CIG

PERMANENT DOCUMENT

CIG 023

Factory Inspection Report

Approved by CIG on 20 April 2004

WARNING : THIS DOCUMENT IS ONLY VALID IF USED BY CIG MEMBERS AND THEIR AUTHORISED AGENTS.

Date of issue : June 2004 This documents supersedes CIG 023 issue January 2001

This document contains a cover page, a report form of 5 pages and: RECEIVING INSPECTION DATA SHEET TEST DATA SHEET Routine Tests and PVT IDENTIFICATION OF SELECTED SAMPLES Inspectors Evaluation - Informative Inspectors Evaluation - Findings

Secretariat held by EEPCA, the European Electrical Products Certification Association 142, rue du Faubourg Saint-Denis F 75010 Paris E-mail: [email protected] Document issued and distributed by EEPCA EEPCA 2004 Copyright all rights reserved

THIS DOCUMENT IS ONLY VALID IF USED BY CIG MEMBERS AND THEIR AUTHORISED AGENTS

FACTORY INSPECTION REPORT

RAPPORT DE VISITE DE CONTROLE EN USINE WERKS-INSPEKTIONSBERICHT

Inspection carried out by (Inspection Body)..................................................................

Note: - Instructions to the Inspector are shown in italics - For each question tick 'yes' or 'no' as appropriate. If a question is considered to be not applicable, use strike through (yes no) and write down the reason. - All 'no' answers require explanation on the INSPECTORS EVALUATION attachment page.

1
1.1

General Information
Manufacturer's registered name: ..................................................................................................................................................
and factory location: .......................................................................................................................................................................
.......................................................................................................................................................................................................................

1.2

Record below the names and position held of the main people involved in the inspection
....................................................................................................................................................................................................................... ....................................................................................................................................................................................................................... ....................................................................................................................................................................................................................... .......................................................................................................................................................................................................................

If any details such as address, contact person, tel., fax, etc. have changed since the last visit, record them. 1.3 1.4 Pre-Licence Routine ENEC Key Mark HAR EMC Special yes no

Pre-Licence only: Is the information given in the Questionnaire CIG 022 Section B accurate and complete? If 'no', amend the Questionnaire as appropriate and attach a copy to this report. Inspection Details: Inspection
1of 1, 1of 2, etc.

1.5

Certification Body requesting inspection

File Reference No.

Product Category

Type of Product

1.6 Name of Inspector: ...........................................................................................

Date of inspection: ..........................................................

CIG 023 Report June 2004

Page 1 of 5

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The following questions are based on Permanent Document CIG 021

The report must be completed even if there is no production at the time of the visit.

2
2.1

Goods Inwards Inspection

Are materials, components and sub-assemblies which have a safety implication on the finished product verified by the manufacturer as complying with appropriate specification including the CCA Certification Marks? Provide details in the table RECEIVING INSPECTION DATA SHEET. Note that only a sample of several components should be included, not a full list. yes no

2.2

If the manufacturer relies on Certificates of Conformity, do they clearly identify the product, quantity of items covered, the specification to which the products conform, the production date and are they signed or stamped by a person authorised by the supplier? Are non-conforming products clearly identified and/or segregated to prevent unauthorised use?

yes

no

2.3

yes

no

3
3.1

Production Line Inspection and Routine Tests

Are the Quality Assurance and Assembly Personnel adequately briefed on their duties? yes yes no no

3.1.1 Do they have readily available up-to-date documents, assembly and test instructions, photographs, drawings or samples on all those parts which have a impact on the safety of the finished products? Give details of all test and inspections performed by the manufacturer and enter in the table TEST DATA SHEET. 3.2 Do the Production Line Inspection and Routine Tests entered on TEST DATA SHEET sufficiently cover all the Certification Bodies requirements? Is there a documented procedure to ensure that all products will be tested or inspected according to the manufacturers requirements? Are non-conforming products clearly identified or segregated to prevent unauthorised use? Are trends of test results monitored and reported to the production and management authorities? Are repaired and reworked products re-inspected in accordance with documented procedures?

yes

no

3.3 3.4 3.5 3.6

yes yes yes yes

no no no no

4
4.1 4.2 4.3 4.4

Functional Check on Test and Measuring Equipment used for Safety Tests
Did the inspector witness the correct functioning of the equipment even if certified products were not in production? Is a functional check conducted with intervals which will allow previous production to be retested if incorrect functioning is detected? Is there a documented procedure for the functional checks? Is there a documented procedure describing actions to be taken if a functional check is found to be unsatisfactory? yes yes yes yes no no no no

Production during visit

Identify type number and any certification mark that appeared on products seen in production at the time of the visit. If no certified products were seen, indicate what kind of products were manufactured at the time of visit. The manufacturing process should nevertheless be examined.
...................................................................................................................................................................................................... ......................................................................................................................................................................................................

