A-1 rev. 8 — Measurement Canada Conducted Product Audits Date: 2014-12-08 Bulletin: A-1, Rev. 8 Category: Programs for authorized service providers Document(s): Criteria for the Accreditation of Organizations to Perform Inspections Pursuant to the Electricity and Gas Inspection Act and the Weights and Measures Act (S-A-01). Supersedes: A-1, rev. 7 1.0 Purpose The purpose of this bulletin is to define the minimum product audit requirements and processes in order to ensure national uniformity and effectiveness for accreditation product audit activities performed by Measurement Canada. Note: For the purpose of this bulletin, the term “inspection” is used in a generic manner and is intended to include verifications and reverifications under the Electricity and Gas Inspection Act and examinations under the Weights and Measures Act. 2.0 Scope This bulletin provides a framework for planning, conducting and documenting product audits pursuant to the accreditation standard S-A-01, Criteria for Accreditation of Organizations to Perform Inspections Pursuant to the Electricity and Gas Inspection Act and the Weights and Measures Act. This bulletin applies to all regularly scheduled Measurement Canada product audits. 3.0 Objective of product audits The objectives of product audits are as follows: - to verify that accredited organizations’ inspection results are in accordance with legal requirements; and to assist Measurement Canada in monitoring the effectiveness of the accreditation program. The results of product audits may also assist Measurement Canada in monitoring the level of equity and accuracy in the marketplace. 4.0 Planning the product audit 4.1. General Product audits are to be planned by the Regional Auditor or Audit Team Leader responsible for assigned accredited organizations with headquarters located in his or her region. If an accredited organization has additional sites in other regions, planning must be done in conjunction with the regional coordinators, Alternative Service Delivery (ASD) and district managers or regional managers where the organization’s additional sites are located. Product audits must only be performed by trained and qualified Measurement Canada staff. Audit team leaders will be responsible for controlling the conduct of product audits; however, they may seek the assistance of other qualified Measurement Canada employees. 4.2. Planning weights and measures product audits Weights and measures product audits are to be planned in such a manner that as a minimum, over a three-year period, a device subtype for which a recognized technician is recognized and which he or she has inspected has been subjected to a product audit, with a focus on the complexity of the device subtype and, for volumetric devices, the complexity of the product. In addition, over a three-year period, all device subtypes under an accredited organization’s scope must be subjected to a product audit, provided that the organization has performed inspections of the device subtypes within that period. Every attempt must be made to cover all device subtypes within a three-year period. If this is not possible, the complexity of the devices should be considered when selecting the device subtypes to be audited. Product audits should also be representative of inspection methodologies and products, as well as device subtypes. Product audits normally occur without the presence of the recognized technician who previously inspected the selected device. However, in some cases (e.g. complex inspections, one of a kind inspections, devices for which Measurement Canada does not have the inspection equipment, remote areas, difficult to access locations) product audits can be performed by observing the recognized technician conduct the inspection. Within three months of a new recognized technician performing his or her first inspection, a device inspected by the technician must be subjected to a product audit. All authorized service provider and recognized technician monitoring must occur within three months of the recognized technician carrying out the inspection and must not be delayed any longer than 6 months from the performance of the examination unless otherwise specified. 4.3. Planning electricity and gas product audits Electricity and gas product audits are to be planned in such a manner that as a minimum, over a three-year period, some products inspected by each technician conducting final inspections have been subjected to a product audit and all meter categories under an accredited organization’s scope have been subjected to a product audit. For a fully automated system in an electrical manufacturing facility where there is a final inspection validation process or the system is self-validating and no inspector is involved in making decisions on the test and its results, there may be reduced benefits in conducting product audits at the manufacturing site using the automated system. In such cases, product audits may be conducted at Canadian utilities before the meters are distributed in the Canadian marketplace. 