazards into the
products?
6.2.6 b
A
l
l Is inspection equipment used sufficient to verify Yes No
product safety, quality and legality?
6.2.7
A
l
l Personnel undertaking inspections shall be suitably Non conformity details
qualified and/or trained, and shall be competent to
carry out the work required.
6.2.7 a
A
l
l Are personnel undertaking inspections suitably Yes No
qualified and/or trained, and competent to carry
out the inspection?
6.2.8
A
l
l When external contractors are used for inspections, Non conformity details
they shall be subjected to the usual
supplier/subcontractor approval processes.
6.2.8 a
A
l
l Are external contractors subject to the Yes No
supplier/subcontractor approval processes, per
section 3.5?
6.2.9 A Inspection results which are outside the defined Non conformity details
l
l
acceptance level shall be reviewed in a
timely
manner by a competent person and the need for
corrective action assessed, documented,
and
completed.
6.2.9 a
A
l
l
Are inspection results outside the
defined Yes No
acceptance level, reviewed in a timely manner
and the need for corrective action assessed,
documented, and completed as
required?
6.3 Product claims
Statement
of The company shall have procedures in place to Non conformity details
Inte
nt validate and declared product information or
claims made for the products and
monitor
compliance with such claims if
necessary.
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6.3.1 All Where necessary the company shall operate a Non conformity details
quantity control system which conforms to legal
requirements and/or specified customer
requirement in the region where the product
is
available for sale.
6.3.1 a All Where necessary, does the company operate a Yes No
quantity control system which conforms to legal
requirements and / or specified customer
requirement in the region where the product is
available for sale?
6.3.2 All Where quantity checking is required, the frequency Non conformity details
and methodology used shall meet the minimum
requirements of any legislation governing quantity
verification.
6.3.2 a All Where quantity checking is required, does the Yes No
frequency and methodology used meet the
minimum requirements of any legislation
governing quantity verification?
6.3.3 All Any claims about a product, e.g., a weight limit for a Non conformity details
trampoline or sun protection factor on a cream,
shall be fully validated to ensure that products meet
the stated claim.
6.3.3 a All Do documents exist to validate product Yes No
performance claims and attributes?
6.3.4 1 & 2
The company shall undertake product-in-
use Non conformity details
evaluations, testing and/or reliability trials, and/or
shelf-life evaluations to validate and verify that
production of a safe and legal product is
maintained, taking account of the category
of
consumers at risk.
6.3.4 a 1 & 2 Does the company undertake product-in-use Yes No N/A
evaluations, testing and/or reliability
trials
and/or shelf-life evaluations, to validate and
verify that production of a safe and legal
product is maintained?
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Auditor remarks
CP3 Issue:1 Page "6 of Report No: Auditor:
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Section 7 Process Control
Clause
Pr
od Audit Questions
Grou
p
7.
1 Control of operations
Fundamental
The company shall be able to
demonstrate
Non conformity
details
Clause effective control of all operations undertaken, to
ensure product safety, legality, and quality and
ensure that the processes and equipment
employed are capable of producing consistently
safe and legal product with the desired quality
characteristics.
Auditor findings
7.1.1 All The company shall conduct a risk assessment of
Non conformity
details
hazards potentially introduced during the
production, packaging, or storage
processes.
7.1.1
a All Has the company conducted a risk assessment Yes No
of hazards potentially introduced during the
production, packaging or storage processes?
7.1.2 All
The company shall establish precise
process
Non conformity
details
flow(s) established and a control plan which
identifies the critical control points (if any), control
limits, monitoring points and the records required.
The company shall define how changes to
the
control plan are approved and implemented.
7.1.2
a All Are precise process flow(s) established and a Yes No
control plan in place which identifies the critical
control points (if any), control limits, monitoring
points and the records required?
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7.1.3
A
ll Preproduction meetings shall be conducted prior to
Non conformity
details
new or substantially changed products
being
produced, to evaluate and approve the processes.
