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 ...
Read More
QMS Basics
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 ...
Read More
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.) ...
Read More
API Q1, 9th edition – Risks, Contingency Plans and MOC
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 ...
Read More
API Q1, 9th Edition – Critical Supplier
QUESTION:
From: Joe St. J.,
Sent: May 1, 2014
To: ATCS - QBlog, Ask The Experts
Subject: API Q1, 9th Edition, Critical Suppliers
Joe St. J, asks the following about APIQ1:
Hello,
Our company remains in the process of transitioning to API Q1, 9th edition.
While reading sections 5.6.1.2 and 5.6.1.3, one of our suppliers we purchased materials from for our final product that some of his products we deem as "critical" for our final product ...
Read More
API Q1, 9th Edition – Verification of Proprietary Product vs. Receiving Inspection
Muhammad I. asked the following question:
API Q1, 9th edition, clause 5.6.1.2, Section b) and Sub-section iii) requires the organization to verify that supplied product conform to stated requirements when limited by proprietary, legal and/or contractual arrangements.
How is this requirement different from - API Q1, 9th edition, clause 5.6.3, which states that “The organization shall ensure and provide evidence that purchased product and ...
Read More