ICC-ES Requirements for Quality Documentation and Inspection of Manufacturing Facilities

Transcription

1 ICC-ES Requirements for Quality Documentation and Inspection of Manufacturing Facilities Quality Control Department ICC Evaluation Service, Inc. January 2011

2 Agenda AC10 AC304 Changes to AC304 Summary January

3 Rules of Procedure 3.0 Applications Data shall also include details of the applicant s quality control program in sufficient detail to verify that the manufacturer s quality system ensures the manufactured product will not change from the product described in the original qualifying data. 4.4 Data to be submitted in support of evaluation reports When periodic inspections are required, applicants shall obtain the services of a third-party inspection body that is acceptable to ICC-ES, and submit detailed quality documentation for the product or building system and the manufacturer s plant. 9.0 Qualifying Inspections For initial applications, and applications where new products or new manufacturing facilities are being added to an existing report, evaluation reports will be issued only after an ICC-ES representative, or a representative of an IAS accredited inspection agency, has performed a qualifying inspection at the facilities designated to manufacture products under the report. January

4 AC10 Acceptance Criteria for Quality Documentation AC10 Identifies specific requirements for information with regard to product specifications and the documented quality system. AC10 includes these three items: 1. Appendix A - technical information on the product 2. Appendix B - quality systems information 3. Required declarations January

5 Appendix A Appendix A is a guideline to providing supporting product information based on the requirements of AC10. All documentation submitted is to be dated. Appendix A can be used as a filled in form. January

6 Appendix A (continued) No. 1 Name of Product, material or system, including model number if applicable No. 2 Identify each component of constituent of the product that is supplied to the jobsite by the report applicant. January

7 Appendix A (continued) No. 3 Identify where the product and components are manufactured. No. 4 Briefly describe the manufacturing process. A flowchart would be helpful. January

8 Appendix A (continued) No. 5 Provide all relevant specifications for the product, the components and/or constituents used to manufacture the product, and components used with the product in the final assembly. No. 6 Describe the test procedures, and the conditions of acceptance, for incoming materials and for in -process and/or final product testing to ensure the product s performance is at least equal to that shown in the original qualifying tests. Describe any quality control tests required by the applicable acceptance criteria or standard. January

9 Appendix A (continued) No. 7 Provide the name of the inspection agency, if applicable, and provide evidence of a contractual agreement with the agency to conduct a minimum of four inspections per year (or for the number of inspections specified in the applicable acceptance criteria or agreed to by ICC-ES). No. 8 Describe how the product is labeled. January

10 Appendix A (continued) No. 9 Describe how the product or system is to be installed. No. 10 For products not required to have third-party inspections, provide a signed and dated declaration (from the report applicant) attesting that the product specifications submitted with Appendix A are consistent with those of the products tested to qualify for an evaluation report and with the products described in the test reports submitted to ICC-ES. January

11 Appendix A (continued) No. 11 For products required to have third-party inspections, enclose documentation from the accredited laboratory or inspection agency sampling the materials for testing, that the specifications of the materials sampled for testing are consistent with the specifications submitted with Appendix A. No. 12 Declarations required in Section 3.1 and 3.2 (if applicable) of AC10. January

12 Appendix B Appendix B is one of the quality document s used by the inspector while conducting the inspection. ICC-ES does not need to see the quality manual. The completed Q-21 Part B will be the actual record of official compliance. January

13 Appendix B (continued) January

14 Documentation for the Inspection Agency Once the review of the Appendix A supporting documentation is completed and the documents are found to be in substantial compliance, we will prepare a Q-20 Documentation Review Guide for the inspection agency to use during the qualifying inspection. The Q-20 along with the Appendix A documentation and Appendix B will be forwarded to the inspection agency for the qualifying inspection. January

15 Form Q-20 (Page 1) January

16 The purpose of the Qualifying Inspection The purpose of the Qualifying Inspection: 1. To verify that the manufacturer has the means, methods and manpower to produce the product being recognized in the report. 2. To verify that the manufacturer is producing a product that is consistent with the product being recognized in the evaluation report. 3. To verify the manufacturer has a documented quality system that meets the requirements of AC To verify that the manufacturer is operating in accordance with the documented quality system. January

17 Agency Conducts Qualifying Inspection Qualifying Inspection 1. Product must be in production during the qualifying inspection 2. Inspector will verify the Appendix A information on the Q-20 form. 3. The inspector uses information provided in Appendix B to verify the quality documentation is in use at the manufacturing facility and that the documentation meets the requirements of in AC The inspector will collect any information that is noted on the first page of the Q-20 page 5. The inspector will record information from the inspection on the most current version of the Form Q-21 inspection report. A copy of the Q-21 is to be left with the manufacturer and a copy sent to ICC- ES 6. The manufacturer needs to resolve all CARs. ICC-ES will follow-up with the inspection agency and the applicant until all CARS are resolved to the satisfaction of the inspector and ICC-ES. January

