PN_218

Doc No: PN218

PUBLICATIONS Revision No: 1

Date: 29 March 2010 Factory Production Control Requirements (FPC) for EC Certificate of Conformity for parts of EN 54 (Fire

detection and alarm systems products)

Page: 1 of 10

© BRE Global Ltd 2010

Introduction

1. The requirements of this document supplement the Factory Production Control requirements given in Table 1 of PN111 by giving the specific requirements for Factory Production Control (FPC) for fire detection and alarm systems products as specified in the harmonized standards of EN 54 Annex ZA. The specific requirements are detailed in Table 1 of this document.

2. This document must be read in conjunction with PN 111A.

3. The manufacturer is required to establish and maintain a FPC system to ensure that the products placed on the market conform to the stated performance characteristics and the samples subjected to type testing.

Table 1: FPC requirements as specified in Annex ZA of EN 54 standards

Clause Activity Requirements

1. Review of Company details/ Responsibility

Responsibility and authority and management representation

Top management shall ensure that responsibilities and authorities are defined and communicated within the organization.

Top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes:-

• ensuring that processes needed for the quality management system are established, implemented and maintained,

• reporting to top management on the performance of the quality management system and any need for improvement, and

• ensuring the promotion of awareness of customer requirements throughout the organization.

Management commitments

The management shall provide evidence of its commitment to the development and implementation of the QMS by ensuring adequate availability of resources to ensure the continuous improvement and effectiveness of the system.

Resources

The organisation shall determine and provide the resources needed to –

• implement and maintain the quality management system and continually improve its effectiveness; and

• enhance customer satisfaction by meeting customer requirements.

Doc No: PN218




Page: 2 of 10



2. Review of Quality Management System / Quality Plan

Quality Manual

The manufacturer shall establish and maintain a quality manual that includes;

• reference to the documented procedures established for the quality management system.

• a description of the interaction between the processes of the quality management system.

3. Action taken to resolve previous non-conformities

Review of previous non-compliance

A review of any previous non-conformities shall be carried out to ensure that the appropriate corrective and preventative actions have been taken and have been satisfactorily completed and implemented.

4. Internal Review This requirement is not applicable to Annex ZA.

5. Document Control Control of documents

The manufacturer shall have a documented procedure which defines the controls needed to:

• approve and re-approve documents for adequacy prior to issue,

• ensure that changes and the current revision status of documents are identified,

• ensure that documents are readily identified with the relevant versions of the applicable documents are available at the points of use,

• ensure that documents of external origin are identified and their distribution controlled, and

• prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.

6. Customer requirements and contracts

This requirement is not applicable to Annex ZA.

7. Purchasing Purchasing:

The company shall identify the purchasing requirements for the controls required for the purchase of specific components/parts for use in a specific product. The company shall establish a list of suppliers identifying their name, address, and the components/parts, products, materials and/or services they have been authorised to supply.

The type and extent of the controls applied to the supplier and the purchased items shall be identified and shall continue to be assessed. Records of the results of assessment and any necessary actions arising

Doc No: PN218




Page: 3 of 10



from the assessment shall be maintained.

The company is required to produce a list of components critical to the operation of each product. This list shall include all components used within the manufacture of the product that if changed could alter or prevent compliance to the requirements of the relevant product standard.

The critical component list will be reviewed agreed by LPCB at the initial assessment to ensure that all components critical to the product’s operation have been included.

The following information needs to be recorded for each component identified as ‘critical’:

• Component name,

• Part Number and

• Manufacturer.

(See Appendix 1 of this document, ‘Critical’ components list form).

The company shall have a documented procedure to ensure that ‘critical’ components are not changed without first informing the LPCB / BRE global

Subcontracting

Where subcontracting exists then the manufacturer shall retain the overall control of the product and shall ensure that all received information that is necessary to fulfil the manufacturer’s responsibilities is in accordance with the European standard in question.

If the manufacturer has part of the product designed, manufactured, assembled, packed, processed and/or labelled by subcontracting, a FPC inspection of the subcontractor may also be carried out for that specific product where appropriate.

The manufacturer who subcontracts all of his activities may in no circumstances pass these responsibilities on to the subcontractor.

The responsibilities of placing a product onto the market shall be clearly defined.

8. Review of Product Specification

Modification

A product specification assessment shall be carryout by comparing the LPCB document register against the current build status.

