PD CIG 024 - May 2014

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PERMANENT DOCUMENT
CIG 024
Factory Inspection Procedures
Guidance to Certification Bodies, Inspectors,
Manufacturers and Licence Holders
WARNING:
THIS DOCUMENT IS ONLY VALID IF USED BY ECS MEMBERS
AND THEIR AUTHORISED AGENTS
Approved by:
Date of issue:
Supersedes:
ECS General Meeting 8-9 April 2014
May 2014
PD CIG 024 – May 2009
No. of pages: 18
Page 1 of 18
EEPCA, the European Electrical Products Certification Association
17, rue de l’Amiral Hamelin, F-75783 Paris Cedex 16 – Tel: +33 140373563 – Email: [email protected]
Document issued and distributed by EEPCA
© EEPCA 2014 – all rights reserved
THE CONDUCT OF FACTORY INSPECTIONS
INTRODUCTION
This document has been produced to provide help and guidance to Certification Bodies,
Inspectors, Manufacturers and Licence Holders on how Factory Inspections are conducted.
Under the CCA procedures, irrespective of which Certification Body undertakes the inspection,
the procedures whereby Certification Bodies have factories inspected and Inspectors
undertake this inspection are the same throughout CCA.
The document has been divided into four parts:
Part I:
Advice to the Licence Holders and Manufacturers
Part II:
Part II-1: Guidance to Licence Holders on completing Form PD CIG 022:
Questionnaire Section B.1
Part III:
Part IV:
Part II-2: Guidance to Manufacturers on completing Form PD CIG 022:
Questionnaire Section B.2
Guidance to Certification Bodies on completing Form PD CIG 022
Section A: Request of Inspection
Guidance for Inspectors undertaking Factory Inspections and completing form PD
CIG 023 Factory Inspection Report
Parts I and II are of immediate concern to Manufacturers and Licence Holders, since they offer
advice and guidance on actions which the Manufacturers/Licence Holders shall take.
Parts III and IV are for Certification Bodies. However, they may be sent to the Licence Holder
and/or the Manufacturer on request to inform them of the instructions given to Factory
Inspectors so that the Licence Holder and/or the Manufacturer understands what the Inspector
is looking for during the inspection.
Clarification:
Part I
This gives general advice and information to the Licence Holder and the Manufacturer
on the overall procedures for Factory Inspections.
Part II
This gives information to the Licence Holder and the Manufacturer on how to complete
PD CIG 022 Section B.
When a Licence Holder advices a Certification Body that he intends to have a certified
product manufactured in a factory that has not previously been inspected, the document
PD CIG 022 Section B: Questionnaire needs to be completed.
The Certification Body processing the approval application is responsible for ensuring
that it attaches a copy of the PD CIG 024 (at least Part II-1 and Part II-2) to each PD CIG
022 Section B: Questionnaire sent.
The Licence Holder needs to answer the questions in Section B.1 and forward the
Section B.2 to his Manufacturer for completion.
For each individual Manufacturer a separate questionnaire shall be filled.
As the whole of the factory inspection system depends upon this initial Questionnaire
being completed fully and accurately, much time can be saved by the Licence Holder,
the Manufacturer and the Certification Body, if this form is filled in correctly the first time
and returned promptly to the requesting Certification Body.
Part III
It is the common policy that the Factory Inspection is conducted by the Inspection
Body in the country in which the Manufacturer's premises are located. Part III describes
the document used by the Certification Body to request the Inspection Body in another
country to perform an inspection of a factory location on its behalf. This part is primarily
the concern of Certification Bodies.
Part IV
This part gives instruction to Inspectors. It gives detailed information on what the
Inspector should be looking for and how he is to make the assessment. The aim of Part
IV is to ensure that, irrespective of which Inspection Body conducts the Inspection, the
same criteria are used to assess whether the Manufacturer's premises meet the
Minimum Harmonised Requirements set down by the PD CIG 021.
PD CIG 024 - May 2014
page 2 of 18
FACTORY INSPECTIONS
Part I: Advice to Licence Holders and Manufacturers
INTRODUCTION
The following instructions have been established to help Licence Holders and
Manufacturers understand and correctly interpret the basic requirements of Certification
Bodies when preparing for inspection.
CONDUCT OF THE INSPECTION
The inspection will be conducted during normal working hours.
The Manufacturer's representative or his deputy should be available within a reasonable
time after being contacted from reception.
The Certification Body, and hence the Inspector, is to be given full access to the
Manufacturer's premises so that compliance with the requirements of the PD CIG 021 can
be verified.
