Document No.

FPC/01/CS
FACTORY PRODUCTION CONTROL BASED ON ISO 9001 Issue No. 01
STANDARD COVERING THE PRODUCTION LINE
Date 01-03-2020

1. General

This annex specifies the requirements for the Factory Production Control (hereafter FPC)

and the quality management system covering the production line of collectors.

2. Organisation

2.1General
The FPC shall be operated according to a documented quality system. The manufacturer

shall establish, document and maintain the FPC system to ensure that the products placed

on the market comply with the declared performance of the characteristics. The records must

be kept at least for a period of 3 years. All quality documentation shall be kept up to date.

2.2Responsibility and authority

The responsibility, authority, and the interrelationships between all personnel who manage,

perform, or verify work affecting quality or product conformity, shall be defined. This applies

particularly to personnel who need the organizational freedom and authority to:

a) Identify procedures to demonstrate conformity of the product at appropriate stages

b) Initiate action to prevent the use and production of non-conforming product

c) Identify and record any product quality problems or non-conformities

2.3Management representative for the FPC

At every place of production, a representative with the appropriate knowledge and production

experience shall be appointed by the manufacturer and given responsibility for managing and

supervising of the FPC procedures and for ensuring that the requirements of this annex are

implemented and maintained.

 Document No. FPC/01/CS
FACTORY PRODUCTION CONTROL BASED ON ISO 9001 Issue No. 01
STANDARD COVERING THE PRODUCTION LINE
Date 01-03-2020

2.4Quality Objectives
Top management shall ensure that quality objectives regarding the production process are

established at relevant functions and levels within the organization. The quality objectives

shall be measurable

There shall be at least one quality objective every year.

2.5Management review
Management shall review at least every year the FPC system to ensure its continuing

suitability, adequacy and effectiveness. Records of such reviews shall be maintained. The

minimum input for management review shall be at least related to the conformity of the

product and include the following:

a) Status of corrective and preventive actions

b) Status of complains

c) Follow up from previous management reviews

d) Follow up of quality objectives

e) Results of audits

2.6Training of personnel
The manufacturer shall establish and maintain procedures for the training (with a training

plan and training records) of all personnel in activities affecting quality or product conformity.

Personnel performing work affecting product conformity shall be qualified on the basis of

appropriate education, training and/or experience, as required.

 Document No. FPC/01/CS
FACTORY PRODUCTION CONTROL BASED ON ISO 9001 Issue No. 01
STANDARD COVERING THE PRODUCTION LINE
Date 01-03-2020

3. Quality Documentation
The manufacturer’s documentation and procedures shall be relevant or appropriate to the

production and process control used during manufacture of the product, and shall provide at

least the following items:

a) Quality aims or policy, the organizational structure, responsibilities and authority of

the management with regard to product conformity;

b) Procedures for specifying and verifying the raw materials and other constituent

materials;

c) Manufacturer’s production control and other techniques, processes and systematic

actions that will be used;

d) Inspections and tests to be carried out before, during and after manufacture,

together with their frequency and possible retest procedures;

e) Procedures for handling, storage, packaging, marking and labelling the product;

f) Procedures for all personnel to receive training in the activities affecting quality or

conformity of the product

g) A procedure that will specify how non-complying products shall be dealt with. Any

event of this kind shall be recorded as they occur and these records shall be kept

for the period defined in the manufacturer’s written procedures.

h) A procedure for corrective actions that instigates action to eliminate the cause of

non-conformities in order to prevent recurrence.

i) A procedure shall be established to define the responsibilities and requirements for

planning and conducting internal audits, establishing records and reporting

results(see exclusion for very small companies in chapter 8)

j) The manufacturer shall have written procedures ensuring that processes related to

affixing traceability codes and/or markings are inspected regularly.

k) A procedure for control over documentation that affects the FPC

 Document No. FPC/01/CS
FACTORY PRODUCTION CONTROL BASED ON ISO 9001 Issue No. 01
STANDARD COVERING THE PRODUCTION LINE
Date 01-03-2020

4. Inspection and testing

4.1General

All necessary facilities, equipment and personnel shall be available to carry out the

inspections and tests. The manufacturer may employ, under contract, a subcontractor who

has the facilities, equipment and personnel to carry out the inspection and tests on behalf of

the manufacturer. The manufacturer shall be responsible for control, calibration, and

maintenance of testing, measuring, and inspection equipment, whether owned by or on loan

to the manufacturer or a subcontractor.

