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Foolproof Batch Records Quality Culture Approach

Foolproof Batch Records – Quality Culture Approach

A perfect world

Just imagine; You have a set of GMP Batch Records describing what needs to be done. Critical GMP actions are double checked. Operators signed off all applicable steps. Deviations from the process are clearly explained. Corrections are signed and dated. Perfect!

Unfortunately, I have to wake you up here. This perfect world is usually far from reality. Even though it all sounds so easy to do, in reality hardly any Batch Record is in perfect shape when it leaves the production area. In earlier posts on batch records we have discussed the regulatory expectations and the process-oriented approach of Batch records. In this post we are going to have a look at the soft skill part; People and Culture.

The importance of people and culture

The people part is just as critical as the regulatory- and process side of things when developing a batch record. How people behave is determined by the culture of the organization. Employees just have to follow the rules, right? I wish it were this simple.

Even though every pharmaceutical organization has to comply with the GMP guidelines, you cannot simply expect people to follow these rules blindly. How people behave is determined by the culture of your organization. The symptoms of this culture may be more subtle than you would expect. It is about how people behave if they are willing to inform you about mistakes.

Leading by example

What people need is to feel safe, that there are no consequences when reporting something that is not ok.The role of (senior) management is very critical. Leading by example is the key aspect to create a constructive working atmosphere.

Only recently I trained a manager that explained the rules to his team and then did the opposite himself. Not trustworthy at all. His underlying message was: I am telling you this. But actually, it is not very important at all.

Leading by example is a prerequisite for a healthy work environment.So as a manager, what message are you sharing with your employees?Next to “Lead by example,” the quickest way to involve employees in properly filling in Batch Records, is a combination of:

  • Good forms to work with.
  • Preventing unnecessary signing and forms should be easy to fill and review.
  • Robust manufacturing process (as described in part 2 of this series).
  • Positive feedback sessions after the batch record review (often between Production and Quality employees).

I have seen many examples of Quality people complaining about the production department: Again they have not properly addressed the deviation, and production employees complaining about Quality: They are making such a fuss. Are your feedback sessions based on appreciation or judgment? Production employees should feel comfortable to share what is not working well and subsequently being supported by the organization.

Focus on the positives

Please realize that only sharing what is wrong is not working at all. It has been scientifically proven that giving compliments is an important key to success. Studies show there is a 6.6% increase in productivity when employees are being complimented for what they do. We all have this intrinsic motivation and like feeling appreciated.

Whereas extrinsic motivators such as warnings or bonuses – are not very effective at all. It is the intrinsic motivation; feeling appreciated, we all would like to have more of. And the result? Honest and constructive positive feedback is what contributes to better quality and accountable personnel.


So to To Make Your Batch Records Foolproof: Build a culture of Leading by example for (senior) management. Design Batch Records according to Good Writing Practices. Design Robust manufacturing processes (see part 2). Train your team to give honest and constructive feedback, focusing on what has been done right.

Even though all four areas contribute to making your batch records foolproof, it is impossible to work on all area’s at the same time. Therefore I would like to invite you to select one or two subjects and start working on those first. Which one(s) would you choose first? I would love to hear your response. Please let me know by leaving a comment below!

Jaap Koster
Jaap Koster

Jaap Koster has 39 years of experience in the pharmaceutical industry in North- and South America, Asia, Africa and Europe. Jaap is the CEO of PCS.

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