Also the Manufacturer shall give full co-operation throughout the inspection.
Any unwarranted or personal criticism or lack of co-operation by the Manufacturer may be
reported to the requesting Certification Body(ies).
Inspectors will be aware that they are at all times acting as representative of the
requesting Certification Body(ies) and they, in their turn, are expected to behave accordingly.
At the end of the inspection, it will be helpful that the Inspector be given an appropriate
place where he can complete his inspection report, since he is requested to complete the
report and hand a copy thereof to the Manufacturer's representative before he leaves the
factory.
INSPECTOR’S RESPONSIBILITIES
The Inspector shall establish that the Manufacturer keeps and has in operation a quality
system, which guarantees that products leaving the factory are at all times complying with
the relevant requirements.
In order to be able to verify the Manufacturer's ability to comply, it is essential that the
Inspector visit all areas necessary (such as receiving, in-process and final inspection, and
laboratories etc.). When planning and conducting such an inspection, the Inspector has to
have allocated enough time so as to be able to conduct a thorough job.
Special care as to testing and record keeping will be taken where product or parts thereof
have been manufactured or assembled at Subcontractors or Out-Workers.
It is emphasised that confidentiality of all information gathered at a Manufacturer's plant
shall be maintained.
In the event that a Manufacturer is producing products for more than one Licence Holder and
an Inspector’s finding does not apply to all Licence Holders a separate PD CIG 023
Inspection Report is to be completed for each Licence Holder individually.
SCHEDULING INSPECTIONS
The frequency and period of inspection visits are, as far as possible, scheduled in
accordance with the wishes of the requesting Certification Body(ies).
Pre-Licence inspections shall be announced and arranged with the Manufacturer in
order to assure that all persons involved can be available.
Routine inspections are normally un-announced. However in certain cases, it might be
necessary to meet the right contact person. In such circumstances, an inspection visit may
need to be pre-announced. On the other hand, due to a specific situation with a
Manufacturer, an inspection may need to be imperatively carried out un-announced.
It is the Certification Body who has to decide in this respect.
PD CIG 024 - May 2014
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FACTORY INSPECTIONS
Part II-1: Guidance to Licence Holder on completing
form PD CIG 022: Questionnaire Section B.1
NOTE:
The “Factory Inspection Procedures  Harmonized Requirements” are referred to as PD CIG 021 in this
document.
Section B.1 shall be filled out by the Licence Holder.
The completed questionnaire has to be returned to the requesting Certification Body
before the Pre-Licence inspection may be scheduled.
Complete and accurate information will enable a proper evaluation to be carried out and thus
avoid a possible repetition of the Pre-Licence inspection, additional costs and a delay in
granting the Certification Mark.
B.1.1
The Licence Holder is the company who signs the certification agreement with the
Certification Body. The Licence Holder may be different from the Manufacturer.
The Licence Holder’s representative is the key-person having the contacts with the
Certification Body.
B.1.2
List the kind of product (family name, e.g. vacuum cleaner), all brand and/or trade
names and type references/model designations of the product(s) intended to be
marked with the Certification Mark.
B.1.3
Enter all the Certification Mark(s) intended to be applied on the products and other
requested information if available.
B.1.4
The purpose of this item is to demonstrate in which way it is assured that
constructional changes of the certified product will be made only after approval by
the Certification Body.
1)
Self-explanatory
2)
Self-explanatory
3)
‘YES’, if the Licence Holder is responsible for the production quality system at
the manufacturing site.
‘NO’, if the manufacturing site is producing according its own quality system,
even when the Licence Holder verifies the functioning of this quality system.
4)
‘YES’, if the Licence Holder has a contract with the manufacturing site that (at
least) covers the items 1), 2) and 3) above.
‘NO’, if there is no contract covering the items 1), 2) and 3) above.
Also ‘NO’, if the manufacturing site belongs to the same company as the
Licence Holder. In this case it should be stated that the manufacturing site and
the Licence Holder belong to the same company.
NOTE:
Where this paragraph refers to a quality system, this quality system might be but does not need
to be a certified quality system.
B.1.5
Section B.1 of this document shall be verified and signed by an authorised
management representative of the Licence Holder.
PD CIG 024 - May 2014
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FACTORY INSPECTIONS
Part II-2: Guidance to Manufacturer on completing
form PD CIG 022: Questionnaire Section B.2
NOTE:
The “Factory Inspection Procedures  Harmonized Requirements” are referred to as PD CIG 021 in this
document.
Section B.2 shall be answered by the Manufacturer.
