Partners On Deviation (POD)

Partners on Deviation (POD)

A Mentoring program designed to improve the QA - Operations Parntership

In the best of all possible worlds - at least in biopharmaceutical manufacturing - QA works in a true partnerhsip with all other parts of the organization. There is a mutual understanding of each others roles, sufficient technical understanding on part of the QA and sufficient understanding of the role of QA and compliance concepts by operational groups to analyze and resolve any upcoming issue in a risk based approach.

Our experience however is that this is not a perfect world. In practically all organizations there is some friction; this is probably normal and unavoidable. But in some cases QORM Consultants have seen a complete breakdown of the QA - Operations partnership. Typical signs of such breakdown is a piling up of unresolved and unconducted investigations. Sometimes other areas, such as validations and change controls are effected, too. The situation is then compounded by undue pressure from senior management to "just get this material out of the door". It is not uncommon to see several deviations that have not been investigated for over 3 months. Needless to say that such a situation quickly draws regulatory scrutiny. But QORM Consultants also believe that these uninvestigated deviations constitute a missed opportunity to learn about pitfalls in the organization which, if properly remediated, could lead to significant cost and time savings.

Result of a breakdown of the Quality - Operations Parthership

As a sign of the breakdown of the QA - Operations partnerhsip, unresolved investigations pile up.

Anchor 1

As part of a regulatory committment, the client asked QORM Consultants to perform retrospective and prospective 3rd party review of investigations. There was a significant backlog of open deviations. Retrospective and prospective review of deviations showed that many lacked a "thorough investigation" as required by regulations, rather the participants seemed to just to through the motions. CAPAs appeared inadequate and not address true root cause. On QA analyst described the situation as "the purpose of the investigation is to close the deviation". Interestingly, it appeared that the severity of deviation was as often overestimated as it was underestimated. Obvious technical questions were not asked and most of all, it seemed that the intake report of deviations was particularly lacking, making later investigation of the issue more difficult.

Setup of the PODs

Together with the client the POD concept was developed. The underlying idea was that QORM Consultants would mentor QA agents who were dedicated to investigations through the deviation process. The purpose of the PODs was multifold:

Improve the intake reporting and early Quality Decision Making in the deviation process
Improve the professional relationships between QA and Operations
Accelerate the deviation process through early triage and close-out
Establish a path forward for more complex deviations

QA agents and QORM Consultants were stationed 24/7 on the floor. When a deviation occured, the POD would be dispatched to the scene of the incident and immediately start with interviews and information gathering. The PODs were empowered to call upon support from any group necessary, was it Facilities, Regulatory or QC. Senior management communicated clearly its expectation of immediate support.

To improve relationships the PODs were able to escalate contentious issues to an escalation forum to receive council. This way the personal relationships that were built did not get marred in accrimony and finger pointing.

In return for this extra effort QORM Consultants would "pre-approve" certain deviations, and complete approval would occur within 24 hours after the deviation occured. (NOTE: Care was taken that QORM Consultants would not approve their own work). This tactic helped to significantly reduce the backlog of open deviations and move away from the "constant firedrill" that had befallen the Quality organization.

The POD Deviation Process with the steps under the purview of the PODs highlighted in yellow (Click to enlarge)