5.0 Conducting the product audit For electricity and gas product audits, an audit plan shall be developed and issued to the organization after the Audit Team Leader has consulted with audit team members. The plan should be designed to be flexible in order to accommodate changes based on the observations gathered during the audit. The audit plan should include as a minimum: - the audit objective and scope; the audit criteria; names of the audit team members; and the date, location and duration of the audit. It is not necessary to identify in advance the exact devices that will be evaluated during the product audit. An audit plan is not typically issued for weights and measures field product audits, but sufficient details must be included in the audit notification letter issued to the organization. Whenever possible, the Audit Team Leader should conduct an opening and closing meeting with electricity and gas organizations to ensure that they understand the scope and purpose of the audit as well as the results of the product audit activities. As a minimum, a closing meeting shall be conducted where nonconformances have been raised as a result of a product audit. Opening and closing meetings may also be conducted over the telephone. Opening and closing meetings are not typically conducted for weights and measures field product audits due to the nature of these audits. 5.1. Product selection Any device that is being, or has been inspected by an accredited organization can be selected for a product audit. A variety of devices should be selected. Devices selected for weights and measures product audits should be devices that have been certified by an accredited organization within the previous six months. When selecting electricity and gas acceptance or compliance sample meters, the same sample that has been inspected and tested by the accredited organization should be selected where possible. For product audits carried out to verify the results of inspections conducted at electrical manufacturing facilities with fully automated systems, as described in section 4.3 of this bulletin, the Audit Team Leader will select the product in consultation with the Regional Coordinator, ASD. 5.2. Test equipment selection Measurement Canada personnel should use the same measuring apparatus, test equipment and procedures that the accredited organization used to conduct the inspection. Measurement Canada-owned and certified test equipment may be used when the Audit Team Leader deems it appropriate. Measurement Canada-owned and certified test equipment should also be used to conduct field product audits. For product audits carried out to verify the results of inspections conducted at electrical manufacturing facilities with fully automated systems, as described in section 4.3 of this bulletin, the Audit Team Leader will select the test equipment in consultation with the Regional Coordinator, ASD. 5.3. Inspection process Measurement Canada inspectors conducting device inspections as part of product audits shall use either Measurement Canada’s or the accredited organization’s inspection procedures, as accepted by Measurement Canada, and take appropriate enforcement actions in the case of devices not meeting requirements. Inspection results are to be communicated to the Audit Team Leader responsible for the product audit for further review and investigation. 5.4. Nonconformances 5.4.1. Issuing nonconformances A nonconformance shall be issued by the Audit Team Leader responsible for the product audit when review and investigation of inspection results indicate that: - - accepted inspection procedures were not followed (i.e. devices inspected are not approved and/or within the organization’s scope, seals and markings were not used correctly, etc.); standards, measuring apparatus and test equipment are not properly maintained and used; documents required by Measurement Canada (i.e. reports, inspection certificates, records, questionnaires, etc.) are not accessible, complete, clear, accurate and submitted within required time frames. Note: - - - Measurement errors are not cause for a nonconformance on their own, but on investigation, may provide objective evidence of nonconformance related to the first two points above. If measurement errors or other problems are encountered during a product audit in the absence of the technician and these problems cannot be clearly attributed to work performed by the technician, then another product audit must be conducted within 30 days, or as soon as possible, after a device has been certified by the technician to further establish the cause of the problems. If the second product audit is still inconclusive, additional timely product audits must be performed. If, while observing a technician’s inspection, a Measurement Canada Inspector determines that the technician has misapplied accepted test procedures or improperly used standards, measuring apparatus or test equipment, resulting in a decision to pass a device that should have failed or failing a device that should have passed, a nonconformance should be issued by the Measurement Canada Regional Auditor. The Measurement Canada Inspector should discuss the observation with the technician following the inspection but prior to providing inspection data for the issuance of the inspection certificate by the technician. The inspection certificate should indicate a result acceptable to Measurement Canada. When a nonconformance is identified for more than one of the categories listed above, as a minimum, a separate Nonconformance / Corrective Action Report shall be issued for each category of nonconformance. 