Background: This question was received from a person that recently completed an Exemplar Global RTP, API Q1 Certification Workshop.
Question: If any concerns regarding improvement are identified while conducting an internal audit, should the Auditor issue a preventive action ?
ATCS Comment: It's important to remember a Preventive Action Request (PAR) is always proactive. It's an action taken to prevent the occurrence of a nonconforming ...
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Auditing
Keeping Current
The case for continued professional growth
Written by Bill Aston, Published in ASQ QP Magazine, June 2018.
It sometimes may seem that as soon as an organization becomes familiar with a management system and its requirements, changes must be made to meet newly identified customer requirements or to comply with recently issued editions, revisions, errata or addendums to the standard or specification.
Changes in every industry, standard, ...
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API 6A Monogram Restricts Remanufactured Equipment
Inquiry: My question is regarding application of the API monogram. Our company is an API 6A licensee. We manufacture valves and other related equipment at our facilities here in the USA and overseas. During a recent re-certification audit, the Auditor told us that we could not monogram valves if they had been disassembled and reassembled. These are new valves, so why is this even a concern, especially since the valves were ...
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Certified Enterprise Risk Manager
A firm working knowledge of risk management has become an essential part of being an effective Auditor. Unfortunately, those that don't ungraded their skills in this area will begin to find themselves at a disadvantage when compared to other fellow quality professionals. For this reason, every Auditor should consider improving their knowledge and skills on the subject of risk management.
During February 2015, I attended a 5-day CERM Workshop. ...
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ISO 9001:2008 vs. 2015, Receiving Insp.
Question:
Referring to ISO 9001:2008 clause 7.4.3, Verification of Purchased Product; since we are only a trading company that recieves a limited amount of purchased items at our site, please advise if this requirement is applicable to our organization. Thank You, Razif
Reply:
Hello Razif,
Thanks for contacting us. Regarding ISO 9001:2008, clause 7.4.3, verification of purchased product requirements; it’s important to remember the primary ...
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Tools for Auditing ISO 9001: 2015, Risk Based Thinking
Inquiry:
Question received via ASQ's Ask the Experts Blog, Published 10/21/2015
In addressing clause 4 of ISO 9001:2015 regarding organization context and interested parties, what type of tool (spreadsheet,diagram,flowchart,etc), would you recommend to use to simplify the practice and to give a proper understanding for auditors? I understand that risk evaluation (ISO 9001:2015) should be accomplished not only at a high level of establishing ...
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API Q2 Risk Assessment, Contingency Planning & MOC
Inquiry: Where can examples of how to implement API Q2 requirements for risk assessments, contingency planning and management of change be found? Suggestions are appreciated.
Maxwell
Reply: Hello Maxwell, ISO 31000 can provide some general guidance regarding risk management terminologies and methods. However, to fully understand what is actually required to meet API Q2 requirements for risk assessment, contingency planning and management of ...
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API Q1, Risk Management, Contingency Planning & MOC
In the event of changes that affect the QMS or organizational structure, does API Q1 require a corrective/preventive action to be initiated to document the MOC action?
Inquiry:
Hi Bill,
Firstly, going through the different queries on this site has been very helpful and greatly appreciated, that being said, I have still been in the grey about the whole MOC process. I know that a change in the QMS or organization structure will initiate an MOC ...
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ISO 9001 Audit Deferral – Force Majeure Event
Can An Audit Be Deferred Due To A Force Majeure Event?
The following inquiry was received from ASQ Ask the Experts on Apr. 10, 2015:
If a Force Majeure event (major storm, flood or other natural event) effects the company during the time that the annual Surveillance Audit was to be done, can the Surveillance Audit be postponed until after the conclusion of the Force Majeure period without losing ISO 9001 certification? Will the impact be 1.) ...
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