18 Qualifying and Follow-up Inspections If the product is not required to be under a follow-up inspection program, an ICC-ES representative will conduct the qualifying inspection. If the product is required to be under a follow-up inspections program, the agency contracted to do the follow-up inspection must conduct the initial qualifying inspection. October 16,

19 Form Q-21 (Page 3) January

20 Form Q-21 Report (Page 7) At a minimum we expect a brief summary of the inspection. This could be a positive statement such as: no CARs were issued, the quality system is in conformance to AC10 and the quality documentation. This could be a statement that references any deviations to the quality system for conformance to AC10 and reference the corrective actions issued. January

21 Inspection Done Prior Q-20 Review Or Fast Track Program In these circumstances, if the applicant believes that the quality documentation reasonably complies with AC10 and that the product specification or formulation being used in the manufacturing of the product is the same as what was tested and described to ICC-ES, the inspection agency can go forward with the qualifying inspection. The inspection agency will need to provide Appendix A (prepared by the applicant or the agency) and the supporting documentation used to verify the Appendix A information. ICC-ES will do a quality review with the documentation submitted with the Q-21 inspection report. Under these circumstances, ICC-ES reserves the right to request a re-inspection should there be significant nonconformances in the quality documentation or the inspection report. January

22 In Summary Application Applicant submits information required in Appendices A and B with supporting documentation. Review by ICC-ES QC Department ICC-ES QC Department reviews Appendix A information and documentation provided in support of Appendix A. Review by ICC-ES Engineer Engineer reviews Appendix A to verify that the test data matches what is in Appendix A. Information to Agency ICC-ES will provide to the agency the basic technical information about the product, including the Appendix A information and the Appendix B crossreference. This information is transmitted using Form Q-20. Information from Agency Agency records inspection findings on form Q-21. Agency submits Q-21 to ICC-ES for review and approval. January

23 AC10 Requirements for Follow-up Inspection Many ICC-ES acceptance criteria require third party inspections The submitted documentation shall specify the frequency of the inspections, which shall be unless agreed to otherwise by ICC-ES a minimum of four inspections reasonably spaced throughout the year, or as otherwise dictated by an applicable acceptance criteria or reference standard. The inspections shall: Assess the effective implementation of the manufacturer s quality system in accordance with the requirements of AC10. Verify that the product being manufactured is consistent with the product specifications provided to ICC-ES. January

24 Quality Control Inspection Summary Form **EFFECTIVE LATER IN 2011, THIS FORM WILL BE REVISED ALONG WITH AND THE RESPONSIBILITIES OF THE INSPECTION AGENCY ** January

25 AC304 Requirements for inspection agencies that conduct qualifying inspections of products, materials or systems recognized in ICC-ES evaluation reports. Requirements for agencies conducting follow-up inspections of products, materials or systems recognized in ICC-ES evaluation reports. Describes ICC-ES requirements that go beyond accreditation to ISO/IEC January

26 AC304 Inspection Agencies Inspection agencies shall comply with ISO/IEC Standard and shall be accredited by the International Accreditation Service (IAS) or by an accreditation body that is a partner with IAS in a mutual recognition arrangement pertaining to inspection bodies. AC304 Outlines four purposes for the qualifying inspection: The purpose of the qualifying inspection is to verify: (1) The manufacturer has means, methods and manpower to produce the product recognized in the evaluation report. (2) The manufacturer is producing a product that is consistent with the product being recognized in the evaluation report. (3) The manufacturer has a documented quality system that meets the requirements of AC10, specifically Appendix B of AC10. (4) The manufacturer is operating in accordance with the documented quality system. January

27 Notification AC304 Notifications 2.5 ICC-ES must be notified: 1. Prior to termination of the inspection agreement with the accredited inspection agency, when such termination is initiated by the report holder. 2. If there is a failure to conduct unannounced follow-up inspections in accordance with the approved quality documentation. 3. Whenever an inspection agency indicates a major quality control deficiency, as determined by the agency, it shall be brought to the attention of the manufacturer for correction. If the deficiency is not corrected it is to be brought to the attention of ICC- ES. January

28 Adding or Moving Manufacturing Location When there is no significant change (Section of AC10), the inspection agency shall supply a letter stating that there has been no change to manpower, personnel or the manufacturing process. When there is a significant change (Section of AC10) we need the following: Appendix A and B Qualifying Inspection Data demonstrating that products manufactured at the new location are equivalent to products previously recognized in the evaluation report. Above might be in the form of a letter from the inspection agency. January

29 Finding information and forms on our website January

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32 Right click here for Appendix A Right click here for Appendix B Right click here for Q-21 Inspection Form January

33 Thank you for your interest. Are there any questions? For more information: Web: Phone: January