One of the clients of a colleague of mine is undergoing a culture change in their operations from the “old-style” quality to a newer style.  What do I mean by that?  The old style is characterized by the Silo mentality, the us versus them, distrust, Quality that can be characterized as a Dr. No approach.  I think you know what I mean.  You may have worked at a company like that in your career.  Actually you can see them and the results in warning letters posted by FDA if you have never experienced this before.  Although all do not end up with warning letters.  Many operate for years this way.

This will be a long journey involving a lot of small steps.  It is not something that happens overnight.

To embark on this type of transformation requires several elements

1. A detailed knowledge of how they work and where there is opportunities for improvement.  A simple gap analysis and interviews (not an audit) will give you the answers you need.  The important thing is that you need management support for the change.  In the interviews, you need the employees to open up and speak honestly.  I pledge that management will see the results of the interviews but not who said what.  It will be sanitized (made anonymous). Trust has to be there.
2. You must have a good interview skill.  If you have gone through Kepner-Tragoe training you are well on the way.  The key is to keep asking why.  If you have kids, you know what that is.  It’s the 6 year olds approach to learning. “Why is xxxx daddy?”  You answer and they respond “Why is YYYY daddy?”
3. You must listen and think how all the outcomes link back to behavior which then links back to the systems that are not working or are in need of improvement.
4. And above all Management support for the change.  They have to understand why the old will not sustain them and the new might and they must create a blame-free culture where speaking out is the norm.

It reminds me of the old realty axiom.

Its all about

Location, Location, Location.

here it is

Management, Management, Management

 

It is these system failures that help you solve things and change culture.  Pick a key system that is not operating well (and everybody knows which ones they are), create a team of owners and customers and start a discussion forum for all to articulate the frustrations.  Don’t let it get to a simple whining event.  List the issues and ask how we might do it differently.  Let each articulate with asking the rest to see if they have contributions.  Facilitation skills are critical at this stage.

These suggestions can then be used by the system owners to revamp the process.  Get the stakeholders in on the review.  The first rendition will not be perfect but I bet it’s better than what was there.

So what is the new Quality style?

Its where Quality is

• Value added
• A facilitator 95% of the time
• Encouraging of partnering
• where user-centric systems, processes, documents are the norm
• where team based approaches are encouraged
• consulted to solve problems.

As you begin the make the changes, it is essential to get to the point where old habits are delearned and new ones embedded.  It is aided when training becomes education and the HOW and the WHAT are alongside the WHY in the training.  People understand why the change has to happen and they buy off on it because they understand why doing it the old way is not as good as the new.  They understand it because they are part of the solution. It was their idea.  They understand the consequences of their actions.  They take ownership.

This is just the beginning.  Watch for more blogs on next steps.  The successes and the set backs.

By the way, the client’s ship has left the harbor.  The captain has charted a new course (and its in the right direction) and the crew are all pulling in the right direction.  Will it be plain sailing?  I doubt it!!  There will be storms and other testing events but the foundations are strong and they are determined.  Tune in to see chapter 2.

So do you see any of the warning signs in your company?  If so, you might want to drop me an email and let’s see what we can do!!!!!!

Posted in Commercial Manufacturing, GMP, News, Quality by Design, Risk Management| Tags: Services, SOPs|Leave a comment

The initial draft of the EU Guidance for Process Validation was released for comment and the comment period closed in October. So what has the thoughts on the new guidance since it was released? Read the linked article in Master Control on line journal for some insights.

Posted in Commercial Manufacturing, News, Process Validation, Quality by Design, Risk Management| Tags: Services|Leave a comment

In February I published an article on the topic of Quality by Design as it applies to the Vaccines World. This was based on a presentation at an IBC conference on vaccine development. As you might imagine, QbD has been slow in development of biologics but even slower in Vaccines. Check out the article on the IBC website

Posted in Clinical Manufacturing, GMP, Process Validation, Quality by Design, Risk Management| Tags: Services|Leave a comment

At a recent webinar presented by Tungsten Shield on the topic of the differences between Clinical Manufacturing and Commercial, one question perplexed me.  It went something like this:

You advocate using less resources to release a commercial lot of material than a clinical lot and you point to Risk Management techniques.  Surely, the commercial lot represents more value to the company and so shouldn’t you spend more resources?

My response went this way.

In the case of a commercial product where you are making the product round the clock, turning out perhaps a 100 lots a year, you expect operations or manufacturing to be highly experienced in making the product.  They have tremendous experience.  They should not be making mistakes.  The QA department are seeing lot packages continuously and know the weak points and strengths of the process, departments testing etc so know where the risks are.  Now the clinical lot, is probably very unique, maybe only made once and never the same twice since the process is changing.  Similarly, the testing is evolving. The documentation is changing and evolving.  So we do not have the history with the material. Add to that the lack of knowledge about the product particularly in early phase.  All of these add up to a higher risk of issues especially to the patient.  While the commercial lots do represent high value to the company, the clinical lots represent the future for the company where errors can result in products not making it through the clinic or causing delays in clinical programs and let’s not forget the impact on patients.

The questioner seemed fine with the response.

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There has been a lot of discussion at conferences and on LinkedIn as to whether QbD is just for big Pharma and Biotech and whether smaller companies are being discriminated against.  This triggered me to write an article for Metric Streams, GXP Lifeline.  Enjoy

Posted in Clinical Manufacturing, Commercial Manufacturing, News, Process Validation, Quality by Design, Risk Management| Tags: Services|1 Comment