7.1.3 a
A
ll Are preproduction meetings undertaken prior to Yes No
new or substantially changed products being
produced, to evaluate and approve the
processes?
7.1.3 b
A
ll Are records kept of the preproduction meetings Yes No
with actions taken?
7.1.4
A
ll Process monitoring shall be established and
Non conformity
details
adequately controlled to ensure products
are
produced within the required process specification.
7.1.4 a
A
ll Is process monitoring established and Yes No
adequately controlled to ensure products are
produced within the required process
specification?
7.1.5
A
ll Corrective action shall be taken in the event of
Non conformity
details
deviation of the process from specification. This
shall be recorded.
7.1.5 a
A
ll In the event of deviation of the process from Yes No
specification, is corrective action taken and
recorded?
7.1.6
1
&
2 The company shall have a fully implemented and
Non conformity
details
maintained process risk assessment system, based
on established principles.
7.1.6 a
1 &
2 Does the company have a fully implemented Yes No N/A
and maintained process risk assessment
system, based on established principles?
7.1.7
1
&
2 In circumstances where process parameters are
Non conformity
details
controlled by in-line monitoring devices, these shall
be linked to a suitable failure alert system
and
routinely tested.
7.1.7 a
1 &
2 Where process parameters are controlled by in Yes No N/A
line monitoring devices, are these linked to a
suitable failure alert system, routinely tested
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and records kept?
7.2
Control of incoming components and raw
materials
Fundamental The company shall have procedures to specify,
Non conformity
details
Clause validate, and approve incoming materials, which
shall include any testing, inspection, or review
of certificates of analysis.
Auditor
findings
7.2.1
A
ll Raw materials or components critical to product
Non conformity
details
safety, legality, or quality shall have documented
approval procedures to assure conformance to
agreed specifications and requirements and
documented positive batch release.
7.2.1
a
A
ll Are there documented approval procedures for Yes No
raw materials and incoming goods,
which
assure conformance to agreed specifications,
requirements and documented positive batch
release including compliance to safety
and
regulatory requirements for the country
in
which the products will be sold?
7.2.1
b
A
ll Does the company inspect or verify raw Yes No
materials and purchased parts prior to use?
Note this also includes packaging.
7.2.1
c
A
ll Is there evidence of the inspection status of Yes No
incoming components and raw
materials?
7.2.2
A
ll The requirement for documented approval
Non conformity
details
procedures as described in clause 7.2.1 shall also
apply to subcontracted work or work performed
outside the site being audited.
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7.2.2
a
A
ll
Do the incoming goods procedures
cover Yes No
subcontracted work and work performed
outside of the primary site?
7.2.3
A
ll The company shall have a documented procedure
Non conformity
details
to ensure that materials or components used by
homeworkers (when used) are approved. (See also
homeworker requirements in clause 5.6.2)
7.2.3
a
A
ll Is there a documented procedure to ensure that Yes No
materials or components used by
subcontractors are in line with specification and
approved?
7.3 Equipment & equipment maintenance
Statement
of Equipment shall be suitably designed for the
Non conformity
details
Int
ent intended purpose and shall be maintained and
used so as to minimize the risk to
product
safety, legality, and quality.
7.3.1
A
ll All equipment shall be properly specified before
Non conformity
details
commission, and operating parameters for
production equipment and tooling shall be
determined, validated, and implemented as part of
the control plan. Validation records pertinent to
safety or legality shall be kept for the lifetime of the
equipment.
7.3.1
a
A
ll Is equipment properly specified before use and Yes No
operating parameters for production equipment
and tooling determined, validated, and
implemented as part of the control plan?
7.3.1b
A
ll Does the company have a documented Yes No
procedure to ensure the machines, equipment,
fixtures, and tools are suitable for producing the
defined products on a continuing basis?
7.3.2
A
ll In the case of equipment failure or deviation of the
Non conformity
details
process from specification, procedures shall be in
place to establish the safety status of the product
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prior to release.
7.3.2
a
A
l
l In the case of equipment failure, do procedures Yes No
and records exist to establish the safety,
legality, and quality status of the product prior
to release?
