What makes a GMP-Compliant `Quality Culture´?
Promoting and fostering an adequate Quality Culture is a GMP-Requirement. The European Medicines Agency (EMA) requires this to assure data integrity, and so do WHO and PIC/S. And it does not matter whether GMP-inspectors make a big deal of this currently or not: It is a clear enough expectation in the GMP-Now and Here.
Quality Culture is about “Quality” but is not quality. It is about “Culture”, but is not “Culture” in its original sense.
What Quality Culture is NOT about:
- It is not about being nice to each other in a GMP work environment so nothing bad will happen. or so noone ever feels offended
- Not about having either a Eurpoean or a North American or any other particular cultural way of running a company – although these things really do(!) impact quality!
- Quality Culture is not displacing Management´s Responsibility to lead or exercise authority over staff.
- It is not the same as general “Company Culture” – although it is part of it.
So What is Quality Culture about, when it Comes to the GMP-Regulatory Texts?
First things first: If You want to do it well, look at what is expected in the GMP-regulatory texts, do not look at the website of Your favorite GMP-lobbyist. Look at the texts!
The main reason why this term has become more prominent recently is that quality culture is supposed to add to Data Integrity and Quality Oversight. Not because of bad equipment, not because of bad processes – but because of the human factor. And this comprises a bunch of aspects that come with… (for added information see also WHO Guidance on Good Data and Record Management Practices):
- Poor GMP quality system understanding,
- Poor understanding of the personal responsibility of each individual employee regarding GMP and drug quality,
- A lack of willingness or trust to report GMP problems and mistakes,
- A lack of being heard when reporting such issues,
- Being blamed personally for an issues that one reports,
- A fear of being reprimanded for pointing out misbehavior of employees or of superiors
Who is responsible for driving Quality Culture?
Here is what the EMA says about Quality Culture in the context of data integrity:
“Promotion of a quality culture together with implementation of organisational and technical measures which ensure data integrity is the responsibility of senior management.“
EMA Guidance on GMP: Questions and Answers, 2016).
So the key role falls to Senior Management, and this clearly hightens the expectation of Senior Management involvement in generating and even approving actual GMP-relevant documents(!).
How is Quality Culture driven i.e. promoted by Senior Management?
For this EMA does not specify more details, but PIC/S does (careful when PIC GMP are mandatory in Your company context). Here is what they suggest:
“Management can foster quality culture by:
- Ensuring awareness and understanding of expectations (e.g. Code of Ethics and Code of Conduct);
- Leading by example, management should demonstrate the behaviours they expect to see;
- Being accountable for actions and decisions, particularly delegated activities;
- Staying continuously and actively involved in the operations of the business;
- Setting realistic expectations, considering the limitations that place pressures on employees;
- Allocating resources to meet expectations;
- Implementing fair and just consequences and rewards that promote good cultural attitudes towards ensuring data integrity; and
- Being aware of regulatory trends to apply “lessons learned” to the organisation.”
PIC/S Draft Guidance PI-41 Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments, 2018.
It is quite interesting to see that these are mostly expectations that are actually not that easy to implement in an effective and provable manner, in a documented manner. This would require a rather extensive mechanism for measuring the quality culture and reacting upon feedback. Senior Management is responsible for this and must do it! And here the system of Quality Management Review (QMR) comes into play. It is not a secret that this QMR system is not used to its real potential by many GxP-companies. Quality Culture or its degree could become a new and important QMR section.
How important is Quality Culture in Reality?
To a considerable fraction of companies which we get to see, quality culture is not a known concept. Some of this thinking may be present here and there, but even these bits and pieces are not systematically intended, but highly depend on some temporary circumstance such as a good department leader for a given preriod of time, or some recent positive company developments that transpire into certain parts of the business and its employees. A systematic approach to infuse a GMP company with quality culture as described above is practically non-existent in the vast majorty of companies. In some situations this can be the true root-cause for quality failures and even patient harm. It may be an elusive root cause, but it is a reality.
Aside of now being an official GMP-requirement: In our experience, an intentional promotion of quality culture really makes a key difference in companies with a still developing documents and records landscape. Also where processes and methods are maybe not quite as robust as they should be (also a reality).
The true factor to success of quality culture is the people You employ. As subjective as this may sound – yet it is not totally subjective! You will need to rely on “character” of Your employees. And it will take down-to-earth people skills to recognize such individuals. And most importantly: Fake-character leaders are found out quickly – employees and even the most uneudcated line-workers are not stupid – they know when someone means quality or fakes it – especially as a leader. And the damage in the employee´s behavior is massive. A following in terms of quality-behavior must be acquired(!), must be earned by personal credibility. And this takes time to build.
Bottom line: Quality Culture means, that earning money with pharmaceuticals just got very much more “moral”! And on a personal note: I (author) quite like that.
Es informiert Sie:
Dr. Dietmar Gross
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