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Head of SOLABS' Quality & Best Practices Unit - Tips for Communicating with FDA, EMA or Health Canada Auditors

5 Tips for Communicating with Auditors

Audits - 7 September 2016

By John Carkner, Senior Consultant, SOLABS Quality Assurance & Best Practices Unit

The best organizations look at audits as an opportunity to showcase their operations, and recognize that good audits are invaluable in emphasizing the importance of compliance to management and staff. A crucial aspect in relating to auditors is sticking to clear verbal communication norms. It is generally accepted that written communication must be intelligible and unequivocal, for example, in batch records and test notes. Likewise, we should be equally unambiguous in our verbal communication.

With that in mind, here are five tips for communicating with auditors:

1. Not every question can be answered immediately
This may sound pretty basic but it happens to be the best of us. We get so caught up trying to respond to questions quickly, that we offer answers even when we’re uncertain. Suggesting that you need to check the data or review the documentation shows a reliance on the systems that are in place, and should help to instil confidence in the mind of the auditor.

2. Avoid offering subjective opinions or speculation
There is a world of difference between saying a product was “not good” and saying that the product “exceeded an internal control limit”. Verbal communication should be based on fact as reflected in product documentation.

3. Don’t answer questions that weren’t asked
It is important to stick to the question at hand, and avoid divergence into related issues or other aspects of operations. Again, confidence in the capability of the organization is enhanced in the mind of the auditor when there is demonstrably strong focus on the issue under discussion.

4. Avoid adversarial responses
Sometimes people see audits as a challenge to their competence, and this can be reflected in the tone of their response. I’ve often thought the term “Ready Room” preferable to “War Room” in describing the area where supporting documents are marshalled for review. Auditors are not “the enemy”. Both sides of the table should approach the audit as an exercise to fairly evaluate the manufacturing and quality practices, and not as a win or lose situation.

5. Keep it simple
While the sum of all of the activities related to manufacturing and testing can become complex, in fact they represent a series of simple and repeatable steps. Our goal in training should be to convey the simplicity of operations, and this is achieved through a clear and well-designed training program. Employees at all levels of the organization should bear this in mind when interacting with auditors.

An audit generally evolves as an exercise in building confidence in the mind of the auditor that capable and effective quality and manufacturing teams are directing a company’s operations. This confidence-building is enhanced when the review of operations is clear and straightforward, both in verbal communications and document review. A robust Enterprise Quality Management System (EQMS) with a comprehensive audit trail can be an crucial tool for facilitating the delivery of self-assured responses to auditors’ questions.

About the Author
John Carkner has had a career spanning more than 35 years in the pharmaceutical industry. A microbiologist by training, he began his career in Quality Control with Pfizer Canada. John gradually took on more responsibility, including overall Quality for Pfizer’s Canadian manufacturing operations, eventually became Site Leader of their Arnprior, Ontario manufacturing site. When Pfizer divested the Arnprior site in 2009, John began a new phase of his career leading a contract manufacturing organization. He concluded his career as President and CEO of Pillar5 Pharma Inc., and after five years in contract manufacturing, moved to a less structured role as a consultant to the industry.

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