The completed questionnaire has to be returned to the requesting Certification Body
before the Pre-Licence inspection may be scheduled.
Complete and accurate information will enable a proper evaluation to be carried out and thus
avoid a possible repetition of the Pre-Licence inspection, additional costs and a delay in
granting the Certification Mark.
B.2.1
Actual factory location and geographical (street) address.
Please also provide local street map or sketch, best mode of transportation,
parking facilities etc.
B.2.2
The contact person is the key-person to guide the Inspector through the factory.
The contact person shall be familiar of the quality system and product certification
requirements, and have full access to all relevant information and facilities.
It is necessary that at least one deputy contact person be nominated. A deputy
contact person shall be available in case of absence of the contact person.
The management representative is the person at the Manufacturer responsible for
the certified product. This may or may not be the contact person.
B.2.3
Self-explanatory
B.2.4
Give the total number of employees including temporary workers in the company.
Provide also the number of employees engaged in the production of certified
products. Approximate numbers will do.
NOTE:
This information is useful in order to enable the Inspection Body to estimate the time necessary
for carrying out the inspection.
B.2.5
Specify the materials, components and sub-assemblies which are critical/have a
safety implication on the finished product:
– specify the supplier(s) of these materials and/or components,
– indicate which components are certified and bear which Certification Mark(s),
– specify which sub-assemblies are received from which sub-contractor(s).
B.2.6
Complete and accurate information is needed for all products intended to be
certified.
This is to allow the Inspector to satisfy himself with the Manufacturer’s quality
system, as:
a) if written or documented procedures exists, it may prove helpful to attach
copies of the relevant procedures.
b) if no written or documented procedures exists, or cannot be made available to
the requesting Certification Body, then the various stages of control, inspection
and testing shall be described in chronological order.

Information should be detailed under the following headings:
 Incoming Inspection and Testing
describe visual checks, tests, sampling procedures, acceptance criteria and/or
all other verification methods (e.g. Certificate of Conformity).
PD CIG 024 - May 2014
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

 In Process Inspection and Testing:
same as above, indicate whether the inspections and tests are 100 % production
line tests and/or random inspections and tests.
 Routine Tests (Cl. 5.3 of PD CIG 021):
Specify the type of test, the test frequency, the applied test values, the tripping
limit (= the max. and/or min. value) and testing time.
A typical example for routine tests for a microwave oven might be:
Earth continuity
Insulation resistance
Dielectric strength
Input power
Microwave leakage
100 %
100 %
2%
1/batch
100 %
25 A a.c.
500 V d.c.
1375 V a.c.
230 V a.c.
mains supply
R<0,1 ohm
R>2 Mohm
0,3 < I < 5 mA
1375 W <P<1450 W
< = 3 mW/cm2
3s
3s
2s
N/A
5s
 Product Verification Tests/Periodic Tests (PVT) (Cl. 5.8 of PD CIG 021):
State which additional tests are performed on samples randomly selected from
the production and/or stock, to verify the quality of the product and compliance
with the certification standard.
Specify the sampling rate, the type of test(s) performed (including the applied test
values, tripping limit and test time) and the location where these tests are
performed.
B.2.7
As far as applicable, specify by which other Certification Body(ies) the product has
already been certified/which other certification marks are already applied to the
product. State ‘None’ if no other product certifications for the product(s) to be
certified exist.
NOTE:
This questionnaire is used for preparation/organisation of a Pre-Licence Inspection. It might be that
this Pre-Licence Inspection can be waived, based on already existing certification of the product.
B.2.8
Details shall include type of standard, scope, name of certifier and expiry date of
certificate or provide a copy of appropriate certificate.
B.2.9
Self-explanatory
B.2.10
Section B.2 of this document shall be verified and signed by an authorised
management representative at the factory where the product is or will be
produced.
PD CIG 024 - May 2014
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FACTORY INSPECTIONS
Part III: Guidance to Certification Bodies on completing
form PD CIG 022: Questionnaire Section A
Completion of Section A is the responsibility of the requesting Certification Body.
A.1
Name of Certification Body requesting the inspection and it’s file reference
number.
A.2
Name of Certification Body, Inspection Body or Authorised Agent requested to
perform the inspection.
A.3
Actual factory location and geographical (street) address. Include name and
function of contact person as given in PD CIG 022, Section B.2, items B.2.1 and
B.2.2
A.4
Licence Holder name and address
A.5
Use the product category abbreviation as commonly used within CCA.
