I am often called into companies to identify opportunities for improvement in processes, products and also the Quality Management System as well. These projects give an opportunity to learn how an organisation ticks, its strengths and its weaknesses. Often management initiates the process by giving me their list of systems that they believe are broken or at least not operating as efficiently as they would like. But not always.  They want these worked on but sometimes are reluctant to consider the systems they consider working well.  Or maybe these “working systems” are the ones without the loud squeaky wheel attached.  That is, the one flying under the radar and silently deficient.

I usually take these lists and negotiate with the company that I should look broader than those that they have identified.  That is not to create billable hours but rather because of efficiency. While they may have identified some of the deficient systems, they may not have all.  Also it may be that the ones they consider working well are in fact not working well at all or they may have a system with overkill in place.  Now, if there are some very good systems, you can learn a lot about an organisation if you can understand why some are good and others not.  What causes this?  it can be an uneven management or a pocket of progressive people who are 100% dedicated in the face of adversity.

The key is to bring me in once to identify all the opportunities rather than bring me in twice.  It costs more.  It adds months to the timeline if I have to do it twice.

So what do I usually find?  First, management often does have a good perspective of the “bad” systems.  Often they have identified the very painful ones – the ones in dire need of improvement.  But not always.  This has to be teased out by careful interview of process owners and stakeholders and users alike.  In the interview, it is critical that it is the system that is examined and not the person who runs it.  These people are trying their hardest (in most cases), its just the tools, resources and environment that prevents them from running a successful process.  In 90% of the time it’s not people but the environment they are working in that causes the problem.  Most of these organisations are working at 100 mph with compulsory overtime needed to just get the basics done.  There is no time for future thinking, the fires are burning out of control and there are just not enough firemen to keep the place from burning down to the ground.

What I also find are organisations that are reluctant to change.  The last time somebody took a risk and it failed, they were punished.  You can bet the next time they don’t risk going out on a limb.  When I talk with these folk, I often find processes that are unwieldy, overly complex.  It’s not uncommon to see SOPs of 40, 50, 60 pages long.  No wonder there is a deviation at every turn.  These deviations then flood the investigation system.  With a 30 day to complete the investigation and a backlog, what happens next.  Well, they wait to day 28 or 29 because they are working on other things and are caught between a rock and a hard place.  Got to get it completed or I miss my goal of 30 days.  Get it signed off and off my desk and get the CAPA in place.  And what is the CAPA?  It’s usually retrain operator or rewrite SOP.  These are easy to think up and everybody is familiar with these.

And do you really believe that these two CAPAs are going to work and prevent a recurrence?  Absolutely not.  I was auditing a company recently and over 80% of CAPAs were retrain operator or rewrite SOP and that was for a set of recurring issues that did not go away over a 4 year period.  Complacency had set in.  Are we really that bad at training and writing that it does not solve the problem?  Or is the CAPA not directed at the right thing?  I think we all know the answer.

So what is my job?  First to look at systems and get them into three categories.

1. Ones that are clearly deficient – these need major surgery.  Or they may not even be in place.
2. Ones that are overkill – look for ways to back off what is being done
3. Ones that meet the need – they are adequate although they may not be world class or one that you can proudly say are a 10/10 system.  At this stage, if it works at the right level, leave it. It does not have to be perfect.

Category 1 and 2 need the major work. These systems are really tools in a tool box to allow us to operate our business and these tools have lost the vision of what they were intended.  Instead of serving us to help us get the work done, they take on a life of their own.  These tools now control us and make us jump through hoops.

However, as my father once said, “If you can identify a problem, you are 50% on the way to the solution” And that is when the fun begins with getting these overworked people together to look for opportunity to eliminate non-value added work which will free up resources to put on the other Towering Inferno areas.  And its contagious.  Solve a problem once and the next problem is much easier to solve.

It’s these moments I really cherish.  When I see surgery on an overly complex process that brings a breath of fresh air to the people involved, those are the moments I look forward to.  The look in the eyes of the staff is what this job is all about.  And its fun.

Posted in audits, Clinical Manufacturing, Commercial Manufacturing, GMP, News, Quality Management Systems, Risk Management| Tags: Services, SOPs|Leave a comment

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

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.

Posted in Clinical Manufacturing, GMP, News, Risk Management, Webinars| Tags: Services, SOPs|Leave a comment

At a recent webinar I presented for Tungsten Shield on the topic of Lot Disposition, I had an interesting question.  It occurred when I was discussing review of investigation reports and it went like this:

What regulation calls for the Lot Disposition group in the US to review the technical content of an investigation before dispositioning a lot for the clinic or commerce?

