Relevance of Process Based Auditing (PEAR) to regulated industry.

[v9991]

Since the emphasis is on compliance (well almost 100%); how relevant is PEAR concept for pharma/device industries?

How would you apply (any examples or do you have examples for same?

Here's what I am referring to:
http://elsmar.com/Forums/showthread.php?t=42296&highlight=PEAR+process+based+auditing

Refer to slide 8 of http://www.sae.org/iaqg/projects/9101changes.pdf

 

[Jen Kirley]

Good day v9991,

All audits arguably seek to verify compliance given that audits are, by definition, evaluations against a standard. The detail involves how we go about it. This site has had a number of lively discussions exploring the compare/contrast of compliance and process audits. They can be "mined" by clicking on the related thread links at the bottom of the page. Please note that when opening a new page, a new set of related links may be presented.

The process audit seeks to verify compliance on a wider scope than a focused compliance audit. A process audit can include input and output processes in its scope, which does not render it less of a compliance audit but may render it rather more shallow than a focused compliance audit. That is, the sample will be smaller and more widespread. This approach is not unsuited to regulated industries if the sample size can be made large enough to gain confidence of representation of population within an acceptable statistical error factor.

Does this make sense?

 

[v9991]

that really makes sense; + i got better clarity with your suggestions;

the point which is always bothering me was, that in regulated industry like us, all the observations are related utmost to the compliance ( even if it means effectiveness of a system stated as some provision of SOP not being met; thus, either observation or response is document-based which is most of times skewed to compliance and not improvement!!! what i mean is if there is observation of CAPA, then the response is documentation, training at most specific to that incident/activity; partly this may also be because of lack of formal management reviews....they do exist but they are limited to again compliance... not PA!!! ) and most probably thus robbing us of opportunity of independent reviews and driving improvements.
and, i am afraid that even fda's drive on improvement/CAPA would be still met with documentation/systems/compliance!!!

process based audits are 1 such concepts which will provide impetus to improvements; and someday we will also reach some quantifiable sigma levels in our processes as well. (btw, my perception is that sigma-levels/process-improvements are not so much heard in regulated industries and even if they exist are removed/disconnected from QMS!!!)

 

[Jen Kirley]

I would like to now reiterate that process auditing is a method; a means to go about verifying compliance. Arguably the effectiveness could be better evaluated since process audits take into account the outputs of activities; being really effective means being thorough enough to evaluate a sample of sufficient size to gain confidence the audit had enough depth to capture true, representative conditions.

When we point out nonconformances they will still be compliance based. However, we can take it a step further by making sure we include the three points:

1) What was seen
2) What the requirement said (the description of nonconformance)
3) Why it matters (efficiency)

#3 is arguably the most difficult because viewpoints of efficiency can vary. Economists define productivity as "The rate at which goods or services are produced especially output per unit of labor" while QA people tend to add the QA factor into the statement, to say "The rate at which goods or services are produced correctly the first time, especially output per unit of labor." Very often the auditor is not welcomed to evaluate efficiency; the organization assigns that authority and had better ensure the auditor is qualified and chartered to consistently deliver insights of efficiency. I can vouch that it is a well developed organization indeed which can accomplish this effort in a robust fashion.