NOTE:
Current list of abbreviations of Product Categories can be found under the following path:
www.eepca.eu  Document Server  OSM-FIP Public Documents  Decisions.
Also give the product type, name and indicate type number or family series as
practical.
A.6
Make reference to applicable standards: EN, HD, IEC or national standards.
A.7
Define clearly which Certification Mark or attach reference copy of mark. Refer to
PD CIG 022, Section B.1, item B.1.3.
A.8
Provide number of Routine Inspections per year after the certification has been
granted.
For Routine Inspections separate orders are to be issued.
A.9
Make reference to applicable documents or document list.
Under “other information” details are to be given regarding:
– test requirements;
– test equipment;
– sample selection;
– shipping instructions;
– billing instructions.
A copy of the completed PD CIG 022 Section B.1 and B.2 is to be attached to this PD
CIG 022, Section A. If for special reasons the requesting Certification Body cannot provide
the questionnaire PD CIG 022 Section B.1 and/or B.2, specify reason and give special
instructions.
Enter date of issue of request.
The authorised representative of the requesting Certification Body shall sign this document.
PD CIG 024 - May 2014
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FACTORY INSPECTIONS
Part IV: Guidance to Inspectors undertaking Factory Inspections on completing
form PD CIG 023: Factory Inspection Report
PRE-LICENCE INSPECTION
Completion of the report serves as a proof that the information given in PD CIG 022 Section
B.1 and B.2 is correct and that the quality system and the testing procedures as applied by
the Manufacturer will ensure the compliance with the requirements of the requesting
Certification Body(ies).
The visit has to be pre-announced to ensure that the contact person, knowledgeable of the
quality system is available.
The Manufacturer shall be made aware that at the time of the visit all relevant
documentation and test equipment shall be available and ready for inspection.
ROUTINE INSPECTION
Completion of the report serves as a proof that the quality system and test procedures, as
found during the Pre-Licence Inspection, are still maintained and are in compliance with the
current requirements of the requesting Certification Body(ies).
GUIDANCE TO INSPECTOR ON COMPLETING FORM PD CIG 023:
NOTE:
The Inspectors are requested to write the report in a legible manner.
“Inspection carried out by (Inspection Body) ...…”: Enter name of your inspection
organisation.
Reference number of the body carrying out the inspection: Enter the reference number used
by your organisation. This reference number shall be a unique reference number. In the
case the reference number is based on the file number of the Manufacturer e.g. a year/date
code of the inspection visit is to be added
The reference number has to be indicated at each single page.
Be sure to:
a) tick the boxes as appropriate;
b) explain clearly, and in each case, why you consider a question as ‘N/A’;
c) explain all ‘NO’ answers on the Inspector’s Findings page.
Records
The records need to be carefully reviewed
The minimum period the Manufacturer has to keep records shall not be less than the period
between two inspections. The Manufacturer shall state the retention period.
1
GENERAL INFORMATION
1.1
The address the Inspector should visit is given in PD CIG 022 Section B.2 under
B.2.1.
Enter the actual name and manufacturing address. Give enough information to
identify the Manufacturer.
1.2
Enter name and function of the Manufacturer's representative; also when the
Manufacturer’s representative was not present during the inspection.
The Manufacturer’s representative is the person to whom correspondence on
items related to factory inspections is to be send.
PD CIG 024 - May 2014
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1.3
Enter name(s) and function(s) of the main people involved in this inspection
1.4
Tick box  to indicate type of inspection(s). The inspection is considered basic if
“Others” is not crossed.
Cross “Others” only for a re-inspection or, for example, for a special sample
selection visit, etc. The type of special inspection is to be registered, including the
reference to the request of the Certification Body.
1.5
This question is only applicable for Pre-Licence Inspections and needs not to be
answered during Routine Inspections (Tick the N/A box).
In the case of a Pre-Licence Inspection check if the information given in PD CIG
022 Sections B.1 and B.2 is accurate and complete. If not, include the corrections
in PD CIG 022 Sections B.1 and/or B.2 and attach a copy of this document to the
inspection report.
1.6
Enter information as received from the requesting Certification Body(ies).
Example of how to fill out the table:
Certification
Inspection
Body requesting
X of Y
inspection
DEKRA
1 of 1
VDE
1 of 1
File Reference
No.
Category
Product
54818
30004711/5158297
HOUS
TOOL
Hair Dryer
Hand Held Drilling
Machine
NOTE:
Current list of abbreviations of Product Categories to be used to complete this table (and
other locations within the PD CIG 023 Factory Inspection Report) can be found under the
following path: www.eepca.eu  Document Server  OSM-FIP Public Documents 
Decisions.
