A-1 (rev. 8) Measurement Canada Conducted Product Audits

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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.
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