Blog Archive

Monday, April 6, 2015

Internal Audits - The ideal CA/PA tool?




The way it's always been done!
You’re familiar with using the 5-Why mantra, the fishbone, and the 8-step CA/PA problem-solving report. What about performing an internal audit as a root cause tool? During my years of observing RCCA investigations, a review of internal audit reports of the affected process was never done or considered as "important". The CB auditor reports for the certification and surveillance audits were also never reviewed. When suggested as part of the history review of the process or product problem, colleagues quickly denounced such a review as a complete waste of time.

Why is this?
While audit reports might be only summaries, they give valuable insight into the present problems...or trends of emergent issues...which could have been prevented. The usual reactions to a product problem and issuing a corrective action are either panic or annoyance. In both reactions the least amount effort, flavored with panic, is invested to quickly pull together the most likely root cause in accordance with management mandates, followed by applying a bandage that will get production back on line and customer shipments resumed.

What follow-on activities are ever considered for sustainability...or to see if anything might have become broken because of the patch and bandage? These are rarely pursued, in my experience. One of the mandatory documented procedures in ISO 9001:2008, Clause 8.5.2 - Corrective Actions – requires that the corrective action be reviewed for effectiveness,

f) reviewing the effectiveness of the corrective action taken”

How - or when! - do we review that a corrective action is effective? Do we run product until the problem re-appears…or disappears? Does the problem "fix itself"? Does the organization use an effective problem solving protocol and process to first understand what happened and then to begin to assess, contain, and resolve the problem?

Just the facts, ma’am
Conducting an audit of the particular product or process that “failed” is an excellent tool to determine the “current state” condition. The audit is performed with the engineering and hourly people involved, and helps to provide a uniform method for gathering facts, data, and opinions about the problem. Once these are collected, additional tools like the fishbone can help refine the current state conditions and assess if more information is required.

However, without taking the time to FULLY understand what happened and why - essential elements of the corrective action report – the RCCA effort will drift or bottleneck because of peer pressure, conflicting management mandates, and production shipment schedules.

In Closing…
Using the internal audit as an effective corrective action tool is invaluable. Sure, it will take longer – but as professionals, we know there is NEVER enough time to do things right the first time. Still how is it that we always seem to have plenty of time to do things twice…? 

Taking the time to ensure we use not just some tools but better tools is just as important as solving the problem.



No comments:

Post a Comment