1.7
Enter name of Inspector and date of inspection.
Remember to always complete the report in full, even if there is no production of
certified products. All details about the testing, test equipment and calibration are
equally important even if other products are in production.
2
VERIFICATION OF PURCHASED COMPONENTS AND MATERIALS WHICH
HAVE A SAFETY IMPLICATION ON THE CERTIFIED PRODUCT (INCOMING
INSPECTION)
2.1
The Inspector has to look for procedures used by the Manufacturer to ensure
compliance of materials, components and sub-assemblies. The personnel shall
have clear instructions on what and how to perform checks. There shall be
instructions as to which Certification Marks may have to appear on the
components/products in order to accept them as to comply with the standards. (PD
CCA 210 shows the various Certification Marks which may appear on a product or
component).
2.2
Tick the box(es) that are applicable; ALSO when question 2.2 is answered with
‘NO’.
When the Manufacturer performs an identification check, specify what is being
checked.
When you tick the box “Others”, specify what other method of verification is
performed.
2.3
Self-explanatory
PD CIG 024 - May 2014
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2.4
If a documented procedure exists please give reference.
If no documented procedure exists the procedure in place shall be observed and
described as found.
The Inspector’s description of the procedure shall cover at least the following
items:
– What action is taken by the Manufacturer, if the components/materials fail the
control requirements?
– Are the non-conforming components/materials clearly identified and/or
segregated?
– What are the instructions as to the disposition of non-conforming
components/materials?
– Does the system ensure that reworked components/materials are subjected to
the control requirements again, before being released?
– Are non-conforming components/materials recorded?
2.5
Regarding this question the Inspector has to evaluate the procedure and to verify
whether the procedure is sufficient.
The Inspector has to confirm that the applied procedure is satisfactory and will
continue to be so. If the procedure applied is not satisfactory, please report details.
2.6
Self-explanatory
2.7
Self-explanatory
3
PRODUCTION CONTROL, MONITORING AND ROUTINE TESTS
3.1
Look for instructions and check if they are understood and followed by all
personnel involved.
3.2
Is there sufficient information available to ensure that parts having an impact on
the safety of the finished products are properly manufactured/assembled
(mounted) and tested.
3.3
There shall be evidence that the production/assembly process is controlled in such
a way that the finished products are identical to the certified version.
3.4
Make sure that no product can pass the 100 % Routine Test without being tested.
3.5
Self-explanatory
3.6
The completion of the routine test table is to be based on the tests witnessed or
the test results recorded by the Manufacturer.
Enter on the TEST DATA SHEET the routine tests witnessed (indicate ‘W’).
For tests not witnessed, the routine test records shall be reviewed and data
entered in the table (indicate ‘R’).
Use the free space to describe other tests applied.
If more than one product category or insulation class is inspected use separate
test data sheets for each product category and/or insulation class.
For tests that could not be witnessed, the function of the test equipment is still to
be verified (indicate in 4.1).
PD CIG 024 - May 2014
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Example of how to fill out the table on TEST DATA SHEET – Routine Tests
TEST DATA SHEET – Routine Tests
No production
Production seen
Certification mark(s): VDE
Product: Microwave oven
Electrical Insulation Class: I
CB routine test requirements: EN 60335 / EN 50106 / VDE-PM 332
Category: HOUS
Type (model): M36
Rated voltage: 230 V
Test value
applied
Time
Factory limits applied:
a Earth continuity
100 %
12 V d.c.
10 A
2s
0,2 Ohm
Ohm (max.)
b Insulation resistance
100 %
500 V d.c.
4s
2 MOhm (min.)
Instrument
W
5 mA (max.)
Instrument
R
Instrument, Lamp Buzzer
Manual reset needed
W
Instrument
(e) cold
R
No Function
(f) yes
W
c
Leakage current
5%
230 V a.c.
Dielectric strength
Basic insulation
100 %
1 000 V a.c.
2s
30 mA (max.)
Supplementary
insulation
n/a
V
s
mA (max.)
Reinforced insulation
n/a
V
s
mA (max.)
e Load deviation
100 %
230 V a.c.
5s
+ 5  10 %
f
Functional test
100 %
230 V a.c.
Microwave leakage
100 %
230 V a.c.
50 W /m
Failure
indicated by
Remarks
Instrument Lamp
Including resistance of the
supply cord & plug
W
%
check
TESTS
2
W
W
e Indicate method used (hot/cold, at mains voltage, low voltage resistance check, etc.).
f Are all controls and components checked during the test?