The company shall document a procedure which deals with modification.

If modifications are made to the product, production process or factory production control system that could affect the compliance of the product against the specified requirements e.g. EN 54 standards, then the company shall:-

• notify LPCB detailing the changes on LPCB modification form 318.

• carry out their own validation and verification to ensure that the product continues to comply with the requirements of the appropriate standard.

Doc No: PN218




Page: 4 of 10



Modification can be defined into 4 different categories as follow:-

• Category 1: Small changes to the documents or production processes that do not affect the form or function of the product.

• Category 2: Minor changes that may affect the form of the product but that can have no significant effect on the function or performance of the product, or compliance with the relevant standards or test procedures.

• Category 3: Minor changes that may affect the form of the product where it is uncertain that the function or performance of the product, or compliance with the relevant standards or test procedures is unaffected, without some further investigation or analysis.

• Category 4: Changes that may affect the form or function of the product where it is possible or likely that the performance of the product or compliance with the relevant standards or test procedures may be affected.

(Please refer to PN142 for examples and guidance only)

Where there is an agreement in place between LPCB and the company responsible for the product build status, then the company can adopt the accelerated modification guideline PN142. The company shall have a nominated person(s) who notify the LPCB of the modification using the LPCB modification form 318.

For modifications classified as Category 1 or 2, the notified person(s) may authorise the implementation of the modification, in accordance with the manufacturer’s quality management procedures. The documentation of the modification and the record of the classification and authorisation shall be held by the manufacturer and made available to the LPCB assessor for inspection and assessment.

For modifications classified as Category 3 or 4, an application should be made to LPCB with the documentation of the modification and the record of the category, along with form 318. LPCB will then assess if any testing is necessary. If no testing is necessary (which should normally be the case for Category 3 modifications), then authorisation for the modification will be given by LPCB after the satisfactory assessment of the documentation submitted. If testing is required then a test schedule will be generated and authorisation for the approval will be given on the satisfactory completion of the tests. The costs of dealing with Category 3 or 4 modifications will depend on the time required for the assessment and the testing necessary.

(Please refer to PN142)

9. Production Planning of product realisation

The company shall plan and develop the processes needed for product realization and providing the resources to ensure that product meet the specified requirements.

For each product/model, a fully documented manufacturing process is required which reference in a systematic manner to the following:

Doc No: PN218




Page: 5 of 10



• applicable procedures,

• work instructions,

• verification, validation, monitoring, inspection and test specific to the product throughout the various process including goods-in, in process, final testing and authorisation to release the product.

Records shall be made available to show evidence that the production has been sampled and tested. These records shall clearly indicate the production has been successful and they meet the defined acceptance criteria. These records shall be available for at least 10 years and indicate that they have been passes/authorised by the person responsible for the control/test.

10. Action on Non-conforming Material

Control of non-conforming products

The company shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery.

The controls and related responsibilities and authorities for dealing with nonconforming product shall be defined in a documented procedure.

The company shall take the appropriate actions when there is a nonconforming product to ensure that the product either meets the applicable requirements of the relevant standard or eliminated.

When a nonconforming product is corrected it shall be subject to re-verification to demonstrate conformity to the applicable requirements.

11. Inspection and in process testing

Monitoring and measurement of processes and product

All processes are required to be monitored and measured where applicable to ensure that production maintain its planned results. When planned results are not achieved, correction and corrective action shall be taken, as appropriate, to ensure conformity of the product.

At appropriate and predefined stages of the product realisation, the manufacturer is required to monitor and measure the characteristics of the product to ensure that the manufactured product will and continue to conform to the appropriate specified requirements.

Evidence of product conformance shall be kept which identify the acceptance criteria and the authority of releasing the verified product.

Product release and service delivery shall not proceed until the planned arrangements have been satisfactorily completed.

Doc No: PN218




Page: 6 of 10



12. Equipment Control of monitoring and measuring devices

The company shall ensure that measuring equipment used for monitoring and measurement is calibrated such that the manufactured product is always conforming.

The measuring equipments shall be:

• calibrated or verified at specified intervals or prior to use,

• adjusted or re-adjusted when necessary;

• Identified with their calibration status

• Protected from damage or deterioration during use or storage.

The calibration records shall be kept to assess whether previously measured results are valid. The company is required to take appropriate action when the equipments are found to be out of calibration.