5.4.2. Corrective action Timelines for the organization to determine the cause and implement corrective action should be discussed. The default time allowance for addressing nonconformances is 15 working days from the date of issuance of the audit report, unless the organization justifies the requirement for more time. Timelines for closing nonconformances must be documented in the audit report. The Audit Team Leader shall take appropriate actions to prevent noncomplying devices from being introduced into the marketplace and to remove any noncomplying devices. 5.5. Issuing inspection certificates 5.5.1. Electricity and gas Inspection certificates shall not be issued for devices inspected as part of product audits conducted under the Electricity and Gas Inspection Act. 5.5.2. Weights and measures Inspection certificates shall be issued as required by section 19 of the Weights and Measures Act when devices are inspected as part of product audits conducted at factory and field locations. 6.0 Product audit reporting The product audit report shall contain as a minimum: - the accredited organization’s inspection results (inspection certificate numbers will be included, but the certificates will not be attached); the number of devices tested by Measurement Canada as part of a product audit; the number of devices exceeding specified tolerance; nonconformances generated as a result of the product audit. In all circumstances, a complete and detailed product audit report must be completed. 7.0 Audit completion The audit is completed upon submission of the audit report to the auditee. Any required follow-up action should be conducted in the same manner as quality system audit follow-up. 8.0 Corrective action follow-up The Audit Team Leader, in conjunction with the Regional Coordinator, ASD, shall review the root cause analysis and evaluate the proposed corrective action, and inform the auditee of their findings. Corrective action and subsequent follow-up audits should be completed within a time period agreed to and documented by the Audit Team Leader and the auditee. 9.0 Revisions The initial version of this bulletin became effective January 28, 2004. The purpose of revision 1 (February 23, 2005) was to: - reword section 3.0 for clarification; reword sections 4.2 and 4.3 for clarification; reword and reformat section 5.0 to more accurately describe the product audit, product inspection and nonconformance issuing process; and reword section 6.0 for clarification. The purpose of revision 2 (June 26, 2006) was to: - change S-A-01:2002 references to S-A-01; change the word client to organization throughout the bulletin; remove the word interim from section 1.0; reword sections 4.0 and 5.0 for clarification; introduce a timeline in section 4.2 for the initial monitoring, by product audit, of new weights and measures recognized technicians; and change the term Lead Auditor to Audit Team Leader in sections 5.3 and 5.4.1 of the English version. The purpose of revision 3 (February 15, 2007) was to indicate in section 4.2 that product audits should be representative of products, inspection methodologies and device subtypes. The purpose of revision 4 (July 4, 2008) was to: - harmonize sections 5.0, 5.2 and 7.0 of the French version to the English version; and to remove the first two sentences of section 8, as section 8.5.2 of accreditation standard S-A-01 already cover this subject. The purpose of revision 5 (December 11, 2009) was to: - modify sections 4.2 and 5.1 to indicate that in some cases, product audits can be conducted by observing a recognized technician conduct an inspection; and in the note section, add instructions to the Inspector and the Measurement Canada regional auditor on what to do should a mistake be observed while conducting a product audit in the presence of the technician. The purpose of revision 6 (January 30, 2013) was to: - modify section 4.2 to clarify that device subtypes are subject to product audits and that product audits can be performed by observing the recognized technician conduct the inspection; modify section 4.3 to include a fully automated system in an electrical manufacturing facility; modify section 5 to address fully automated systems in electrical manufacturing facilities and weights and measures field product audits, and to clarify the note in 5.4.1; and make minor editorial corrections. The purpose of revision 7 (October 31, 2013) was to: - correct minor errors in the French version; and modify the Note section in 5.4.1 to clarify what Measurement Canada will do when measurement errors or other problems are encountered that are not clearly attributed to a technician's work. The purpose of revision 8 (December 8, 2014) is to: - explain use of the term inspection in this document; modify in section 4.2 the requirements related to planning weights and measures product audits; modify in section 5.4.1 the conditions for issuing non-conformances; make minor editorial corrections. 10.0 Additional information For additional information regarding this bulletin, please consult the contact us section of the Measurement Canada website or your departmental contact. The copy of this document located on Measurement Canada’s website is considered to be the controlled copy.