INSPECTION DEPARTMENT ASSESSMENT CHECKLIST

Item

Results
Source

S, U,
N/E,
N/A

Quality Requirement

Comments

Organization being Assessed: ER -10-03540 SIEMENS LTD Saudi Arabia

Area being assessed: QP for IK Procurement and Construction Activities

ISO
9001
4.1.1
ISO
9001
4.1.1
ISO
9001
4.1.2.1
ISO
9001
4.1.2.2
ISO
9001
4.1.2.3

ISO
9001
4.1.3

Date of Assessment:

9/17/2002

Has the contractor's management with executive

responsibility defined and documented its policy for
quality, including objectives for quality and its commitment
to quality. (ISO 9001 4.1.1)
Is the quality policy relevant to the contractor's
organizational goals and the expectations and needs of its
customers? (ISO 9001 4.1.1)

Section 1.0, para. 1.1 defines Siemens Quality Policy

Policy is relevant to the Contractors organizational

goals as well as Customer requirements, which are
included in the Preface.

Does the contractor shall ensure that this policy is

understood, implemented, and maintained at all levels of
the organization? (ISO 9001 4.1.1)
Has the contractor defined the responsibility, authority, and
the interrelation of personnel who manage, perform, and
verify work affecting quality? (ISO 9001 4.1.2.1)
Does the contractor identify resource requirements and
provide adequate resources, including the assignment of
trained personnel for management, performance of work,
and verification activities including internal quality audits. .
(ISO 9001 4.1.2.2)
Has the contractors management with executive
responsibility appointed a member of the contractor's own
management who, has defined authority for
a) ensuring that a quality system is established,
implemented, and maintained in accordance with this
American National Standard.
b) reporting on the performance of the quality system to
the contractors management for review and as a basis for
improvement of the quality system? (ISO 9001 4.1.2.3)
Does the contractor's management with executive
responsibility review the quality system at defined intervals
sufficient to ensure its continuing suitability and

It is binding to SIEMENS LTD and sub-contractor

personnel equally.

Contractor has defined the levels of authority and

responsibilities of personnel whose work affects quality.

According to Sec.16 of QA Program, Audits will be

performed by AEL Project Management Team.

And Part II Preface

** Note: Aramco will still need to review certifications

and qualifications of all contract auditors.
S

Quality Control Manager

Quality Management Committee which is comprised of

senior Execs will be formed to monitor and review the
Siemens Quality Management System. This will be held

INSPECTION DEPARTMENT ASSESSMENT CHECKLIST

Item

Results
Source

ISO
9001
4.2.1

ISO
9001
4.2.2
ISO
9001
4.2.2
ISO
9001
4.2.3
ISO
9001
4.3.1
ISO
9001
4.4.1

ISO

S, U,
N/E,
N/A

Quality Requirement

effectiveness in satisfying the requirements of this

American National Standard and the contractor's stated
quality policy and objectives (see 4.1.1). Are records of
such reviews maintained? (ISO 9001 4.1.3)
Has the contractor established, documented, and
maintained a quality system as a means of ensuring that
service conforms to specified requirements. Does the
quality manual include or make reference to the qualitysystem procedures and outline the structure of the
documentation used in the quality system. (ISO 9001
4.2.2)
Has the contractor prepared documented procedures
consistent with the requirements of the ISO 9001 Standard
and the contractor's stated quality policy? (ISO 9001
4.2.2)
Has the contractor effectively implemented the quality
system and its documented procedures? (Internal audits,
etc) (ISO 9001 4.2.2)
Does the contractor provide for systematic quality
planning to ensure that requirements of service orders are
consistently being met? (ISO 9001 4.2.3)
Has the contractor established and maintained documented
procedures for contract review and for the coordination of
those activities. (ISO 9001 4.3.1)
4.4.1 General

every six months. Per section 1.4 of QP.

Siemens has submitted procedures for most of the ISO9001 elements except; Process Control, Identification
and Traceability, Status of Inspections and tests, and
Training of personnel.

Some, but incomplete as to ISO 9001 Standard (see

previous block)

Internal audit procedure is part of the Siemens program,

but this is being performed by a third party agency.