13. Storage, handling, packaging and transportation

Refer to clause 9

14. Certification Marks

Certification mark

The CE-marking symbol shall be placed on the product and be accompanied by the number of the EC certificate of conformity and the notified body number.

The CE marking symbol shall be shown on the accompanying commercial documentation supplemented by:

1. the identification number of the notified product certificate body

2. the name or identifying mark and registered address of the manufacturer

3. the last two digits if the year in which the marking was affixed

4. the number of the EC certificate of conformity

5. the reference to the applicable standard e.g. EN 54-7

6. the description of the construction product (i.e. ionisation smoke detector )

7. the type/model designation of the product h) the data required by the applicable standard or reference to a document, which shall be uniquely identifiable and available from the manufacturer, containing these data.

EC certificate and declaration of conformity

The manufacturer, or his agent established in the EEA, shall prepare and retain a declaration of conformity, which authorizes the affixing of the CE marking. This declaration shall include:

• the name and address of the manufacturer, or his authorized representative established in the EEA, and the place of production;

Doc No: PN218




Page: 7 of 10



• the description of the construction product (e.g. Point smoke detectors for fire detection and fire alarm systems for buildings);

• the type/model designation of the product; the provisions to which the product conforms (e.g. annex ZA of this EN); -any particular conditions applicable to the use of the product (if necessary);

• the name and address (or identification number) of the Notified Product Certification Body;

• the name of and position held by the person empowered to sign the declaration on behalf of the manufacturer or of his authorized representative.

The declaration shall contain a certificate of conformity with the following information:

• the name and address of the Notified Product Certification Body;

• the certificate number;

• the name and address of the manufacturer, or his authorized representative established in the EEA;

• the description of the construction product (e.g. Point smoke detectors for fire detection and fire alarm systems for buildings);

• the type/model designation of the product;

• the provisions to which the product conforms (e.g. annex ZA of this EN);

• any particular conditions applicable to the use of the product (if necessary);

• any conditions and period of validity of the certificate, where applicable;

• the name of and position held by the person empowered to sign the certificate.

The above mentioned declaration and certificate shall be presented (if requested) in the official language or languages of the Member State in which the product is to be used.

15. Records Control of records

The manufacturer records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records.

Doc No: PN218




Page: 8 of 10



16. Complaints Customer feedback / complaints

The organisation shall determine and implement effective arrangements for communicating with customers especially customer feedback, including customer complaints.

The company shall keep a log/register of any complaint received and corrective and preventative actions are carried out satisfactory. All complaints must be dealt with in a timely and effective manner.

17. Corrective / Preventive action

Corrective and preventative action

The company shall establish a documented procedure to define requirements for identifying, correcting, preventing, and recording nonconforming product or parts of product.

Corrective actions shall be appropriate to the effects of the nonconformities encountered.

The company shall take action to correct any nonconforming product or parts of product and eliminate the cause of nonconformities in order to prevent recurrence.

18. Training and competence

Competence and training

The company shall:

• determine the necessary competence for personnel performing work affecting product quality,

• provide training or take other actions to satisfy these needs,

• evaluate the effectiveness of the actions taken,

• ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and

• maintain appropriate records of education, training, skills and experience.

19. Audit testing Company Internal Product Audit

Internal product audits shall be conducted on finished samples taken from the production line and are tested and verified independently from the production line testing. The product audit shall include verification of the following where applicable:

• build standard,

• labelling,

• Installation instructions,

• Technical manuals such as Operation and commissioning manuals performance, e.g. sensitivity, classification, sound levels, operation performance.

Doc No: PN218




Page: 9 of 10



• Manufacturing records

• Manufacturing process

The independent testing records shall be reviewed to determine that production samples still correspond with the approved samples submitted for type testing. Where the product fails to satisfy the acceptance measures, corrective actions shall be taken immediately and the products or batches not conforming shall be isolated and identified accordingly. (refer to clause 16).

The extent and frequency of the product audits is determined by the company. As a guideline it is recommended that a product audit is conducted on each individual product at least annually.

The test procedures/ requirements shall be reviewed as part of the audit to review inspection criteria.

Doc No: PN218




Page: 10 of 10


Appendix 1: Critical Component List

Critical Component List

Company responsible for build standard of product

Product identification Name/reference No.

Component name, Part Number Manufacturer

PN_218

Documents

Transcript of PN_218