CIG 023 Report June 2004

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THIS DOCUMENT IS ONLY VALID IF USED BY CIG MEMBERS AND THEIR AUTHORISED AGENTS

6
6.1 6.2 6.3

Calibration of Safety Test and Measuring Equipment

Is test and measuring equipment calibrated? Is the equipment provided with a label or similar method indicating the next "calibration due" date? Do the calibration records indicate that calibration is traceable to an IAF accredited institute? Provide details for 6.1 6.3 for at least one measuring equipment on the INSPECTORS EVALUATION page. yes yes yes no no no

7
7.1

Handling and Storage

Are the finished products stored and handled in such a way as to ensure that they will continue to comply with the applicable standards? yes no

8
8.1

Product Verification Tests (PVT)

If no PVT required, then strike through the remaining questions in this section Are required PVT conducted? Describe which tests are conducted and at what sampling rate on TEST DATA SHEET If conducted at a location other than the manufacturers premises, then specify on the INSPECTORS EVALUATION page where performed. Is appropriate equipment required for conducting tests available? Are the tests described in TEST DATA SHEET in compliance with the requirements of the Certification Schemes and/or the requesting Certification Body? Are the tests conducted in accordance with documented procedures? Is there a documented procedure describing actions to be taken if PVT are found to be unsatisfactory? yes no

8.2 8.3

yes yes

no no

8.4 8.5

yes yes

no no

9
9.1 9.2

Records
Are records kept at least for the period between two inspection visits? Are the records listed below maintained and satisfactory? yes yes yes yes yes no no no no no yes no

9.2.1 Incoming inspection records. 9.2.2 Test records of the routine tests. 9.2.3 Test records of product verification tests (if required). 9.2.4 Records of results of functioning checks of test and measuring equipment. 9.2.5 Records of calibration of test and measuring equipment. If records were countersigned, provide details below. If not, explain below why not.

............................................................................................................................................................................................................................... ............................................................................................................................................................................................................................... ............................................................................................................................................................................................................................... ...............................................................................................................................................................................................................................

10

Corrective Actions
If there were any unsatisfactory findings entered in the previous inspection report, have these been corrected? Provide details regarding the corrective actions that have been taken . yes no

CIG 023 Report June 2004

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11

Quality System
If the manufacturer has a Quality System certified or assessed by an accredited Body, provide details of QMS standard, scope, name of certification body and certificate expiry date.

12

Audits of the Quality System

yes no

12.1 Does the manufacturer regularly check that all documented procedures as required by the Certification Body(ies) are followed? 12.2 Are records regarding results and actions taken available? 12.3 Is the personnel carrying out above required checks appropriately trained and independent of the process being audited?

yes yes

no no

13
13.1 13.2

Non-Conforming Products
Is there a documented procedure covering the way to handle non-conforming products? If no, then describe the process on the INSPECTORS EVALUATION page. Is the procedure and the way in which it is applied satisfactory? yes yes no no

14
14.1 14.2 14.3

Customer Complaint
If no customer complaints have been received then the following questions should be applied to the process Are records kept of customer complaints? Are corrective actions regarding customer complaints recorded? Does the manufacturer review customer complaints? yes yes yes no no no

15
15.1

Changes to Certified Products

Is there a parts list or similar evidence available specifying the components/parts to be used during production/ assembly of certified products? Is there evidence that this parts list is under the control of the Licence Holder? Is there a documented procedure ensuring that no changes to the construction of certified products will be implemented without the permission of the Licence Holder? If any change has been made to the certified product, has this change been made with the authorisation of the licence holder? If the Manufacturer is the Licence Holder: Is there a documented procedure ensuring that the Certification Body has accepted changes to the construction of certified products, before any implementation into a certified product? yes no

15.2 15.3

yes yes

no no

15.4

yes

no

15.5

yes

no

16

Selection and Shipping of Sample(s)

Regarding samples requested by the Certification Body(ies) please refer to the table IDENTIFICATION OF SELECTED SAMPLES and enter details as appropriate.