7.3.3
A
l
l A documented system of planned maintenance
Non conformity
details
shall be in place, covering all items of equipment
and plant which are critical to product
safety,
legality, and quality. This shall include, but not be
limited to, records of: periodic maintenance
schedules and completion; preventative
maintenance; required safety checks; spare-parts
listings and replacements; contingency plans for
failure of essential equipment.
7.3.3
a
A
l
l
Is there a documented system for
planned Yes No
maintenance covering all items of equipment
and plant which are critical to product safety,
legality, and quality?
7.3.3b
A
l
l Are preventative maintenance schedules or Yes No
cycles documented and on schedule?
7.3.4
A
l
l Materials (for example, lubricating oils and paints)
Non conformity
details
used for equipment and plant maintenance shall be
assessed to establish whether they pose a risk by
direct or indirect contact with raw materials,
intermediate products, and finished products. If
necessary, they shall be suitably identified for the
intended use and controlled.
7.3.4
a
A
l
l Is there evidence indicating that all materials Yes No
(for example lubricating oils and paints) used
for equipment and plant maintenance has been
assessed to establish whether they pose a risk
by direct or indirect contact with raw materials,
intermediate and finished products?
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7.3.5
A
ll
Engineering workshops shall be controlled
to
Non conformity
details
prevent contamination risks to the product and be
organized, clean, and tidy to allow safe, efficient,
and good-quality work.
7.3.5 a
A
ll Are engineering and maintenance workshops Yes No
controlled to prevent contamination risks to the
product, and organized, clean and tidy to allow
safe, efficient, and good-quality work?
7.3.6
A
ll When possible, equipment shall be positioned so as
Non conformity
details
to give access beneath, inside, and around it for
ease of cleaning and servicing.
7.3.6 a
A
ll When possible, is equipment positioned so as Yes No
to give access beneath, inside and around it for
ease of cleaning and servicing?
7.3.6 b
A
ll Do machines, equipment, fixtures, tools and Yes No
measurement equipment appear to be clean in
good condition and well maintained?
7.3.7
1 &
2 In addition to any planned maintenance program,
Non conformity
details
where there is a risk of product contamination by
foreign bodies arising from equipment failure, the
equipment shall be inspected at predetermined
intervals, inspection results documented, and any
necessary corrective action taken.
7.3.7 a
1 &
2 Is there any risk of product contamination by Yes No N/A
foreign bodies arising from equipment failure?
7.3.7 b
1 &
2 Is there evidence that equipment is inspected at Yes No N/A
predetermined intervals and documented
records of inspection results?
7.3.7 c
1 &
2 Is there evidence that necessary corrective Yes No N/A
action was taken?
7.3.8 1
Certificates of conformity or other evidence
to
Non conformity
details
confirm suitability for use shall be available
for
equipment in direct contact with products,
raw
materials, and work in process.
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7.3.8
a 1 Are certificates of conformity or other evidence Yes No N/A
to confirm suitability for use, available
for
equipment in direct contact with products, raw
materials and work in process?
7.3.9 1 On completion of any maintenance work, machinery
Non conformity
details
and equipment shall be clean and free from
contamination hazards. A documented hygiene
clearance procedure shall exist.
7.3.9
a 1 Does a documented hygiene clearance Yes No N/A
procedure exist to ensure that machinery and
equipment are clean and free from
contamination hazards following maintained or
engineering work?
7.4 Foreign body detection and control
Statement
of Where deemed necessary by the documented
Non conformity
details
Int
ent risk assessment, the company shall have
systems for foreign-body detection in place to
ensure its effective operation.
7.4.1
A
l
l The company shall ensure that all necessary steps
Non conformity
details
are taken to identify and prevent the risks of
foreign-body contamination as identified by risk
assessment. This shall include any contamination
potentially introduced by the packaging.
7.4.1
a
A
l
l Has the company undertaken the necessary Yes No
steps to identify and prevent the risks of foreign
body contamination as identified by risk
assessment including any contamination
potentially introduced by the packaging?