W = Test witnessed by the Inspector; R = according to records
PD CIG 024 - May 2014
R
page 11 of 18
3.7
Check if the routine test procedure, performed by the Manufacturer, complies with
the routine test requirements received from the requesting Certification Body(ies).
Different certification bodies and/or different certification schemes may have
different requirements.
3.8
If a documented procedure exists please give reference.
If no documented procedure exists the procedure in place shall be observed and
described as found.
The Inspector’s description of the procedure shall cover at least the following
items:
– What action is taken by the Manufacturer, if the product fails a required test?
– Is the non-conforming product clearly identified and/or segregated?
– What are the instructions as to the disposition of non-conforming products?
– Does the system ensure that re-worked items are again subjected to
appropriate tests/inspections?
– Are non-conforming products recorded?
Tick the box(es) that is(are) applicable, also when question 3.8 is answered with
‘NO’.
3.9
Regarding this question the Inspector has to evaluate the procedure and to verify
whether the procedure is sufficient.
The Inspector has to confirm that the applied procedure is satisfactory and will
continue to be so. If the procedure applied is not satisfactory, please report details.
The Manufacturer shall provide visual identification of any non-conforming product.
If special segregation areas are used, make sure that they are clearly marked as
such.
3.10
In case of failures detected, verify that the Manufacturer has a procedure which
ensures that corrected items are again subjected to appropriate
tests/examinations.
3.11
Record shall be legible and identifiable to the products and shall specify tests
conducted.
3.12
Self-explanatory
4
FUNCTIONAL CHECK OF TEST AND MEASURING EQUIPMENT USED FOR
SAFETY TESTS
4.1
The Manufacturer must assure that the test equipment is functioning properly. The
test equipment must give a failure indication when the test result is outside
tolerances.
This verification is also to be performed in the case that there is no running
production of the certified product(s).
The Inspector shall look for evidence that this verification is done properly;
preferably by witnessing the verification.
4.2
Describe, by ticking a box, in which way the proper functioning of the test
equipment is checked.
Verify that the procedure how to perform the functional test is available and
understood by the operator(s).
If no written instruction is available, describe on Inspector’s Information page how
instructions are given and how understanding is verified.
PD CIG 024 - May 2014
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4.3
The Inspector shall verify that the Manufacturer has a system that ensures that no
products are shipped to a client before the correct functioning of the test
equipment has been checked.
As a minimum daily checks are recommended at the end of the daily production.
For lot production taking less than a day a check before and after the lot has been
produced is recommended.
4.4
Ensure that also all wiring is included in the verification of the proper functioning of
the test equipment.
4.5
The simulated failure (dummy, if used) shall represent the tripping limits used by
the Manufacturer during testing of the certified product. Directly short cut of the
test pins is not acceptable.
NOTE:
This does not apply to spark testers. This exception is based on the requirements given in the
standard(s) for certification of wiring, cables and cords.
4.6
Operators shall be instructed on what action to take if a test proves to be
unsatisfactory.
The Inspector shall check that the operator clearly understands these instructions.
4.7
The Inspector shall verify that the Manufacturer will identify all products checked
since the previous dummy test and will test these products again before
shipment to the client.
4.8
Check that corrective action is or will be recorded and include information of retested products.
4.9
Record shall include equipment identity number.
4.10
Self-explanatory
5
PRODUCTS SEEN IN PRODUCTION DURING VISIT
If there is production, tick the respective box and provide the requested
information.
If Certification Marks are not applied but nevertheless referenced in sales
information, installation instructions, manuals, etc. please state accordingly.
If there is no production of certified products, indicate if similar products were
manufactured and whether or not similar testing is applied.
For each product category and /or electrical insulation class that can be produced
by the Manufacturer a separate TEST DATA SHEET – Routine Tests table shall
be completed.
6
CALIBRATION OF SAFETY TEST AND MEASURING EQUIPMENT
6.1
The Inspector shall check that the Manufacturer maintains an effective
calibration/verification program.
The calibration/verification of the safety test and measuring equipment should
preferably be performed at least once a year depending on usage and the results of
previous calibration/verification. Less frequent calibration/verification need to be
explained by the Manufacturer to be appropriate e.g. by reasons of previous
calibration/verification results (no trend shift) or other engineering considerations.
Inspector needs to evaluate if this is reasonable.