And this question was prompted because of the following comments I made.

We all know that the QP in Europe examines all the information, he deems necessary prior to dispotioning a lot – it’s what he is obligated to do by law.  That includes review of the investigation reports related to deviations.  It includes a review for completeness and also a technical review to assure he agrees with the conclusions and the content.  He further assures he understands and agrees with the logic behind the decision.  I contend that in the US, the equivalent person responsible for lot disposition should also review the content to understand the decision to release the material or not and if the investigation is not complete or to his liking, should send it back before moving forward to release the lot.  After all by signing the release, you have made a decision that the lot is acceptable.  Part is to assure the investigation is complete but another part is that the decision is logical and supported by the report.  It is not simply a compliance agreement but a techncial one as well.  During an inspection, he would be asked why he released the lot. And an answer of “the investigation was complete and said so, does not wash”.

The questioner did not get it and responded that no regulation actually required it so why do it.  I responded that when I sign something eg lot release, I am putting my name on the line and am assuring the decision is right.  It is just a good business process.

I sense many people just do not buy into that concept but rather look to the regualtory bodies to tell them what to do rather than develop good business processes.

Posted in Clinical Manufacturing, Commercial Manufacturing, GMP, News, Webinars| Tags: Services, SOPs|1 Comment

I am intrigued by certain webinar companies that appear to spend a fortune on advertising.  You’ve seen their emails and half page ads. They go like this.

What’s the one thing that you can control that is a disaster waiting to happen?  Those piles  of SOP’s fresh off the press that nobody knows what to do with.  Bullet proof your procedures.

You’ve seen the adverts. If only life were that simple.

Actually, writing SOP’s is a relatively easy job if you go about it the right way.

Rolling them out is also simple, again if you do it the right way.  We will talk about these two parts later.

It’s not as if perfect SOP’s are needed and that rolling them out must be done perfectly.

I have audited organisations that had pretty poor but acceptable SOP’s with training programs that are uninspiring and yet these organisation operate in compliance.  Are they efficient  – NO?  Do you want to use their SOP’s and training programs – NO?  But they work and the companies stay out of trouble.

Actually the 800-pound gorilla in the room is really management involvement and support for the principles of compliance which includes following SOP’s and actively training staff.

How can you detect this problem?  It is often detected by looking at regulatory citations and/or audit findings.  Look for those observations that are made with CAPA’s that never seem to prevent recurrences.  Look for repeat observations.  Now look at the CAPA’s.  How many call for a rewrite of one or more SOP’s?  How many call for retraining?

As I always say in my class, if SOP rewrite was the right solution, how come we are so bad at doing it that we have to keep rewriting them?   Time and time again. And the problem does not go away.  Are these rewrites so bad or are we tying to correct the wrong thing?

If training and its roll out was the key issue, how many times do you retrain Bill on the procedure and he just does not seem to get it, before you say that there must be another issue here?

At some point, step back and ask the question, how come these rewrites and retraining do not solve the problem?  The answer is closer than you think.  It is the culture in your organisation.  It is a difficult message to deliver and to receive.  But, as my father used to say, understanding you have a problem is half way to solving it.

Do you allow non-compliance with your SOP’s?  Are they optional in your programs?

The answer to all these issues is to do the following:

1.) Before you write an SOP or review it for rewrite, ask the question of whether the effort is worth your time.  Is there an SOP already in place?  If not, do you really need another?  Only then consider rewriting or producing an SOP.

2.) Make sure you get subject matter experts involved in the writing or at least defining content.

3.) Make sure all stakeholders are involved in reviewing the draft SOP.  Does that mean they all approve it?  NO.  There is an owner and QA who need to approve an SOP.  Perhaps 1 or 2 others, but rarely more, are required.  Too many approvers mean things get log jammed.

4.)  Communicate the new SOP before it goes live so that involved parties can assess and train as appropriate.

5.)   Training does not have to be complicated.  It may mean simply reading and  acknowledging you understand it.

6.)  Give the organisation enough time between issuance and go live.

7.)  Document all activities.

Now the biggy.  Make following SOP’s a requirement for continued employment.  Follow them yourself.  Nothing spells disaster more than a boss that is above SOP’s.  If you do not set an example for following them, you are setting an example that they are optional.

Posted in Commercial Manufacturing, GMP, Warning Letter| Tags: Services, SOPs|Leave a comment