16.1

If you did not personally select the samples, explain why not and who did?
...............................................................................................................................................................................................................................

...............................................................................................................................................................................................................................

16.2

If the selected sample(s) do not bear the Certification Mark then provide the reason for selection in the table IDENTIFICATION OF SELECTED SAMPLES

CIG 023 Report June 2004

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17
17.1

Inspectors Evaluation
List your findings on the INSPECTORS EVALUATION page(s) by referencing the applicable clauses in this report (including comments, recommendations, etc.) and explain them to the manufacturer. If possible indicate also the corrective actions the manufacturer intends to take. Give your recommendations by ticking the appropriate box: 1. No unsatisfactory findings. 2. Minor unsatisfactory finding(s). Grant or continue certification. Manufacturers corrective action(s) will be checked at next visit. Grant or continue certification. Manufacturer shall confirm corrective action(s). Grant or continue certification. Special or early routine inspection recommended for checking corrective action(s). Certification refused/suspended and repeated factory inspection recommended after the manufacturer has confirmed implementation of corrective action(s).

17.2

3. Major unsatisfactory finding(s), safety not directly affected.

4. Critical unsatisfactory finding(s), safety directly affected.

17.3

Attachments: RECEIVING INSPECTION DATA SHEET TEST DATA SHEET- Routine Tests and PVT IDENTIFICATION OF SELECTED SAMPLES

Inspectors Evaluation - Informative Inspectors Evaluation - Findings

ENEC Appendix to CIG 023 (4 pages)

Total number of attachment pages :

A copy of this report shall be provided to the undersigned contact person who should be aware of the contents and sign for its receipt. Time in factory: ..................... hours. The responsibility for ensuring that a product is manufactured in accordance with the standard to which it was originally approved rests with the licence holder.

Date: Inspectors name (printed letters):

Date: Contact persons name (printed letters) :

Signature:

Signature:

CIG 023 Report June 2004

Page 5 of 5

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RECEIVING INSPECTION DATA SHEET

Safety critical item Goods receiving process (e.g manufacturers inspection; certificate of conformity; suppliers quality plan)

Attachment page no._1

Nature of Manufacturers inspection

PD CIG 023 June 2004

THIS DOCUMENT IS ONLY VALID IF USED BY CIG MEMBERS AND THEIR AUTHORISED AGENTS

TEST DATA SHEET

Routine Tests
PRODUCT CATEGORY: ............................................................................................... TESTS a. Earth continuity b. Insulation resistance V d.c. c. Leakage current V
Dielectric strength

Attachment page no._2

CLASS: ............................. Remarks W R

% check

Test value Time applied V A s s

Factory limits. Failure applied indicated by Ohm max. MOhm min. mA max. mA max. mA max. mA max.

Basic insulation V V V s s s

Supplementary insulation Reinforced insulation e. Load deviation f. Functional test

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

Product Verification Tests

CB Product, Sampling rate, Standards Clause or Test-parameters, Results

PD CIG 023 June 2004

THIS DOCUMENT IS ONLY VALID IF USED BY CIG MEMBERS AND THEIR AUTHORISED AGENTS

Inspectors Evaluation Informative

Use separate Supplementary Page for different Certification Bodies if necessary

Attachment page no._3

PD CIG 023 June 2004

THIS DOCUMENT IS ONLY VALID IF USED BY CIG MEMBERS AND THEIR AUTHORISED AGENTS

Inspectors Evaluation
=Related paragraph number of this report:

Attachment page no._4

Findings
Inspectors points requiring corrective action from the manufacturer Use separate Supplementary Page for different Certification Bodies if necessary

PD CIG 023 June 2004

THIS DOCUMENT IS ONLY VALID IF USED BY CIG MEMBERS AND THEIR AUTHORISED AGENTS

Attachment page no._5

IDENTIFICATION OF SELECTED SAMPLES

Selected for Label No. Quantity

at manufacturer:
Product/Type/Technical data

date:
Licence Ref. No. Production period Code letters

Code letters: P = Sample from Production or S = Stock; F = Forwarded by the Manufacturer; T = Transported to the Certification Body by the Inspector; A = Shipped by the Inspection Agency * If requested samples for particular CB were not selected, please explain why in the table.

PD CIG 023 June 2004