6.2
This paragraph is covering the calibration of the reference equipment that is used for
the verification of the test and measuring equipment, as far as this reference
PD CIG 024 - May 2014
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equipment is available with the Manufacturer. (Information of the calibration/verification
of the test and measuring equipment on the production line is to be given in cl. 6.1)
6.3
Where the Manufacturer is using a method different from calibration labels, describe
the method used.
6.4
All calibration/verification undertaken shall be traceable to national/international
standards of measurement.
Records shall clearly identify the equipment and shall include as a minimum:
– date of calibration/verification
– test results (it is desirable that actual values be recorded – acceptance criteria
shall be defined.)
– next date of calibration/verification
– action taken, if found to be out of calibration/verification
NOTE:
Some NCBs require that records are signed.
6.5
Self-explanatory
6.6
Self-explanatory
7
HANDLING AND STORAGE
7.1
It is to be verified that the handling and storage of components and materials to be
used for production will ensure that no damage/reduction of properties will occur.
Attention is to be paid to e.g. identification, environmental conditions, Electrostatic
Discharge (ESD); First In First Out (FIFO) principle.
7.2
The handling and storage of finished products shall ensure that these products will
remain electrical and mechanical safe and will continue to comply with the
applicable certification standard(s).
8
PRODUCT VERIFICATION TESTS/PERIODIC TESTS (PVT)
NOTE:
Details of any non-required PVT should also be entered by the Inspector on t h e TEST DATA
SHEET – Product Verification Tests/Periodic Tests (PVT).
8.1
Describe on the TEST DATA SHEET (PVT) what tests the Manufacturer is
performing in order to verify continuous compliance of the certified products with
the relevant standard(s). Copy of the manufactures PVT record is also sufficient
PD CIG 024 - May 2014
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Example of how to fill out the table on TEST DATA SHEET – Product
Verification Tests/Periodic Tests (PVT)
TEST DATA SHEET – Product Verification Tests/Periodic Tests (PVT)
CB
LCIE
Product, Sampling rate, Standard’s clause or Test-parameters,
Results
PVT not required but performed by the manufacturer.
Hair dryer, type ER4, one unit per type per year from running production
Tests acc. to EN 60335-1: Marking, protection against electric shock,
mechanical strength, creepage distances, clearances.
Verification of components with originally approved versions
Dielectric strength test for class II – accessible metal parts against live parts
2 500 V a.c. 60 s
Abnormal operation: blocking air outlet – functioning of thermostat
Tests performed in Manufacturer’s own laboratory
No ongoing testing during visit, however records show that tests were
satisfactory.
8.2
Self-explanatory
8.3
Verify if specific equipment required by any Certification Body is available and tick
the relevant box. If the equipment could not be seen, for example because it was
located elsewhere than at the factory, then this shall be noted on the Inspector’s
Information page.
8.4
Self-explanatory
8.5
Verify that a procedure exist to take corrective actions if deviations are found.
Check if these corrective actions are sufficient.
In case no actions are taken or if you are in doubt about the actions taken, specify
on Inspector’s Findings page.
8.6
Self-explanatory
8.7
Self-explanatory
9
VOID
10
CORRECTIVE ACTIONS IN RESPONSE TO INSPECTOR’S EVALUATION
The Inspector shall verify that any unsatisfactory findings found during the last
inspection and entered in the last inspection report were corrected sufficiently. If
no or insufficient corrections were introduced then this shall be reported on the
Inspector’s Findings page.
The Inspector shall be convinced that any corrective action(s) taken by the
Manufacturer are acceptable to the Certification Body concerned.
11
QUALITY MANAGEMENT SYSTEM
Please mention the name of the organisation which assessed or certified the
Manufacturer.
State type and issued date of the certification.
NOTE:
Combined inspections/audits can be organized if the Quality System of the Manufacturer is audited
by the same organization as the Body carrying out the subjected factory inspection.
PD CIG 024 - May 2014
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12
MANUFACTURER’S SELF-ASSESSMENT OF THE MANUFACTURING AND
CONTROL PROCESS OF CERTIFIED PRODUCTS (FORMER: AUDITS OF THE
QUALITY SYSTEM)
12.1
The Inspector shall verify that the Manufacturer has a system which will ensure
that all tests/inspections/procedures are followed and are effective.
12.2
If records could not be examined, for example because they were located
elsewhere than at the factory, this shall be noted on the Inspector’s Information
page.
12.3
Self-explanatory
12.4
The Inspector shall verify the records of Manufacturer’s self-assessment on nonconformities and the way these non-conformities have been handled.
The Inspector shall also verify the actions taken on the non-conformities found.
