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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)

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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.
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Certificate of Conformity for parts of EN 54 (Fire
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Clause Activity Requirements
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
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Clause Activity Requirements
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 products
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 manufacturers 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.
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Clause Activity Requirements
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 manufacturers 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:
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Clause Activity Requirements
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.
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Certificate of Conformity for parts of EN 54 (Fire
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Clause Activity Requirements
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;
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Clause Activity Requirements
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.
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Certificate of Conformity for parts of EN 54 (Fire
detection and alarm systems products)

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Clause Activity Requirements
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.
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Date: 29 March 2010
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Certificate of Conformity for parts of EN 54 (Fire
detection and alarm systems products)

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Clause Activity Requirements
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.

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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