When Does Change Control Get Invited to the Investigation Discussion?

Somewhere between “What is the solution? (#4)” and “The best way to implement the solution (#5)” but definitely before “Implement CAPA Solution” is another necessary quality system called Change Control. Where in your Deviation – CAPA process is the linkage or hand-off to Change Control? When does the Change Control request get initiated? Is it part of the Deviations SOP, built into the CAPA process or is it a separate stand-alone system? For novice investigators, this additional requirement is very easy to overlook by assuming that it falls within the boundaries of CAPA.

When CA’s require more than SOP revisions

Let’s examine typical corrective actions (CAs) more closely.  By far, rewriting SOPs to correct a procedural step or clarify the wording is the most common corrective action for a CAPA.  Initiating a document control request as per the SOP on SOPs is a pretty routine task and I generally don’t see deviations relating to “failure to open a doc control request for SOP revisions”.  But what about changes to batch records?  This gets a little bit trickier when rewriting a batch record step is a change to the process and most likely will require some kind of validation activity.  Some CAs involve changes to methods, materials or even vendors.  Again requiring change controls to be initiated.  Even changes to tech-enabled “GMP Systems” needs to be evaluated for a performance qualification under a change control protocol.

Change Control during a CAPA Investigation is not an afterthought

How is this managed where you work?  Is there any evidence in the Deviation –Investigation CAPA file that points to or includes the change control request, protocol, a/o final report?  How does the Lead Investigator ensure that this “big step” is being managed? Is it the responsibility of the CAPA team, the Lead Investigator or the Change Control Manager who happens to hear about it at a morning huddle discussion?

So instead of treating Change Control as an afterthought like an unwanted guest to a party, why not add one more tool to the problem-solving toolbox?  It’s called a Process Change Analysis.  The purpose of this tool is to explore identified process steps being considered for change.  (Available to Mailing List subscribers).

Add one more tool to the problem-solving toolbox

As part of steps 4 and 5 of the Problem Solving Model Approach, the investigation team examines the effect of the proposed change might have on the individual performer, other processes and systems.  Using the Process Change Analysis worksheet not only captures the implications of the proposed change but also provides the proper documentation for both the CAPA Investigation File and the Change Control Request.  Asking team members to consider what else might have to change allows for a more comprehensive change control project that gets coordinated alongside CAPA implementations.

Quality systems were never intended to stand alone and function as siloed departments.  A sign of a good functioning Quality Management System is how well the linkages (handoffs) are integrated and understood by employees and not duplicated by mistake or as a result of not knowing enough about other site quality systems procedures.

Summary of the HPISC Deviation – CAPA Blog Series

Alas, I have come to the end of the Deviation –CAPA blog series.  Thank you for allowing me to share my thoughts, air my frustrations and suggest ideas for expanding the problem-solving tool kit while staying within the boundaries of Quality Systems expectations.

1st in the series – The Big Why for Deviations – where I proposed that deviations and investigations provide rich learning opportunities to find out what’s going with our Quality Systems.

2nd in the series – Why Do CAPAs Fail Their ECs? – where I introduced the HPISC CAPA Performance Chain and suggested that the Effectiveness Check must map back to the CAPA that maps back to the root cause.

3rd in the series – The Investigation Hand Off: Is it a Handshake or a Missed Step? – where I urged QA personnel to clearly define the roles of the Initiator and the Investigator.

4th in the series – Investigations 101: Welcome Newbies – where I highly recommended a dedicated program to qualify Deviation Investigators.

5th in the series – Conducting Root Cause Meetings vs. Facilitating Problem Solving Discussions – where I suggested a broader problem- solving approach to get better at fixing our repeat problems.

6th in the series – Please Tell Me There Are More Tools Than 5 Whys and Fish Bone Diagrams – where I advised investigators to consider which tool to use to help make the right choice to maximize the tool results based on the investigation stage.

7th in the series – When Does Change Control Get Invited to the Discussion.

The next blog series is currently being mapped out.  Stay tuned for more updates by subscribing to the Theory vs. Blog.  Reach out to me if you wish to see a QA or Training subject be developed into a future blog series.

Until then visit the HPISC library for published articles, eBooks, white papers and impact stories.  I will not add your name to the mailing list without your permission. 

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Who is Vivian Bringslimark?