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A2LA Updates

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Specific program       requirements        completed by the inspection body           deficiencies. Understanding why an
(examples)                                 staff or contracted consultants of the     event occurred is the key to developing
                                           organization are acceptable.               effective corrective actions. In some
R310 – Specific Requirements: Special                                                 cases, the root cause is singular and
Inspection Agencies Inspection Body        Question: My internal audit process        easily discerned; in most cases it is not,
Accreditation Program (only for special    consists of only completing the A2LA       and there may be multiple root causes.
inspection agencies)                       C301 checklist - is this sufficient to     Because of this, there is no single
                                           demonstrate a complete internal audit      ‘recipe’ that can be followed. While it
R311 – Specific Requirements: Federal      per Section 8.6.1 of ISO/IEC 17020?        is impossible to create a procedure that
Risk and Authorization Management                                                     would apply to all scenarios, there are
Program (only for FedRAMP)                 RESPONSE: Not necessarily - The            some guiding principles which can be
                                           standard calls for the inspection body to  employed, the most important of which
R318 – Specific Requirements: Forensic     “verify that it fulfills the requirements  is that the root cause should address the
Examination Accreditation Program          of this International Standard, and that   question: “Why did this deficiency occur?”
(only for forensic inspection)             the management system is effectively
                                           implemented and maintained.” An            Other points to consider:
R332 – Specific Requirements: NFPA         inspection body must provide evidence
Field Evaluation Bodies (only for NFPA     that their internal audit consists of at       n Statements of root cause which
field evaluation bodies)                   least the following:                           are essentially a restatement of
                                                                                          the nonconformity provide no new
QUESTION: Per Section 8.4.2 of             n Determination of compliance with all         information beyond the facts of what
ISO/IEC 17020, what is the minimum         ISO/IEC 17020 requirements;                    was found and are not considered to
amount of time I must retain records?                                                     be an acceptable response.
                                           n Determination of compliance with
RESPONSE:  In some instances               all policies, procedures, inspection           n Each nonconformance should be
                                           processes, instructions, etc. that form        evaluated independently.
external requirements, standards           your management system;
                                                                                          n While each nonconformance and
and specifications provide specific        n Determination of compliance                  its associated root cause should be
                                           with all relevant A2LA policies and            approached individually, trends in
requirements for the retention of          requirements.                                  the identified root causes for a group
                                                                                          of non-conformances is a strong
records. If there are no specifics         This can be done on the C301 checklist         indicator that further investigation
                                           by confirming compliance and providing         is needed. For example, upon
provided then A2LA’s R102 - Conditions     detailed notes on the objective evidence       conclusion of an assessment during
                                           reviewed in making that determination.         which 8 non-conformances were
for Accreditation, item 4 states, “Retain  Where such detailed information on the         cited, it is determined that the root
                                           C301 is not provided, the inspection           cause of 6 of the 8 non-conformances
all quality records and technical          body must maintain additional                  pertain to employee training. In this
                                           evidence that all requirements noted           example, additional investigation
records supporting reported results        above were audited.                            into the employee training program
                                                                                          would be prudent and should be
throughout the period between A2LA         QUESTION: Per Section 8.7.4(b)                 evident in a response.
                                           of ISO/IEC 17020, what is meant
full assessments bearing in mind that      by “determining the causes of              Additional resources that may be of
                                           nonconformity” and how do I go about       help:
adequate records must be available         this?
                                                                                      “Presentation on Root Cause Analysis”
to demonstrate full compliance with        RESPONSE: Determining the cause            https://www.a2la.org/guidance/
                                           of nonconformity is deemed equivalent      Root_Cause_Presentation.pdf
the requirements for accreditation.”       to root cause analysis. Root cause
                                           analysis can be the most challenging       The February 2007 Issue of the A2LA
Therefore, at minimum records shall be     part of the corrective action process and  Newsletter
                                           should be used as a tool for continuous    https://www.a2la.org/newsletters/
retained for the period of time from one   improvement, which may reduce or           a2lanews_feb2007.pdf
                                           eliminate the likelihood of future
full assessment to the next.

QUESTION: Can the results of an
external audit be accepted as part of or
entirely in place of an inspection body’s
internal audit?

RESPONSE: No. ISO/IEC 17020 section
8.6.3 requires that the inspection body
conduct internal audits. With the
understanding that it is the inspection
body’s responsibility to conduct their
own internal audit, third party audits of
the organization are not acceptable for
meeting any portion of this requirement
of the standard. Only internal audits

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