ABC COMPANY LIMITED

QUALITY MANAGEMENT SYSTEM MANUAL

PROCEDURE FOR CONTROL AND VALIDATION OF PRODUCTION

1. PURPOSE:

To establish a system to ensure that …

a) Production is planned and carried out under controlled conditions, and
b) Processes for production are validated and periodically revalidated in cases where the resulting output
cannot be verified by subsequent monitoring or measurement.

2. SCOPE:

All manufacturing activities carried out at the organization’s factory.

3. DEFINITIONS:

NIL

4. REFERENCES:

ISO9001:2015 standard - Clause 8.5.1 Control of production and service provision

5. AUTHORITY AND RESPONSIBILITY:

Head (Production)

He / she is responsible for implementation of this procedure.

He / she has the authority to decide on matters related to production activities.

6. Method:

Our organization carries out production activities under controlled conditions.

Controlled conditions include, as applicable:

a) the availability of documented information that defines
1) the characteristics of the products to be produced, or the activities to be performed
2) the results to be achieved
b) the availability and use of suitable monitoring and measuring resources
c) the implementation of monitoring and measurement activities at appropriate stages to verify that criteria for
control of processes or outputs, and acceptance criteria for products, have been met
d) the use of suitable infrastructure and environment for the operation of processes
e) the appointment of competent persons, including any required qualification
f) the validation, and periodic revalidation, of the ability to achieve planned results of the processes for
production, where the resulting output cannot be verified by subsequent monitoring or measurement
g) the implementation of actions to prevent human error, and
h) the implementation of release, delivery and post-delivery activities.

Prepared by Reviewed & Approved by Issued by Doc. Control

Doc ID: COMP-OPP-01
Signature Version: 001
Date 01-Oct-2015 01-Oct-2015 01-Oct-2015 Effective date: 01-Oct-2015
Designation QMR MD QMR Page 1 of 4
 ABC COMPANY LIMITED
QUALITY MANAGEMENT SYSTEM MANUAL
PROCEDURE FOR CONTROL AND VALIDATION OF PRODUCTION

The detailed procedure is given below:

a) Production Planning and Control

The Head (Marketing) regularly issues work orders to the Head (Production) mentioning the items to be
manufactured, quantities, and due date(s).

The Head (D&D) issues work orders (as and when required for design & development projects) to the Head
(Production) mentioning the items to be made, quantities, and due date(s).

At the end of every month, the Head (Production) plans out next month’s production (with weekly break-up) on
the basis of work orders, available manpower, and other resources.

Copy of this monthly plan is sent to the Head (Purchase & Stores) alongwith purchase requisition for materials
required.

At the end of every week, the Head (Production) reviews the week's performance and make changes to the
production plan for coming weeks if required. If any work order needs to be expedited, it is also accommodated
in the production plan.

Copy of this updated monthly plan is sent to the Head (Purchase & Stores) for synchronizing the procurement
activities.

b) Infrastructure and Environment

Our organization has already identified and provided the required infrastructure and environment for the
operation of processes.

The equipment and environment required for performing production jobs is mentioned in the respective work
instructions.

The Head (Production) ensures that it is strictly followed.

Production equipment are kept in good condition by suitable repairs / maintenance as per the ‘Procedure for
Maintenance Management (COMP-MTP-01)’.

c) Monitoring and Measuring Resources

The Head (Production) coordinates with the Head (Quality) to ensure the availability and use of suitable
monitoring and measuring resources such as calibrated multi-meters, ohm meters, etc. for use by the production
workers.

d) Appointment of Competent Persons

The Head (Production) coordinates with the Head (P&A) to ensure the deployment of competent persons for
production activities, including any required qualification (such as certification for welders).

Prepared by Reviewed & Approved by Issued by Doc. Control

Doc ID: COMP-OPP-01
Signature Version: 001
Date 01-Oct-2015 01-Oct-2015 01-Oct-2015 Effective date: 01-Oct-2015
Designation QMR MD QMR Page 2 of 4
 ABC COMPANY LIMITED
QUALITY MANAGEMENT SYSTEM MANUAL
PROCEDURE FOR CONTROL AND VALIDATION OF PRODUCTION

e) Prevention of Human Error

The Head (Production) coordinates with the Head (Quality) and Head (P&A) to ensure that appropriate actions
are taken to prevent human errors. Actions include the design of jigs and fixtures, colour-coding of parts and
wires, use of anti-static wrist bands, graphic display of work instructions / Dos and Don’ts at work stations, etc.,
and, provision of appropriate training to the workers on the use of defect-prevention tools and prevention of
human errors.

f) Performance of Production Jobs

The production department identifies reference standards and codes for production activities (if any), and
complies with the applicable standard/code.

Production is carried out according to the documented work instructions.

Heat sink making is carried out according to work instruction COMP-OPP-01-W01.

UPS assembly is carried out according to work instruction COMP-OPP-01-W02.

Inverter assembly is carried out according to work instruction COMP-OPP-01-W03.

Criteria for acceptance of workmanship are clearly defined. For jobs such as soldering, heat sink cutting, UPS /
Inverter wiring and UPS / Inverter fitting, the acceptable and non-acceptable jobs are illustrated through colour
photographs displayed at the workstations.

g) Stage-wise Quality Inspections / Tests and Product Release

Product characteristics and process parameters that are indicative of the product / process have already been
identified. These are monitored and measured.

The Head (Production) coordinates with the Head (Quality) to ensure the implementation of monitoring and
measurement activities at appropriate stages (as per Quality Plan) to verify that criteria for control of processes
or outputs, and acceptance criteria for products have been met.

h) Validation of Processes

Certain production process like welding requires validation and periodic revalidation, of its ability to achieve
planned results, where the resulting output cannot be verified by subsequent monitoring or measurement.

Method of process validation / revalidation is mentioned in the respective work instruction.

i) Delivery and Post-delivery activities

The final products (UPS / Inverters) are packed properly and delivered to the dealer / customer by suitable
means. The Head (Production) looks after the packing and transportation activities.

Prepared by Reviewed & Approved by Issued by Doc. Control

Doc ID: COMP-OPP-01
Signature Version: 001
Date 01-Oct-2015 01-Oct-2015 01-Oct-2015 Effective date: 01-Oct-2015
Designation QMR MD QMR Page 3 of 4
 ABC COMPANY LIMITED
QUALITY MANAGEMENT SYSTEM MANUAL
PROCEDURE FOR CONTROL AND VALIDATION OF PRODUCTION

Post-delivery activities such as on-site product installation, warranty / AMC support, etc. are looked after by the
Head (Service) according to the ‘Procedure for Control and Validation of Service (QMR-Q-M-PR-11).

7. RECORDS:

The following record(s) are maintained.

Sl. Retention Custodian(s)

No. Record Title / ID Format Medium Period
1 Monthly Production Plan English, Text Electronic Min 3 years Head
(Word file) (Production)

8. DOCUMENT AMENDMENT HISTORY:

Version No. Summary of changes from previous version of the document Changes sought by Remarks of QMR
V-001 First version released for implementation. N/A Nil

Prepared by Reviewed & Approved by Issued by Doc. Control

Doc ID: COMP-OPP-01
Signature Version: 001
Date 01-Oct-2015 01-Oct-2015 01-Oct-2015 Effective date: 01-Oct-2015
Designation QMR MD QMR Page 4 of 4