7.4.2
A
l
l Tools and other sharp objects used in production
Non conformity
details
shall be controlled. Methods such as, but
not
limited to, the following may be used: snap-off-
blade knives prohibited; tools permanently attached
to benches; items controlled by a listing and
registration procedure; needle policy where all parts
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2010
of broken needles have to be returned prior to new
issue
.
7.4.2
a
A
ll Are tools and other sharp objects used in Yes No
production controlled?
7.4.3
A
ll Where a metal or foreign-body detector is required
Non conformity
details
or specified by the customer, the company shall
establish documented procedures specifying its
use, location, critical limits for detection, and
recording of results.
7.4.3
a
A
ll Where a metal or foreign body detector is Yes No
required or specified by the customer, do
documented procedures exist specifying its
use, location, critical limits for detection,
maintenance, and recording of results?
7.4.4
1
&
2
Except when used as part of the product,
the
Non conformity
details
presence and location of all glass, ceramic, and
brittle-plastic material in raw material handling,
preparation, processing, and packing and storage
areas shall be listed in a register. Checks of the
condition of these materials should be carried out at
a specified frequency and the results recorded.
7.4.4
a
1 &
2
Is there a procedure to identify and
control Yes No N/A
glass, ceramic, and brittle-plastic material in
raw material handling, preparation, processing,
and packing and storage areas?
7.4.4
b
1 &
2 Are checks of the condition of these materials Yes No N/A
carried out at a specified frequency and the
results recorded?
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7.4.5
1 &
2
Where they constitute a risk to the product,
a
Non conformity
details
management system that shall include
written
procedures shall be in place for all glass, brittle
plastics, and ceramics to ensure the necessary
precautions are taken. Breakages shall be
recorded and records retained.
7.4.5
a
1 &
2 Where they constitute a risk to product, are Yes No N/A
there written procedures in place for all glass,
brittle plastic, and ceramics to ensure the
necessary precautions are taken?
7.4.5
b
1 &
2 Are breakages recorded and records retained? Yes No N/A
7.4.6 1 Except when used in the product, the use of wood
Non conformity
details
within raw-material handling, preparation,
processing, packing, and storage areas shall be
eliminated except for wooden pallets, where any
risks should be evaluated and controlled.
7.4.6
a 1 Is the use of wood within raw material handling, Yes No N/A
preparation, processing, packing, and storage
areas eliminated except when used in the
product or for wooden pallets where associate
risks have been evaluated and
controlled?
7.5 Calibration and control of measuring and monitoring devices
Statement
of Measuring equipment used to monitor product
Non conformity
details
Intent safety, quality, and legality shall be identified.
The identified measuring equipment shall be
calibrated to a recognized national or
international standard. Where a
traceable
calibration is not possible, the company shall
verify the basis by which calibration is declared.
7.5.1
A
ll
The company shall identify equipment used
to
Non conformity
details
make measurements relevant to product safety,
legality, and quality.
7.5.1
a
A
ll Has all equipment used to make measurements Yes No
relevant to product safety, legality, and quality
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been identified?
7.5.2
A
l
l The equipment used in accept-or-reject activity
Non conformity
details
shall be calibrated to a specified accuracy and
precision at a defined frequency (or before use).
7.5.2 a
A
l
l
Has all equipment used in accept or
reject Yes No
activity been effectively calibrated?
7.5.3
A
l
l The calibration of identified equipment shall be
Non conformity
details
traceable to a recognized national standard. Where
such a standard does not exist, the basis by which
calibration is declared shall be verified.
7.5.3 a
A
l
l Has the calibration of identified equipment been Yes No
undertaken to recognize national standard?
7.5.4
A
l
l Records of the results of calibration and verification
Non conformity
details
shall be maintained for a suitable period, taking
account of the life of the products being produced.
7.5.4 a
A
l
l Are records of the results of calibration and Yes No
verification maintained for a suitable period
taking account of the life of the products being
produced?
