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 your question, ISO 9001, clause 8.5.2 requires that a documented corrective action procedure be established to prevent the recurrence of nonconformities.  API Q1, supplemental requirement 8.5.2.1, requires that corrective actions taken are effective.  Therefore, it’s important that the corrective action procedure require that a description of the nonconforming condition and reference to the specific requirement that has not been met be documented.  The procedure must ensure that all requirements of clause 8.5.2, subs a through f are addressed.  As you are aware, prior to taking any corrective action, the root cause of the nonconforming condition must be identified to prevent a recurrence (see clause 8.5.2, subs b and c).  The methodology used to identify the root cause analysis may vary based upon the level of severity of the nonconformance and its impact on the organization, product, customer and stake holders.  In some cases, root cause analysis may not be required at all, but again, the level of severity, frequency and complexity of the nonconforming condition must be considered.

The effectiveness of the corrective action (CA) taken can be evaluated by monitoring the situation to determine if there has been any recurrence of the nonconforming condition (see 8.5.2, sub f).  This should be done prior to closing the CAR.  If there is a recurrence of the nonconforming condition, then the root cause has not been identified.

A part of the correct action process requires that the corrective action taken to prevent recurrence of a nonconformance is documented.  This is normally a part of the CAR record and it serves as objective evidence of the effectiveness of the corrective action process (see 8.5.2, sub e and API supplemental requirement 8.5.2.1).

I hope this helps.

Best regards,

Bill

Best regards,

Bill Aston, Managing Director, ATCS

Kingwood, Texas