Quality System (per plan) is based on the guidelines of

ISO-9001-1994 Standard

There are no documented procedures defining how

Siemens will control Contract Review aspects of job.
Contract Review is referenced in QA Manual Portion of
Quality Plan.

Siemens will submit a design phase Quality Plan to

Saudi Aramco within 45 days after effective date of the
Contract.

The supplier shall establish and maintain documented

procedures to control and verify the design of the product
in order to ensure that the specified requirements are met.
(ISO 9001 4.4.1)
4.4.2 Design and development planning

Comments

Siemens needs to submit Design Phase Quality Plan as

submitted documentation in Quality Plan per this review
is inadequate.
N/E

This element was not evaluated. Need to submit Design

INSPECTION DEPARTMENT ASSESSMENT CHECKLIST

Item

Results
Source

9001
4.4.2

ISO
9001
4.4.3

ISO
9001
4.4.4

ISO
9001
4.4.5

Quality Requirement

S, U,
N/E,
N/A

Comments

Phase Quality Plan.

Does the supplier prepare plans for each design and
development activity? The plans shall describe or reference
these activities, and define responsibility for their
implementation. The design and development activities
shall be assigned to qualified personnel equipped with
adequate resources. The plans shall be updated, as the
design evolves.
4.4.3 Organizational and technical interfaces

N/E

This element was not evaluated. Need to submit Design

Phase Quality Plan.

Organizational and technical interfaces between different

groups which input into the design process shall be defined
and the necessary information documented, transmitted,
and regularly reviewed.
4.4.4 Design input

N/E

This element was not evaluated. Need to submit Design

Phase Quality Plan.

Design-input requirements relating to the product,

including applicable statutory and regulatory requirements,
shall be identified, documented, and their selection
reviewed by the supplier for adequacy. Incomplete,
ambiguous, or conflicting requirements shall be resolved
with those responsible for imposing these requirements.
4.4.5 Design output

N/E

This element was not evaluated. Need to submit Design

Phase Quality Plan.

Design output shall be documented and expressed in terms

that can be verified against design-input requirements and
validated (see 4.4.8).
Design output shall:
a)
b)
c)

meet the design-input requirements;

contain or make reference to acceptance criteria;
identify those characteristics of the design that are

N/E

This element was not evaluated. Need to submit Design

Phase Quality Plan.

INSPECTION DEPARTMENT ASSESSMENT CHECKLIST

Item

Results
Source

ISO
9001
4.4.6

ISO
9001
4.4.7

Quality Requirement

S, U,
N/E,
N/A

Comments

crucial to the safe and proper functioning of the product

(e.g., operating, storage, handling, maintenance, and
disposal requirements).
Design-output documents shall be reviewed before release.
4.4.6 Design review

N/E

This element was not evaluated. Need to submit Design

Phase Quality Plan.

At appropriate stages of design, formal documented

reviews of the design results shall be planned and
conducted. Participants at each design review shall include
representatives of all functions concerned with the design
stage being reviewed, as well as other specialist personnel,
as required. Records of such reviews shall be maintained.
4.4.7 Design verification

N/E

This element was not evaluated. Need to submit Design

Phase Quality Plan.

At appropriate stages of design, design verification shall be

performed to ensure that the design-stage output meets the
design-stage input requirements. The design-verification
measures shall be recorded (see 4.16).
NOTE 10 In addition to conducting design reviews (see
4.4.6), design verification may include activities such as
--performing alternative calculations,
--comparing the new design with a similar proven design, if
available,
N/E

This element was not evaluated. Need to submit Design

Phase Quality Plan.

--undertaking tests and demonstrations, and

ISO
9001
4.4.8

--reviewing the design-stage documents before release.

4.4.8 Design validation
Design validation shall be performed to ensure that

N/E

This element was not evaluated. Need to submit Design

Phase Quality Plan.

INSPECTION DEPARTMENT ASSESSMENT CHECKLIST

Item

Results
Source

S, U,
N/E,
N/A

Quality Requirement

Comments

product conforms to defined user needs and/or

requirements.
NOTES
11
Design validation follows successful design
verification (see 4.4.7).
12
Validation is normally performed under defined
operating conditions.
13
Validation is normally performed on the final
product, but may be necessary in earlier stages prior to
product completion.