7.5.5
A
l
l Identified equipment shall be prevented from being
Non conformity
details
adjusted by unauthorized staff and shall be marked
to show the calibration status and period of validity.
7.5.5 a
A
l
l
Do procedures exist to prevent
calibrated Yes No
equipment from adjustment by unauthorized
staff
?
7.5.5 b
A
l
l Is equipment marked to show the calibration Yes No
status and period of validity?
7.5.6
A
l
l The company shall define suitable test pieces and
Non conformity
details
operate a defined monitoring and testing procedure
CP3
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to identify any failure of metal/foreign body
detectors (if used).
7.5.6
a
A
ll
Is there a procedure to define suitable
test Yes No
pieces and operate a defined monitoring and
testing procedure to identify any failure
of
metal/foreign body detectors?
7.5.7
A
ll Procedures shall be in place for actions to be taken
Non conformity
details
if equipment is found not to be operating within
specified tolerances and/or limits.
7.5.7
a
A
ll Are procedures in place for actions to be taken Yes No
if equipment is found not to be operating within
specified tolerances and/or limits?
7.6 Retained production samples
Statement
of The company shall ensure the adequate and
Non conformity
details
Int
ent
secure retention of production samples
to
assist in the investigation of complaints and to
verify that production is in conformity with the
agreed specification.
7.6.1
A
ll The company shall retain a fully representative
Non conformity
details
production sample of each product as received by
the customer (including the packaging). Exceptions
may be made for products that are impractical to
store, provided the information usually provided by
a production sample can still be identified.
A
designated person shall authorize retained
production samples and/or component samples
(see also requirements in 5.1 'Preproduction
reference samples').
7.6.1
a
A
ll Does the company retain a fully representative Yes No
production sample of each product as delivered
to the customer (including the packaging), or if
impractical to store is there adequate
information available about the product?
CP3
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7.6.1
b
A
ll Is this sample selected and authorized by a Yes No
nominated person?
7.6.2
A
ll
Procedures shall be in place to determine
the
Non conformity
details
retention time of retained samples. This should
normally be the foreseeable lifetime of the product
unless otherwise justified.
7.6.2
a
A
ll Are there procedures in place to determine the Yes No
retention time of retained samples per customer
requirements and/or country of sale?
7.6.3
A
ll Retained samples shall be securely held and stored
Non conformity
details
in suitable conditions to maintain their
original
statu
s.
7.6.3
a
A
ll Are retained samples securely held and stored Yes No
in suitable conditions to maintain their original
statu
s?
7.7 Final product packing and control
Statement
of The company shall establish a procedure for the
Non conformity
details
Int
ent packing of products to ensure that products are
supplied which meet relevant safety criteria,
taking account of legal requirements and
customers' specific requirements.
7.7.1
A
ll The company shall define and validate the packing
Non conformity
details
procedure for products taking particular account of
customer requirements. That shall include methods
of ensuring that the correct product(s) and
components are correctly packaged with
and
placed in the correct outer packaging.
7.7.1
a
A
ll Do procedures exist to specify and control the Yes No
packing of finished product, taking into account
customers requirements?
7.7.2
A
ll Quantity markings on the product or pack should be
Non conformity
details
accurate, verified, and in accordance with the legal
requirements in the country of sale.
CP3
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7.7.2 a All Do procedures exist to verify the accuracy of Yes No
the quantity markings on the product or pack
accurate, verified, and in accordance with the
legal requirements in the country of sale?
7.7.3 All The company shall verify that information shown on
Non conformity
details
primary (consumer) package labels and outer
cartons is correct and meets the regulatory and
safety requirements of the region of intended sale.
7.7.3 a All Has the company verified that the information Yes No
shown on primary (consumer) package labels
including bar codes, and outer cartons are
correct and meet the customer specification,
regulatory and safety requirements of the
region of intended sale?