13
VOID
14
TECHNICAL COMPLAINTS
14.1
Self-explanatory
14.2
Check if the management reviews technical complaints.
14.3
The records need to be carefully reviewed.
14.4
Self-explanatory
14.5
Self-explanatory
14.6
Self-explanatory
15
CERTIFIED PRODUCTS AND CHANGES TO CERTIFIED PRODUCTS
15.1
Specify in which way the Manufacturer has information regarding the construction
of the certified product(s) available.
15.2
Evidence that the reference is controlled by the Licence Holder shall be by
signature or other methods that link the reference to the Licence Holder.
15.3
The Inspector has to verify that the applied procedure is satisfactory and will
continue so.
15.4
Self-explanatory
15.5.1
Verify if any changes have been made to the certified version since the previous
inspection.
Tick the ‘YES’ or ‘NO’ box accordingly and note any statement of the
Manufacturer concerning this issue.
If the answer is ‘YES’, please answer 15.5.2.
If the answer is ‘NO’, tick ‘N/A’ for 15.5.2. This is not a non-conformity and need
not to be handled as such.
15.5.2
If the answer to 15.5.1 is ‘YES’ verify that these changes have been made with
the written authorisation of the Certification Body and the Licence Holder.
If the answer to 15.5.2 is ‘YES’ give details on the Inspectors Informative page
and/or provide objective evidence.
If the answer to 15.5.2 is ‘NO’ specify the changes made on the Inspector’s
Findings page. In this case the scoring of the Inspectors evaluation according to
17.2 cannot be better than 3 “Major unsatisfactory findings”!
PD CIG 024 - May 2014
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16
SELECTION AND SHIPPING OF RE-EXAMINATION SAMPLE(S)
Number of sample to be selected is normally specified on the PD CIG 022, Section
A or on the Certification Bodies factory inspection specifications.
Be sure to verify this information carefully, since selection and testing of reexamination samples can be an essential aspect of the product certification of the
requesting Certification Body.
Give information about where samples were selected and how they are transferred
to the Certification Body or Testing Laboratory by using code letter.
NOTE:
Some NCBs do not require their Certification Marks to appear on the product – Samples still need to
be selected if shown on their certification lists.
All comments related to the selected sample(s) shall be stated in the table
“Identification of selected samples” This may include information about changes
made to the product, suspected misuse of the Certification Mark, etc..
16.1
If no sample selection is made explain the reason why by using the tick box.
16.2
When a sample not bearing the Certification Mark is selected, explain why the
sample was selected by using the tick boxes. At least get Manufacturers
confirmation that the selected sample is identical to the certified product.
Care is to be taken when products are not marked but references are given in
sales pamphlets, installation instructions, manuals, etc. Follow the individual
Certification Bodies guideline if in such cases samples without any Certification
Mark applied need to be selected.
17
INSPECTOR’S EVALUATION
17.1
All unsatisfactory findings shall be recorded. The Manufacturer may propose
suggestions as to how he intends to correct the non-compliances identified. Please
note also such commitments. Where appropriate, the Licence Holder shall also
confirm the proposed corrective actions he intends to take to the requesting
Certification Body in writing.
Report the findings
Findings page’.
requiring
corrective
actions
on
the
‘Inspector’s
Report general matters such as change of address, name change, etc. on the
page entitled ‘Inspector’s Information page’.
NOTE:
Use separate Inspector’s Findings and/or Information Pages for different Certification Bodies and/or
Licence Holders if necessary; e.g. for reasons of confidentiality.
17.2
Inspector’s Recommendations:
Ticking of any box is based entirely on the Inspector’s judgement.
Any resulting consequences shall be notified by the requesting Certification Body
to the Licence Holder/Manufacturer and the Inspection Body in writing.
If a limited number of major unsatisfactory findings, where safety not directly
affected, is reported and where in the Inspector’s judgement an early routine
inspection is not necessary, then the Inspector may cross out “early routine
inspection recommended”.
17.3
Tick boxes for listed attachments that are included and number of the attachment
pages.
General remarks:
PD CIG 024 - May 2014
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The Manufacturer shall be made aware of the contents of the report.
The Inspector is required to give a copy to the Manufacturer's contact person who
shall sign for the receipt.
Time in factory: state amount of hours spent in factory.
Any matter which may be of an informative character shall be recorded on the
Inspector’s Information page.



This may include:
 technical matter discussed during the visit;
 matters to be checked in greater details during the next inspection visit;
 how and where the Certification Mark is applied;
 Manufacturer’s working hours, holidays or closing days.
PD CIG 024 - May 2014
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