ISO
9001
4.4.9
ISO
9001
4.5.1
ISO
9001
4.5.2

14
Multiple validations may be performed if there are
different intended uses.
4.4.9 Design changes
All design changes and modifications shall be identified,
documented, reviewed, and approved by authorized
personnel before their implementation.
Has the contractor established and maintained documented
procedures to control all documents and data that relate to
the requirements of this American National Standard
including, to the extent applicable, documents of external
origin such as standards and customer drawings?
The documents and data shall be reviewed and approved
for adequacy by authorized personnel prior to issue.
A master list or equivalent document-control procedure
identifying the current revision status of documents shall
be established and be readily available to preclude the use

N/E

This element was not evaluated. Need to submit Design

Phase Quality Plan.

N/E

This element was not evaluated. Need to submit Design

Phase Quality Plan.

Document Control is documented in Part II section 5 of

the Quality Assurance program

A Master Control List is demonstrated for control of

quality and contract documentation in form CR-GE-

INSPECTION DEPARTMENT ASSESSMENT CHECKLIST

Item

Results
Source

S, U,
N/E,
N/A

Quality Requirement

of invalid and/or obsolete documents.

This control shall ensure that:
a)
the pertinent issues of appropriate documents are
available at all locations where operations essential to the
effective functioning of the quality system are performed;

002-01.

Data base shall be revised and steps taken to replace old

document from files and/or folders with the new revision
per section 5.5 of Document Control Procedure.

Only current documentation shall be used at worksites

and work areas per section 5.3

Changes in documentation will be revised on the data

base, which will be updated and steps taken to replace
old version of the same document from document file
and other holders. Change control for documentation
changes and field modifications are also demonstrated in
Section 8.0 Recording Field Mods/Changes

b)
invalid and/or obsolete documents are promptly
removed from all points of issue or use, or otherwise
assured against unintended use;

ISO
9001
4.5.3

c)
any obsolete documents retained for legal and/or
knowledge-preservation purposes are suitably identified.
4.5.3 Document and data changes
Changes to documents and data shall be reviewed and
approved by the same functions/organizations that
performed the original review and approval, unless
specifically designated otherwise. The designated
functions/organizations shall have access to pertinent
background information upon which to base their review
and approval.

S
Revisions on Inspection and Test Plans shall be
submitted to the client for review and approval prior to
distribution and implementation.

Where practicable, the nature of the change shall be

identified in the document or the appropriate attachments.
ISO
9001
4.13.1

4.13.1 General
The supplier shall establish and maintain documented
procedures to ensure that product that does not conform
to specified requirements is prevented from unintended use
or installation. This control shall provide for identification,
documentation, evaluation, segregation (when practical),

Comments

Contractor has procedures to ensure materials,

Customer Supplied Product and handling, control and
storage of materials are performed to ISO program
requirements.

INSPECTION DEPARTMENT ASSESSMENT CHECKLIST

Item

Results
Source

S, U,
N/E,
N/A

Quality Requirement

Comments

disposition of nonconforming product, and for notification

to the functions concerned.
4.13.2 Review and disposition of nonconforming product

Identification of non-conformances, preparation of nonconformance reports and corrective action is

demonstrated in Siemens Procedure, Section 13 of
Quality Procedures.

The responsibility for review and authority for the

disposition of nonconforming product shall be defined.
Nonconforming product shall be reviewed in accordance
with documented procedures. It may be
a)

reworked to meet the specified requirements,

Yes

b)

accepted with or without repair by concession,

Yes

c)

re-graded for alternative applications, or

d)

Rejected or scrapped.

Yes

Where required by the contract, the proposed use or repair

of product (see 4.13.2b) which does not conform to
specified requirements shall be reported for concession to
the customer or customer's representative. The description
of the nonconformity that has been accepted, and of
repairs, shall be recorded to denote the actual condition
(see 4.16).
Repaired and/or reworked product shall be re-inspected in
accordance with the quality plan and/or documented
procedures.

A Scrap or Return Label will be placed on the product

and the product segregated to prevent misuse and sub
sequentially returned to the supplier.