Inspection and testing shall be performed by personnel qualified for such tasks on the basis

of documented appropriate education, training and/or experience.

4.2Test equipment
Tests to demonstrate conformity of the finished product to the relevant product standard shall

be performed using appropriate testing equipment and documented working instructions.

The test equipment shall be controlled regularly by calibration or verification following the

manufacturer’s own instructions.

4.3Inspection and testing of raw materials and other constituent materials

The manufacturer shall ensure that raw materials and other constituent materials conform to

his specified requirements. In determining the checks necessary consideration shall be given

to the control exercised by the supplier and the documented evidence of conformity supplied

(often referred to as supplier certified components or certified raw materials). There should

be a proper traceability to the supplier’s documentation.

This table shows the minimum checks to be carried out on incoming goods. All checks and tests shall
be recorded:
 Document No. FPC/01/CS
FACTORY PRODUCTION CONTROL BASED ON ISO 9001 Issue No. 01
STANDARD COVERING THE PRODUCTION LINE
Date 01-03-2020

4.4 Inspection and testing during manufacture and on finished product

In order to manufacture products which conform to the product standard the manufacturer

shall control his process and perform inspection and tests as described in his manual, and

complying at least with the following table.

4.5 Inspection and test records

The results of products inspection and testing shall be recorded

The record shall contain the product identification, the date and time of manufacture and for

each property the test methods, the test results, the inspection result and the identification of

the person carrying out the inspection.

5. Actions in the case of non-conforming products

If the result of a test or the inspection of a product is a failure, the manufacturer shall

immediately take the steps necessary to rectify the deficiency. Products which do not

conform to the requirements of the product standard, shall be marked, isolated or controlled

accordingly. When the deficiency has been identified and rectified, the test or inspection in

question shall be repeated without delay accordingly to the quality documentation, to provide

the evidence that the defects have been overcome. Corrective and preventive actions taken

in case of non-conforming products shall be documented.

6. Handling, storage, packaging and marking of products

In accordance with the quality documentation the manufacturer shall:

a) Provide methods of handling that prevent damage or deterioration;

b) Provide suitable storage areas or stock rooms or prevent damage or deterioration of

 Document No. FPC/01/CS
FACTORY PRODUCTION CONTROL BASED ON ISO 9001 Issue No. 01
STANDARD COVERING THE PRODUCTION LINE
Date 01-03-2020

the product;

c) Control the packaging, storage and the marking processes

7. Traceability of products
Individual collectors and their main components shall be identifiable and traceable with

regard to their production origin.

8. Internal audit
This clause is not mandatory for very small companies that do not have the resources to

audit themselves. However this exclusion must be documented and explained in the Quality

Documentation of the company. A very small company is defined as having less than10

people involved in the FPC and less than 3 levels of hierarchy.

The organization shall conduct internal audits at planned intervals of at least once a year to

determine whether the quality management system

a) Conforms to the quality documentation

b) Is effectively implemented and maintained

In case of internal audit, an audit programme shall be planned, taking into consideration the

status and importance of the processes and areas to be audited, as well as the results of

previous audits. The audit criteria, scope, frequency and methods shall be defined. The

selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit

process. Auditors shall not audit their own work.

A document procedure shall be established to define the responsibilities and requirements for

planning and conducting audits, establishing records and reporting results.

Records of the audits and their results shall be maintained.

The management responsible for the area being audited shall ensure that any necessary

corrections and corrective actions are taken without undue delay to eliminate detected
 Document No. FPC/01/CS
FACTORY PRODUCTION CONTROL BASED ON ISO 9001 Issue No. 01
STANDARD COVERING THE PRODUCTION LINE
Date 01-03-2020

nonconformities and their causes.

Follow up activities shall include the verification of the actions taken and the reporting of

verification results.