Auditor remarks
CP3 Issue:1 Page ' of Report No: Auditor:
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Section 8
Personnel
Claus
e
Produ
ct Audit Questions
Group
8.1 Training and competency
Fundamental The company shall ensure that personnel performing Non conformity details
Clause work that affects product safety, legality, and quality
are demonstrably competent to carry out their activity,
through training, work experience, or qualification.
Auditor findings
8.1.1 All The company shall ensure that all employees are able to Non conformity details
demonstrate competence with regards to their activity. The
company shall: identify the need for training; document
training procedures and records to demonstrate that training
is effective and regularly reviewed; ensure that training
includes both general information on the company and
specific job training.
8.1.1
a All Does the company identify the need for training with Yes No
regard to who is to be trained and the type of training
require
d?
8.1.1
b All Has the identified training been provided? Yes No
8.1.1
c All Does the company provide or verify training programs Yes No
tailored to employees directly involved in the
manufacturing, quality control, production, lab
calibration and equipment maintenance?
8.1.1
d All Does the training of QC employees and/or employees Yes No
conducting inspection include how to conduct
inspections and how to identify defects that can occur
CP3 Issue:1
Page !
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in the product being manufactured?
8.1.1
e
A
ll Is the satisfactory completion of training verified Yes No
through testing and monitoring?
8.1.1
f
A
ll Are minimum standards set for the satisfactory Yes No
completion of training?
8.1.1
g
A
ll Is retraining provided when a need has been identified? Yes No
8.1.2
A
ll Employees having direct effect on the safety, quality, or Non conformity details
legality of products shall be trained to ensure understanding
of risk assessment procedures or outcomes as necessary
for their activity. Those conducting or participating in risk
assessments shall be adequately trained in risk assessment
method
s.
8.1.2
a
A
ll Are employees with direct effect on product safety, Yes No
quality and legality adequately
trained?
8.1.2
b
A
ll Is there specific training for risk assessment? Yes No
8.1.3
A
ll Training records should be stored such that privacy of Non conformity details
personnel is protected and legal compliance with data
protection laws in the country of operation are respected
whilst also allowing auditors access to necessary
information. Training shall be traceable to an individual
employ
ee.
8.1.3
a
A
ll Are training records maintained that are traceable to Yes No
the individual employee?
8.1.3 A Do the training records provide date of training, Yes No
b ll
contents of training, training duration and assessment
result?
8.1.3
c
A
ll Is there a defined retention period for training records, Yes No
which is appropriate?
8.1.3
d
A
ll Are the training records kept current, complete and Yes No
accurat
e?
8.2 Protective clothing
CP3
Issue:1 Page 1 of Report No: Auditor:
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2010
Audit Report
Scorecard
Statement of The company's standards shall be documented and
Non conformity
details
Intent adopted by all personnel, including contractors and
visitors to the production facility.
8.2.1 All Where a need for protective clothing has been identified by
Non conformity
details
the risk assessment, this shall not pose a contamination risk
to the product.
8.2.1
a All Has the company appropriately identified the need for Yes No
protective clothing/equipment to prevent product
contaminator and preserve product integrity?
8.2.1
b All Are employees wearing the protective clothing as Yes No
defined to prevent product contamination and preserve
product integrity?
8.2.2 1 & 2 Based on the assessment of risk to the product, suitable
Non conformity
details
footwear shall be worn within the factory environment if
necessary.
8.2.2
a 1 & 2 Based on the assessment risk to the products, is Yes No N/A
suitable footwear being worn in the factory?
8.2.3 1 & 2 Protective clothing, where provided, shall be effectively
Non conformity
details
laundered at an appropriate frequency.
8.2.3
protective clothing, where provided, effectively
laundered at an appropriate frequency?
8.2.4 1 & 2 Disposable protective clothing, if used, shall be subject to
Non conformity
details
adequate control to avoid product contamination.
8.2.4
disposable protective clothing, if used, subject to
adequate control to avoid product contamination?
8.3 Hygiene practices
Statement of Standards of hygiene shall be formulated with due
Non conformity
details
Intent regard to the risk of product contamination.
portrait 26//1! "
Audit Report
Scorecard
8.3.1
1
&
2 Where metal foreign-body detection is in place, detectable
Non conformity
details
plasters shall be used and shall be regularly tested through
the detector.
