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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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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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QUESTION:
From: Fayyaz Ahmed
Sent: Feb. 10, 2015
To: Q-Blog, Ask the Experts
Subject: API Q1, clause 5.3, Risk Assessment and Management
Fayyez Ahmed asks the following about API Q1:
An organization started its transition from API Q1 8th to API Q1 9th edition during September 2013. They still had not performed risk assessment between June -Nov 2013. This organization was audited by the API during Jan 2014. However, API Auditor did not ...
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QUESTION:
From: Jamil K.
Sent: Dec. 11, 2014
To: Q-Blog, Ask the Experts
Subject: API Q1, clause 4.4.1, sub. e., Documentation Requirements - General
Jamil K. asks the following about APIQ1:
API Q1, 9th Edition, requires an organization to identify legal and other applicable requirements to which it claims compliance. Please provide any insight as to what kind of items should be considered. We manufacture manifolds, valves, chokes and ...
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QUESTION:
From: Yusri
Sent: Aug. 12, 2014
To: Q-Blog, Ask the Experts
Subject: API Q1, clause 5.3, Risk Assessment Requirements
Yusri asks the following questions about API Q1:
API Q1, requires the organization to maintain a documented procedure for risk assessment and management. What parameters need to be considered for determining risk and their impact on delivery and quality of product? Should the risk assessment be performed before ...
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QUESTION:
From: Darcy K.
Sent: May 10, 2014
To: ATCS - QBlog, Ask The Experts
Subject: API Q1, 9th edition, Risks, Contingency Plans and MOC
In regard to MOC Process, in your opinion, would it be effective to tie this into corrective and preventative actions? Any corrective or preventative actions that require changes to the QMS also require MOC, and risk assessment as well and furthermore, tying in any contingency plans that require QMS ...
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