Section: 8

Quality Management System Manual Revision: 3.6

Date: 08.03.2023
No. of Pages: 8

8.0 OPERATION
8.1 Operational planning and control
For effectively planning, implementing and controlling the key processes and for meeting the
product requirements, following actions are implemented.
a. The product requirements are determined.
b. Criteria for monitoring the process and service levels established.
c. Resources needed for achieving required service levels are determined.
d. Required control of the processes in line with the criteria is implemented.
e. Documented information to the extent necessary is identified and kept having confidence that
the processes have been carried out as planned and to demonstrate the conformity of services
to their requirements.
It is ensured that the above planning details are suitable for the company operations. The changes
required are planned, controlled and reviewed for the consequences of unplanned and unintentional
changes are considered to mitigate adverse effect. Sufficient controls are established on the outsource
processes / services.

8.2 Requirements for services

8.2.1 Customer communication
Sales and Marketing team handles communication arrangements with all customers. The
Communication is through direct interactions and e-mails. This relates to
o Information relating to products offered / supplied.
o Replies to enquiries, contract orders including amendments.
o Customer feedback / complaints.
o Handling / controlling customer property if any
o Specific requirements of contingency actions when relevant

8.2.2 Determination of requirements related to products and services

When finalizing the product requirement; the company ensures that
a. The commercial and technical requirements are defined covering statutory regulatory
requirements as applicable and other requirement consider by the company.

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Quality Management System Manual Revision: 3.6
Date: 08.03.2023
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b. The company has the capability to meet requirements of the product and claim for the
products supplied.
8.2.3 Review of requirements related to products and services
8.2.3.1 At the time of initial interaction and finalizing the product requirements, company’s ability to
meet the requirement is ensured. A review is conducted before communicating the product details to
the customer which include
a. Requirements specified by the customer
b. Requirements not specified but required to be meet for specified use
c. Requirement specified by the company
d. Obligation related to service, including regulatory / legal requirements
e. Changes in the service requirement from the earlier offered are identified and met
The organization shall ensure that, any changes in the requirements from original requirements are
captured and followed for the further process. The customer’s requirements are confirmed by the
organization before acceptance.

8.2.3.2 Documented information of the results of order review and changes are maintained.

8.2.4 Changes to requirement for products and services

Whenever product requirements are changed, then specifications and other documentations are
suitably amended, and relevant personnel are made aware of new / changed requirements.

8.3 Design Development of Products and Services

8.3.1 General
MIPL has established, implemented and maintained a design and development process that is suitable
to produce various products as specified in the scope of Quality Management System.

8.3.2 Design and Development Planning

Design and Development projects are carefully planned and controlled at all stages. The design and
development plans indicate:
a) Stages of design and development processes
b) Identify or finalize the internal / external resources requirements for design & development

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Quality Management System Manual Revision: 3.6
Date: 08.03.2023
No. of Pages: 8

c) Review, verification and validation activities are planned and carried out at required stages
either separately or together
d) Responsibilities and authorities for activities described
e) Consider the requirements of interested parties.

8.3.3 Design and Development Input

Various inputs relating to product / service requirements are identified and documented for each
project. This includes:
a) Functional, physical, performance and aesthetic requirements
b) Applicable regulatory / legal requirements
c) Information derived from previous similar designs / projects
d) Other requirements essential for design and / or manufacture
These inputs are reviewed, and any incomplete or conflicting requirements are resolved.

8.3.4 Design and / or Development Controls

At specified stages of design and development reviews are conducted to
a) Evaluate the fulfillment of requirements
b) Identify problems and implement follow-up actions
c) Design verification is done to ensure that design and development outputs meet the design and
development input requirements
d) Design and development validation is carried out to confirm that, the final product meets the
requirements in specified working conditions
e) If full validation is not practical, then validation is performed to the extent possible
f) Documented the action taken details against problems faced during review, verification and
validation.
Participants of this review include representatives from relevant functions. The results of review and
follow-up actions are recorded and maintained in project files.

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Quality Management System Manual Revision: 3.6
Date: 08.03.2023
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8.3.5 Design and Development Output

The design and development outputs are documented through assembly, component drawings, bill of
materials, product / test specifications and verified against input requirements. It is ensured that the
design output
a) Meets the input requirements defined
b) Provides information for purchase, production and servicing
c) Contains or refers to acceptance criteria
d) Requirements for preservation, safe and proper use of the product.
All output documents are reviewed and approved before release to the user department.

8.3.6 Control of Design and Development Changes

Changes to design / components are identified, documented and controlled. This includes evaluation of
the effect of changes on the basic design and impact on the already delivered products. The changes
are verified, validated and approved before implementation. The result of review and follow-up actions
are documented and maintained in project files.

8.4 Control of externally provided processes, products and services

8.4.1 General
It is ensured that externally provided (purchased / out sourced) products and services conform to the
requirements. Various controls that are being applied over the external agencies during the following
situations are identified and implemented;
a) Product and services are incorporated on companies own products (purchase of services and
equipment for calibration lab)
b) Services directly provided to the customers by the external agencies like transport / courier
services
c) Outsourced process like calibration that is carried out by external sources as the result of
company’s decision
The suppliers / service providers are evaluated and selected based on their ability to meet the company
requirements. The criteria for selection, evaluation, monitoring of performance and re-evaluation are
defined in the purchase procedure. The results of evaluation and follow-up action are maintained.