8.3.1 a
1
&
2 Based on the assessment risk to the products, where Yes No N/A
metal foreign body detection is required, are detectable
adhesive bandages used and regularly tested through
the detector?
8.3.2
1
&
2 The company shall have a policy to control the wearing of
Non conformity
details
jewelry so that it poses no risk of product contamination.
8.3.2 a
1
&
2 Based on the assessment risk to the products, does the Yes No N/A
company have a policy to control the wearing of jewelry
so that it poses no risk to product contamination?
8.3.3 1 All cuts and grazes on exposed skin shall be covered by
Non conformity
details
contrasting coloured plasters that is company issued and
monitor
ed.
8.3.3 a 1 Based on the assessment risk to the products, are all Yes No N/A
cuts and grazes on exposed skin covered by a
contrasting colored bandage that is company issued
and monitored?
8.3.4 1 Hand-cleaning shall be performed at a suitable frequency to
Non conformity
details
maintain hygienic conditions.
8.3.4 a 1 Based on the assessment risk to the products, is hand Yes No N/A
cleaning performed at a suitable frequency to maintain
hygienic conditions?
8.3.5 1 No eating, drinking, or smoking shall be permitted within
Non conformity
details
production or packaging
areas.
8.3.5 a 1 Based on the assessment risk to the products, is Yes No N/A
eating, drinking or smoking restricted from within
production or packaging areas?
8.3.6 1 All head and facial hair shall be fully contained to prevent
Non conformity
details
product contamination.
8.3.6 a 1 Based on the assessment risk to the products, is all Yes No N/A
head and facial hair fully contained to prevent product
contamination?
CP3
Issue:1
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8.3.7 1 The company shall be vigilant concerning employees, Non conformity details
including temporary employees, when they may be
suffering from or have been in contact with any relevant
infectious disease or condition. The company should have
a procedure for the notification by employees where this is
legally allowable.
8.3.7 a 1 Is the company vigilant regarding employees (including Yes No N/A
temporary employees) who may be suffering or have
been in contact with any relevant infectious disease or
condition?
8.3.7 b 1 Does the company have a procedure for the Yes No N/A
notification by employees where this is legally allowed?
8.3.8 1 Where the company becomes aware of a person who has Non conformity details
entered the premises suffering from a relevant infectious
disease, steps shall be taken to minimize any risk to
product safety.
8.3.8 a 1 When the company becomes aware of a person who Yes No N/A
has entered the premises suffering from a relevant
infectious disease, can they demonstrate they have
taken steps to minimize any risk to product safety?
8.3.9 1 Where there may be risk to product safety, and where Non conformity details
legally allowable, visitors and contractors shall be required
to complete a health questionnaire prior to entering the raw-
material, preparation, processing, packing, and storage
areas. If necessary, these persons shall undergo medical
screening before permission is granted to enter the raw-
material, preparation, processing, packing, and storage
areas.
8.3.9 a 1 Did all visitors and contractors complete a health Yes No N/A
questionnaire prior to entering the raw material,
preparation, processing, packing and storage areas?
8.3.9 b 1 If necessary, did these persons undergo medical Yes No N/A
screening before permission is granted to enter the raw
material, preparation, processing, packing and storage
areas?
CP3
Issue:1 Page ( of Report No: Auditor:
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8.3.10 1 Fingernails shall be kept short, clean, and unpolished. Non conformity details
False fingernails are not permitted.
8.3.10 1 Based on the assessment risk to the products, are Yes No N/A
a fingernails kept short, clean and unpolished?
8.3.10 1 Based on the assessment risk to the products, is there Yes No N/A
b demonstration that false fingernails are not permitted?
Audit
or
remark
s
*****
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CP3 Issue:1 Page " of Report No: Auditor:
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Global Standard for Consumer Products Issue 3: February 2010

Audit Report Scorecard

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