API Q1 & ISO 9001, CA Effectiveness

QUESTION:

From: Muhammad I.
Sent: Thursday, Feb. 28, 2013
To: ATCS Q-Blog
Subject: How to Determine Effectiveness of Corrective Action Taken

When dealing with a nonconforming situation, how can we ensure that API Q1 requirements for corrective actions have been adequately addressed?  Also, how can we determine that the corrective action taken was effective?  What evidence will be required to prove what we claim?
RESPONSE:

From: ATCS –Q-Blog, Ask the Experts
Sent: Thursday, Feb. 28, 2013
Dear Muhammad,

Thank you for contacting ATCS’s Ask the Experts.  With regard to your question, ISO 9001, clause 8.5.2 and API Q1 require that a documented corrective action procedure be established to address nonconformities to prevent their recurrence.  An effective corrective action procedure should require that a description of the nonconforming condition and reference to the specific requirement that has not been met be documented.  A CAR form is normally used for this purpose and to ensure all other 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 for root cause analysis, such as the “5 Whys”, “Fish bone diagram” or others, will vary based upon the level of severity of the nonconformance and its impact on the product, customers and stake holders.  In some cases, a root cause analysis may not be required.  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 or revisiting the situation after sometime as passed 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 was not identified.

Most corrective action procedures require that the action taken to prevent recurrence of a nonconformance be documented.  This is normally accomplished by use of a CAR form.  This form serves as objective evidence of the implementation of the Corrective Action procedure and provides a record of the corrective action taken (see 8.5.2, sub e).

I hope this helps.

Bill Aston, Managing Director, Aston Technical Consulting Services