API Q1, 9th Edition, Management of Change

ATCS – QBLOG, ASK THE EXPERT – September 14, 2013

QUESTION:

From: Muhammad Irhad
Company: EPC Services, Edmonton Alberta
Sent: August 23, 2013
To: ATCS – QBlog, Ask The Experts
Subject: API Q1, 9th Edition – Management of Change (MOC)

I have the following questions regarding API Q1, 9th Edition and its requirement for MOC.

1.  What would be a typical MOC process?
2. Do we need a documented procedure for MOC process?
3. MOC Implementation is required per section 5.11.2 or it will account for 5.3 a, b, c & d.

Your reply will be greatly appreciated.
RESPONSE:
From:Bill Aston, ATCS – QBlog, Ask The Experts
Sent:
August 26, 2013
To: Muhammad Irhad
Subject: API Q1, 9th Edition – Management of Change (MOC)

Hello Muhammad,

Thanks for contacting Aston Technical Consulting Services’ QBlog.  With regard to your question, please note the following.

1. MOC is applicable to any of the QMS processes that may impact the effectiveness of the quality management system, product delivery or product quality.
2. API Q1 does not require an MOC procedure, but an MOC process.  Which means that defined process steps need to be in place to ensure that changes are:
   1. Assessed for their potential impact on product delivery or product quality.
   2.  That internal and external communication systems are established to communicate require changes.
   3. That changes are documented and
   4. Responsibilities for completing the changes are assigned.
3. Section 5.11.2, defines the minimum that must be considered as a part of MOC.  However, as stated in 5.11.1, Risk assessment (5.3) must also be a part of the MOC process.

I hope this helps.
Best regards,
Bill Aston, Managing Director, ATCS
Kingwood, Texas