INSPECTION DEPARTMENT ASSESSMENT CHECKLIST

Item

Results
Source

S, U,
N/E,
N/A

Quality Requirement

Comments

ISO
9001
4.13.2

The responsibility for review and authority for the

disposition of nonconforming product shall be defined.

QA Manager shall review NCR Log if NCR are left

open for longer than 20 days the NCR shall be elevated
to the attention of the Project Manager. Per 13.7 para.
2.

ISO
9001
4.14.1
ISO
9001
4.14.2

Does the contractor establish and maintain documented

procedures for implementing corrective and preventive
action.
Do the procedures for corrective action shall include:
a) the effective handling of customer complaints and
reports of service nonconformities;

Section 13.8

Yes

b) investigation of the cause of nonconformities relating to

product, process, and quality system, and recording the
results of the investigation;

Yes

c) determination of the corrective action needed to

eliminate the cause of nonconformities;

ISO
9001
4.14.3

S
d) application of controls to ensure that corrective action is
taken and that it is effective.
Does the procedures for preventive action include:
S
a) the use of appropriate sources of information such as
processes and work operations which affect product
quality, concessions, audit results, quality records, and
customer complaints to detect, analyze, and eliminate
potential causes of nonconformities;
b) determination of the steps needed to deal with any
problems requiring preventive action;
c) initiation of preventive action and application of controls
to ensure that it is effective;

Yes
Yes
Processes and work operations shall be evaluated to
identify weak areas.
Minor preventive action proposals that can be
implemented directly shall be directed to the Work
Supervisor.
Steps needed will be determined on a case by case basis

INSPECTION DEPARTMENT ASSESSMENT CHECKLIST

Item

Results
Source

ISO
9001
4.16

ISO
9001
4.17

S, U,
N/E,
N/A

Quality Requirement

d) confirmation that relevant information on actions taken

is submitted for management review (see 4.1.3).
Does the contractor establish and maintain documented
procedures for identification, collection, indexing, access,
filing, storage, maintenance, and disposition of quality
records.

Comments

Discipline supervisors are responsible for the collection,

change control and data filing and indexing for their
divisions.

Quality records shall be maintained to demonstrate

conformance to specified requirements and the effective
operation of the quality system. Pertinent quality records
from the subcontractor shall be an element of these data.

Quality Records will be maintained by QA Management.

All quality records shall be legible and shall be stored and

retained in such a way that they are readily retrievable in
facilities that provide a suitable environment to prevent
damage or deterioration and to prevent loss. Retention
times of quality records shall be established and recorded.
Where agreed contractually, quality records shall be made
available for evaluation by the customer or the customer's
representative for an agreed period.
Does the contractor establish and maintain documented
procedures for planning and implementing internal quality
audits to verify whether quality activities and related
results comply with planned arrangements and to
determine the effectiveness of the quality system.

Procedure 7.0 does not indicate the manner in which

quality documentation will be stored and handled and
what retention periods are required.

Section 16.0 Internal Quality Audit Procedure

Internal quality audits shall be scheduled on the basis of the S

status and importance of the activity to be audited and
shall be carried out by personnel independent of those
having direct responsibility for the activity being audited.

QA Manager shall be responsible for the establishment

of the audit schedule.

The results of the audits shall be recorded (see 4.16) and

brought to the attention of the personnel having

Results of the audit shall be made available by the QA

Manager to the Project Manager.

INSPECTION DEPARTMENT ASSESSMENT CHECKLIST

Item

Results
Source

S, U,
N/E,
N/A

Quality Requirement

responsibility in the area audited. The management

personnel responsible for the area shall take timely
corrective action on deficiencies found during the audit.

ISO
9001
4.18

Follow-up audit activities shall verify and record the

implementation and effectiveness of the corrective action
taken (see 4.16).
Does the contractor establish and maintain documented
procedures for identifying training needs and provide for
the training of all personnel performing activities affecting
quality. Personnel performing specific assigned tasks shall
be qualified on the basis of appropriate education, training,
and/or experience. Appropriate records of training shall be
maintained (see 4.16).

S
U

Comments

QA Manager shall follow up any corrective actions as a

result of the audit with the auditee.
There are no procedures available for review to
demonstrate how the Contractor handles the training
and indoctrination of quality personnel.