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8.4.2 Type and extent of control

MIPL ensures that externally provided processes and services do not affect the consistency of delivery
and conformance of products manufactured. To achieve this following controls are established
a. Ensuring that both purchase and outsource processes are well within the control of Quality
Management System.
b. Controls over both supplier and out sourcing are defined.
c. The impact of purchased / outsourced product, process and services on companies own ability
to meet customer, statutory regulatory requirements and effectiveness of controls that are
available with external service provider are taken into the consideration.
d. Verification and other activities like supplier evaluation and initial approval are carried out to
ensure that the externally provided processes, and services meet requirements.

8.4.3 Information for external providers

Purchasing information is provided in the purchase order, contract / agreement describing the
product / services ordered. The data provided include as appropriate
a. The processes, products and service to be provided.
b. Approval requirements like dimensions, specifications for acceptance of items (Equipment /
Instruments)
c. Competence, required qualifications of persons as applicable.
d. Details of external provider’s interaction with company.
e. Control and monitoring of the external provider’s performance to be implemented by the
company.
f. Verification/ validation activities that the company / its customer, intends to perform at the
external provider’s premises.

8.5. Production and Service provision

8.5.1 Control of Production and Service Provision
The production operations are carried out under controlled conditions, which include as applicable
a. Availability of information specifying the product characteristics / requirements and results to
be achieved.
b. Availability and issue of correct measuring / monitoring devices.

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c. Implementation of required measuring and monitoring activities at various stages to verify that
the criteria for the control, output and defined acceptance criteria of the product are met.
d. Suitable infrastructure and environment required for the process.
e. Availability of competence persons including qualification details.
f. Implementing actions to prevent human error.
g. Implementation of release, delivery and port delivery activities.

8.5.2 Identification and Traceability

One or more of the following methods are used to identify the product during various stages.
 Display names, identification tags, code numbers.
 Reference number as applicable.
 Registers / Certificates / test report.
 Identified location.
Traceability is maintained at the final delivery stage for tracking post-delivery issues. All products are
identified with a reference number. The internal records have cross-reference to this so that in case of
complaints, records can be traced and crosschecked if necessary.

8.5.3 Property belonging to customers or external providers

Adequate care is exercised on customer property (which includes intellectual property and customer
data) if used for processing. Customer supplied items are identified, verified, preserved and safe
guarded. Any quantity lost, damaged or found unsuitable are reported to the customer and records are
maintained.

8.5.4 Preservation
The outputs are properly preserved during entire internal processing till dispatch. This includes proper
identification, handling, packaging, storage and other protections at all stages.

8.5.5 Post-delivery activities

The requirements related to post-delivery activities associated with product are met. When
determining the extend of post-delivery activities are required, the following issues are considered
a. Statutory and regulatory requirements;

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Quality Management System Manual Revision: 3.6
Date: 08.03.2023
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b. Potential undesired consequences associated with its services;

c. The nature, use and intended lifetime of its services;
d. Customer requirements;
e. Customer feedback.

8.5.6 Control of changes

Whenever changes required in the product they are reviewed and controlled to the extent
necessary for ensuring continued conformity to the requirement.
The documented information describing the results of review of changes, the persons
authorizing the change, and any necessary actions arising from the review are maintained.

8.6 Release of products and services

The product is tracked at receiving, in-process and final defined stages of manufacture against
the Quality plans defined. Compliance to these requirements is monitored after completion of agreed
stages.
Products / Services are delivered only after ensuring that all the activities are satisfactorily
completed, unless and otherwise approved by the customer.
Evidence of conformity is documented through inspection reports / records. These records also
indicate the person approving them.

8.7 Control of Non-conforming outputs

8.7.1 Products that do not conform to requirement are identified and controlled to prevent its
unintended use / delivery to customer.
Depending on the non-conformity and its impact on the service level suitable actions are initiated. This
include detecting the issues during various stages of delivery and after providing the service / project
completion.
The controls include,
a. Correction
b. Segregation, containment, return, or suspending the delivery of the parts
c. Informing the customer

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d. Release under concession with the approval of relevant authority (with customer approval if
required)
Conformity to the requirements are re-verified whenever the outputs are corrected.

Incoming, in process and final inspection are carried out by Quality engineers and the output of
inspection is recorded in the reports. If any non-conformances are identified, they are recorded in
Nonconformity (NC) report and forwarded to the respective departments to initiate corrective actions.
It may include the actions taken by respective suppliers, wherever required. The corrective actions
initiated are discussed in Monthly meetings and in MRM.
In case of request for concessional acceptance, the HOD of Quality Assurance / Design or CEO shall
accept the concession request based on the nature of the problem. If required, customers are also
involved in this.

If rework is carried out in any component or product, reverification is carried out by Quality engineers
and the relevant reports are maintained.

8.7.2 The documented information retained include

a. Description of the nonconformity
b. Details of the actions taken
c. Description of the concessions obtained
d. Person authorized the action with respect the non-conformity.

Reference Formats

Concession Note F-QM8-1

List of Records

Sl. No Record Name Record No Retention Time Location Responsibility

Concession Note SharePoint / ISO QA /
1 R-QM8-1 3 Years QC / QA
Approval QA-QC-ISO Documents

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