PERMANENT DOCUMENT
CIG 023
Factory Inspection Report
WARNING:
THIS DOCUMENT IS ONLY VALID IF USED BY ECS MEMBERS
AND THEIR AUTHORISED AGENTS
Approved by: Date of issue: Supersedes:
EEPCA, the European Electrical Products Certification Association
142, rue du Faubourg Saint-Denis – F-75010 Paris – Tel/fax: +33 140373563 – Email: secretariat@eepca.org
Document issued and distributed by EEPCA
© EEPCA 2009 – all rights reserved
ECS General Meeting, 22/23-04-2009 May 2009
PD CIG 023 - June 2004
Nr of pages: 19Page 1 of 19
PD CIG 023 reports shall not contain any unauthorised modifications which change the original meaning or the requirements. Any additions created to any document in the series shall be shown in an Appendix.
This document contains:
• two cover pages
• a report form of 12 pages
• Inspector’s Evaluation – Findings • Inspector’s Evaluation - Informative
• TEST DATA SHEET- Product Verification Test • TEST DATA SHEET Routine Tests
• IDENTIFICATION OF SELECTED SAMPLE
PD CIG 023 - May 2009.doc page 2 of 19
Reference number of the body carrying out the inspection:
FACTORY INSPECTION REPORT
Inspection carried out by (Name of Inspection Body): Reference number of the Body carrying out the inspection:
– For page control, please write this number in the header of each page (including the attachments) GENERAL GUIDANCE
– The questions of this factory inspection report are based on the requirements given in Permanent Document CIG 021.
– Guidance for the inspector is given in Permanent Document CIG 024.
– Both documents, PD CIG 021 and PD CIG 024 shall be taken into account during inspection. – Instructions to the Inspector are shown in italics
– The report shall be completed even if there is no production at the time of the visit.
– For all ‘NO’ answers details shall be provided on the INSPECTORS EVALUATION-Findings page
– For all ‘N/A’ answers rationale shall be provided as to why the item is not applicable – Details should be given on INSPECTOR’S EVALUATION-Informative page.
1.0 GENERAL INFORMATION 1.1 Manufacturer's registered name and factory location Manufacturer’s registered name:
Street address of the factory and Number: Postal code: City: County: Country: GPS-coordinates: (optional)
1.2 Manufacturer's representative name and contact data Manufacturer's representative name: Position: Position: Telephone: Fax: E-Mail:
PD CIG 023 - May 2009.doc page 3 of 19
Reference number of the body carrying out the inspection:
1.3 Record below the names and position held of the main people involved in the inspection same as mentioned under 1.2 If not the same as mentioned under 1.2 please give details Name: Position: Telephone: Fax: E-Mail: 1.4 1.5 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. 1.6 Inspection Details: Certification Body requesting inspection 1.7 Name of Inspector Date of inspection: (YYYY – MM – DD )Inspection File Reference X of Y No. Product Category Type of Product YES N/ANO Pre-Licence HAR Routine EMC ENEC Others: PD CIG 023 - May 2009.doc page 4 of 19
Reference number of the body carrying out the inspection:
2 Verification of purchased components and materials which have a safety implication on the certified product (Incoming Inspection) YES N/ANO YES N/ANO 2.1 Are materials, components and sub-assemblies verified by the manufacturer as complying with appropriate specification? 2.2 Does this verification also include the verification of the Certification Marks? Description of procedure (one or more boxes may be ticked) Rely on suppliers’ out-going inspection / Suppliers’ quality plan Audit conducted at the suppliers’ premises Supplier control based on manufacturers’ check list Conduct own incoming inspection Identification check Checked for correct type Comparison to a reference Rating Certification mark Certificate of conformity Others Details given on INSPECTOR’S EVALUATION-Informative page Description of the procedure or ref. of documented procedure & revision or issue date: Details are given on INSPECTOR’S EVALUATION-Informative page. 2.3 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 properly issued? 2.4 Is there a procedure covering the way to handle non-conforming components and materials? Description of the procedure or ref. of documented procedure & revision or issue date: Details are given on INSPECTOR’S EVALUATION-Informative page. 2.5 Is the procedure and the way in which it is applied satisfactory? (e.g.: components and materials clearly identified and/or segregated to prevent unauthorised use?) 2.6 Are records of the incoming inspection maintained and satisfactory? 2.7 Are records kept at least for the period between two inspection visits? YES N/ANO YES N/ANO YES N/ANO YES N/ANO YES N/ANO PD CIG 023 - May 2009.doc page 5 of 19
Reference number of the body carrying out the inspection:
3 Production Control, Inspection and Routine Tests YES N/ANO YES N/ANO 3.1 Are the Quality Assurance and manufacturing Personnel adequately briefed on their duties? 3.2 Do they have readily available up-to-date documents, manufacturing and test instructions, photographs, drawings or samples on all those parts which have an impact on the safety of the finished products? 3.3 Is there evidence that the production process ensures that the final product is identical to the reference version as described in clause 15.1? YES N/ANO 3.4 Is there a procedure to ensure that all products will be tested or inspected YES N/ANOaccording to the manufacturer’s requirements? Description of the procedure or ref. of documented procedure & revision or issue date: Details are given on INSPECTOR’S EVALUATION-Informative page. 3.5 Is the production process controlled at appropriate stages? 3.6 Are products inspected at appropriate stages of manufacture (Production Line Inspection)? Give details of all tests and inspections performed by the manufacturer and enter in the routine test table on the TEST DATA SHEET 3.7 Do the Routine Tests entered on the TEST DATA SHEET sufficiently cover all the Certification Bodies’ requirements? 3.8 Is there a procedure covering the way to handle non-conforming products? Description of the procedure or ref. of documented procedure & revision or issue date: Details are given on INSPECTOR’S EVALUATION-Informative page. Procedure of handling non-conforming products (one or more boxed may be ticked) Automated segregation process Manual segregation process Non-conforming products are destroyed Non-conforming products are repaired Others (please give details) Details given on INSPECTOR’S EVALUATION-Informative page 3.9 Is the procedure and the way in which it is applied satisfactory? (e.g. non-conforming products clearly identified or segregated to prevent unauthorised use?) YES N/ANO YES N/ANO YES N/ANO YES N/ANO YES N/ANO PD CIG 023 - May 2009.doc page 6 of 19
Reference number of the body carrying out the inspection:
3.10 Are repaired and reworked (corrected) items again subjected to appropriate tests/inspections in accordance with procedures? Description of the procedure or ref. of documented procedure & revision or issue date: Details are given on INSPECTOR’S EVALUATION-Informative page. 3.11 Are test records of the routine tests maintained and satisfactory? 3.12 Are records kept at least for the period between two inspection visits? YES N/ANO YES N/ANO YES N/ANO 4 Functional Check on Test and Measuring Equipment used for Safety Tests (Dummy Test) 4.1 Is there a procedure describing how the functional checks shall be conducted? Automated process Manual process Description of the procedure or ref. of documented procedure & revision or issue date: Details are given on INSPECTOR’S EVALUATION-Informative page. 4.2 Is there evidence that the functional check of the equipment is conducted YES N/ANOproperly, even if certified products were not in production? 4.3 Is a functional check conducted with intervals which will allow previous production to be retested if incorrect functioning is detected before it leaves the factory? 4.4 Is the proper function of the test equipment verified with a simulated failure YES N/ANO(dummy) or by other equivalent means? simulated failure (dummy) Test procedure according to the equipment manual Internal self test; test program included in equipment certification Internal self test; verified by the inspector 4.5 Is there evidence that the simulated failure (dummy) (if used) represents the tripping limits? 4.6 Is there a procedure requiring appropriate actions to be taken by the YES N/ANO operator if a functional check is found to be unsatisfactory? YES N/ANO YES N/ANO YES N/ANO PD CIG 023 - May 2009.doc page 7 of 19
Reference number of the body carrying out the inspection:
Description of the procedure or ref. of documented procedure & revision or issue date: Details are given on INSPECTOR’S EVALUATION-Informative page. 4.7 Is this procedure appropriate to ensure that improperly checked products are re-tested? 4.8 Are subsequent corrective actions taken recorded in all cases? 4.9 Are the test records of results of functioning checks of test and measuring YES N/ANOequipment maintained and satisfactory? 4.10 Are records kept at least for the period between two inspection visits? 5 Products seen in 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 kinds of products were manufactured at the time of visit. The manufacturing process should nevertheless be examined. At least one kind of product per product category and electrical insulation class shall be listed. No production Production seen Complete TEST DATA SHEET for each kind of product per product category and electrical insulation class even if there is no production. 6 Calibration of Safety Test and Measuring Equipment 6.1 Is test and measuring equipment used calibrated or verified? (several boxes may be ticked) Verification done by the manufacturer by means of calibrated reference equipment Calibration done by: Laboratory accredited according to ISO/IEC 17025 Test equipment manufacturer/supplier National metrology institute Other (please provide details): Provide details for at least one electrical measuring equipment: Kind of equipment: Type reference: Calibration reference number: Date of last calibration: Calibration due date: YES N/ANO YES N/ANO YES N/ANO YES N/ANO PD CIG 023 - May 2009.doc page 8 of 19
Reference number of the body carrying out the inspection:
6.2 Is reference equipment (used for verification) calibrated? (several boxes may be ticked) Calibration of reference equipment done by: Laboratory accredited according to ISO/IEC 17025 Test equipment manufacturer/supplier National metrology institute Other (please provide details): 6.3 Is the equipment provided with a label or similar indicating the next calibration/verification due date? 6.4 Do the calibration/verification records indicate that calibration is traceable YES N/ANOto national/international standards of measurement? 6.5 Are the records for calibration/verification of test and measuring equipment maintained and satisfactory? 6.6 Are records kept at least for the period between two inspection visits? 7 Handling and Storage 7.1 Are the components and materials to be used for production stored and handled in such a way as to ensure that they will continue to comply with the applicable standards? 7.2 Are the finished products stored and handled in such a way as to ensure that they will continue to comply with the applicable standards? 8 Product Verification Tests / Periodic Tests (PVT) 8.1 Are required PVT conducted? (one or more boxes may be ticked) NO PVT required, all questions of this section shall be marked with ‘N/A’ PVT conducted at the factory location PVT conducted at a external laboratory owned by the manufacturer PVT conducted at a external laboratory owned by the license holder PVT conducted by independent external laboratory PVT conducted by certification body’s laboratory Others (please provide details): Details are given on INSPECTOR’S EVALUATION-Informative page. If conducted at a location other than the manufacturers premises, then specify where performed: Details are given on INSPECTOR’S EVALUATION-Informative page. YES N/ANO YES N/ANO YES N/ANO YES N/ANO YES N/ANO YES N/ANO YES N/ANO PD CIG 023 - May 2009.doc page 9 of 19
Reference number of the body carrying out the inspection:
Note: Product Verification Tests shall be conducted under the responsibility of the manufacturer and may be named also as Periodic Tests or Sample Tests depending on the certification scheme. Describe which tests(required by the Certification Body/certification scheme) are conducted and at what sampling rate on TEST DATA SHEET – Product Verification Tests Note: Details of any additional product verification tests should be entered by the Inspector on the INSPECTOR’S EVALUATION instead of the TEST DATA SHEET 8.2 Are the tests conducted in accordance with procedures? YES N/ANO Description of the procedure or ref. of documented procedure & revision or issue date: Details are given on INSPECTOR’S EVALUATION-Informative page. 8.3 Is appropriate equipment that is required for conducting tests available? 8.4 Are the tests described in TEST DATA SHEET – Product Verification Tests in compliance with the requirements of the Certification Schemes and/or the requesting Certification Body? 8.5 Is there a procedure requiring actions to be taken if PVT are found to be unsatisfactory? YES N/ANO YES N/ANO YES N/ANO Description of the procedure or ref. of documented procedure & revision or issue date: Details are given on INSPECTOR’S EVALUATION-Informative page. 8.6 Are the records of product verification tests maintained and satisfactory? 8.7 Are records kept at least for the period between two inspection visits? 9 Void 10 YES N/ANO YES N/ANO Corrective actions in response to inspector’s evaluation YES N/ANO If there were any unsatisfactory findings entered in the previous inspection report, have these been corrected? Provide details of each unsatisfactory finding and how each has been resolved PD CIG 023 - May 2009.doc page 10 of 19
Reference number of the body carrying out the inspection:
11 Quality Management System If the manufacturer has a Quality Management System certified or assessed by an accredited Body, provide details of QMS standard, scope, name of certification body and certificate expiry date. or provide copy of the certificate. Quality Management System NOT certified Quality Management System certified by an accredited Body Quality Management System certified by a non accredited Body Copy of the certificate provided as appendix to this report Details of QMS standard: Does the scope covers the production of the certified product: YES NO Name of certification body: Certificate no.: Certificate issued date: Certificate expiry date: 12 Manufacturer’s self assessment of the manufacturing- and control process of certified products (Former: Audits of the Quality System) 12.1 Does the manufacturer regularly check that all procedures as required by YES N/ANOthe Certification Body(ies) and the harmonised inspection scheme (PD CIG 021) are followed? 12.2 Are records regarding results and actions taken available? Note: The use of PD CIG 023 to document the results of the self assessment is acceptable 12.3 Are the personnel carrying out above required checks appropriately trained and independent of the process being assessed? 13 Void
14 Customer Complaints The Manufacturer shall record any technical complaint regarding the certified product. The questions in this section shall be answered even if no customer complaints have been received. In this case the questions should be applied to the process 14.1 Is there a procedure regarding how to handle customer complaints? YES N/ANO YES N/ANO YES N/ANO PD CIG 023 - May 2009.doc page 11 of 19
Reference number of the body carrying out the inspection:
14.2 Are the received complaints reviewed on a regular basis regarding whether they are related to single errors or system errors? Actual case checked Procedure checked 14.3 Are corrective actions and decisions regarding customer complaints recorded? Actual case checked Procedure checked 14.4 Is the originator of the complaint informed about the handling and the result of the complaint? Actual case checked Procedure checked 14.5 Are the records of customer complaints maintained and satisfactory? 14.6 Are records kept at least for the period between two inspection visits? 15 YES N/ANO YES N/ANO YES N/ANO YES N/ANO YES N/ANO Changes to Certified Products YES N/ANO 15.1 Is reference about the certified version available? (one or more boxes may be ticked) Set of drawings Parts list Product description Reference sample Photo-documentation Other specification (Please provide details): Details are given on INSPECTOR’S EVALUATION-Informative page. 15.2 Is this reference under control of the licence holder? 15.3 Is there a procedure ensuring that no changes to the construction of certified products will be implemented prior to acceptance by the License Holder? YES N/ANO YES N/ANO Description of the procedure or ref. of documented procedure & revision or issue date: Details are given on INSPECTOR’S EVALUATION-Informative page. 15.4 If the manufacturer is also the licence holder: Is there a procedure ensuring that constructional changes of the certified product will be made only after approval by the Certification Body? YES N/ANO PD CIG 023 - May 2009.doc page 12 of 19
Reference number of the body carrying out the inspection:
Description of the procedure or ref. of documented procedure & revision or issue date: Details are given on INSPECTOR’S EVALUATION-Informative page. 15.5 Are any changes made to the certified version since the last inspection? no changes changes authorised by the license holder 16 Selection and Shipping of Re-Examination 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 Please give reasons why no samples were selected during the inspection: (one or more boxes may be ticked) None required by the certification body: No production, no stock: Build to clients’ order No access to warehouse Warehouse not at manufacturer’s location Manufacturer has been instructed to send re-examination samples: Others (Please provide details): Details are given on INSPECTOR’S EVALUATION-Informative page 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 (one or more boxes may be ticked) Type reference is mentioned on the certification bodies certification list Mark is applied on the package, catalogue or by other means Special sample selection order Others (Please provide details): Details are given on INSPECTOR’S EVALUATION-Informative page. YES N/ANO PD CIG 023 - May 2009.doc page 13 of 19
Reference number of the body carrying out the inspection:
17 Inspector’s Evaluation 17.1 List your findings on the INSPECTORS EVALUATION – Findings 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. 17.2 Give your recommendations by ticking the appropriate box 1 2 No unsatisfactory findings. Minor unsatisfactory finding(s). Grant or continue certification. Manufacturer’s 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). 3 Major unsatisfactory finding(s). Safety not directly affected. 4 Critical unsatisfactory finding(s), Safety directly affected. 17.3 Attachments: For page control, please write the reference number in the header of each attachment page.PD CIG 023 - Signature page No. of pages: ENEC Appendix to PD CIG 023 No. of pages: Copy of Quality Management Certificate No. of pages: Others No. of pages: Total no. of pages of this report including all 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. Printed copy provided Electronic copy provided Inspection duration: 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: Inspector’s name (printed letters): Date: Contact person’s name (printed letters) : Signature: Signature: For signature see attached signature page PD CIG 023 - May 2009.doc page 14 of 19
Reference number of the body carrying out the inspection:
Inspector’s Evaluation
=Related Findings
paragraph Inspector’s points requiring corrective action from the manufacturer
number of Use separate Supplementary Page for different Certification Bodies if necessary this report:
PD CIG 023 - May 2009.doc page 15 of 19
Reference number of the body carrying out the inspection:
Inspector’s Evaluation
Informative
Use separate Supplementary Page for different Certification Bodies if necessary
PD CIG 023 - May 2009.doc page 16 of 19
Reference number of the body carrying out the inspection:
TEST DATA SHEET - Product Verification Tests / Periodic Tests (PVT)
CB
Product, Sampling rate, Standards Clause or Test-parameters, Results
PD CIG 023 - May 2009.doc page 17 of 19
Reference number of the body carrying out the inspection:
TEST DATA SHEET - Routine Tests
No production Production seen Product Category (e.g. HOUS): Type number: Rated voltage: Certification mark: Kind of product (e.g. vacuum cleaner): Electrical Insulation Class: %
check
Test value applied V A V d.c. V V V V
Failure
indicated by
W R
TESTS
a Earth continuity b Insulation resistancec Leakage current
Dielectric strength Time s s s s s
Factory limits applied: Ohm (max.) MOhm (min.) mA (max.) mA (max.) mA (max.) mA (max.)
Remarks
Basic insulation 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
PD CIG 023 - May 2009.doc page 18 of 19
Reference number of the body carrying out the inspection:
IDENTIFICATION OF SELECTED SAMPLES Selected for Label No. Quantity at manufacturer:: Licence No. date Production period Code letters Product/Type/Technical data P S P S P S P S P S P S P S F T A F T A F T A F T A F T A F T A F T A
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 —
PD CIG 023 - May 2009.doc page 19 of 19
因篇幅问题不能全部显示，请点此查看更多更全内容