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
Corrective action
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 Ed., Quality Policy vs. Objectives
QUESTION:
From: T.S. , Tercel Oilfield
Sent: Jan. 20, 2014
To: ATCS - QBlog, Ask The Experts
Subject: API Q1, 9th Ed., Quality policy and Objectives
Am I correct in saying that Objectives should establish the highest overall expectation and direction of the Top Management and that S.M.A.R.T. Goals should then established by the different departments and personnel that are in support of achievement of the Objective?
For instance, each ...
Read More
ISO 9001:2008 & API Q1 – Effectiveness of Corrective Actions
QUESTION:
From: Muhammad Irshad
Sent: March 1, 2013
To: ATCS - QBlog, Ask The Experts
What type of evidence must be provided to prove API Q1 requirements for corrective actions have been met? How can we determine that our corrective actions are effective?
RESPONSE:
From: Bill Aston, ATCS - QBlog, Ask The Experts
Sent: March 2, 2013
Hello Muhammad,
Thanks for contacting Aston Technical Consulting Services' QBlog. With regard to ...
Read More
API Q1, Clause 8.4, Measurement, Analysis & Improvement
QUESTION:
From: Valser Oil and Gas
Sent: Sept. 20, 2012
To: ATCS – Ask the Expert
Subject: ISO TS29001/API Q1, Clause 8.4, Measurement, Analysis and Improvement
Valser Oil and Gas asks the following about ISO TS29001/APIQ1 :
API Q1, clause 8.4, identifies four areas that must be monitored for improvement. These areas include customer satisfaction, product conformity, process trends and supplier performance. Should internal audit ...
Read More
ISO 9001:2008 Record Availability Requirements
QUESTION:
From: An Inquiry From ASQ 's Ask the Experts Program
Sent: June 7, 2012
To: ATCS - Ask the Expert
Subject: ISO 9001:2008 QMS Requirements – Record Availability
During a recent second party audit, the customer's Auditor asked to be provided with specific records for review. This request was made near the end of a one day audit with less than an hour remaining in the audit. The requested records were associated with parts ...
Read More
Does CMMI, Level 3 Conformance Ensure ISO 9001 Certification?
The following question has been asked:
“Does a software company need to conform with or be capable of meeting CMMI level 3 guidelines in order to become ISO 9001:2008 certified?” Our company is working toward obtaining ISO 9001:2008 and CMMI certifications. I have studied ISO 9001 and mapped sections to CMMI goals and practices.
It appears that some sections of ISO 9001:2008 map to CMMI Level 3 process areas and practices e.g., section 5.6.1 ...
Read More
What Does ISO 9001 Require, If An Obsolete Standard Has Been Used?
QUESTION:
If an organization uses an outdated standard and later replaces it with latest revision after product has been shipped, what could be the adverse impact of products delivered to customers, if any? What action should be taken?
Question submitted by F. Ahmed
REPLY:
Thanks for contacting us.
With regard to your question; ISO 9001:2008, clause 4.2.3, sub. g, requires outdated (obsolete) documents to be identified to prevent their ...
Read More