The Calcott Consulting Blog:
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.
- Ones that are clearly deficient – these need major surgery. Or they may not even be in place.
- Ones that are overkill – look for ways to back off what is being done
- 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.
There appears to be a continual debate as to where we need to set the bar for quality and compliance in the Pharma industry. There are a number of strategies I have seen over the years but they all fall into the following in reality;
- We will meet what the regulations tell us – no more, no less – it’s what is required.
- We will exceed what the regulations say – they are minimum requirements – it will give us a business advantage over our competitors.
- We will not meet the requirements to save money and if we get caught we will pay the price. It is the cost of doing business.
You can probably guess which your company fits into. If not, it might be worth thinking this through because, if they have a different strategy than the one you are comfortable with, it might be a frustrating place to work.
The logic, I believe, these strategies use is the following:
The higher we raise the bar, the more cost it is to operate!
But is that hypothesis true? Does it cost more to operate higher on the curve? I contend – not necessarily so.
This came out when I was teaching a course on the cost of quality recently and one of the attendees was arguing that in their business, margins were small so everything they spent on quality was directly from the bottom line. Spend more and profits go down.
While this appears logical on the surface, I do not believe it tells the whole story. It assumes that money spent on quality to raise the bar is simply an overhead and does not impact anything else. In other word, spend money on quality and it has no impact on efficiency or losses etc.
Rather, I believe that if you spend money on quality systems, it will result in decrease cost of operation, higher throughput in the plant and will lead to a more efficient operation. One example might be to improve the way investigations are performed. This should result in more efficient and effective investigations. This results in true root causes being identified and hence more effective CAPAs which lead to less repeat deviations. The improved investigation system would require less resources to operate, be done quicker and hence cost less. And if the investigation actually got to the root cause the CAPA has a higher probability to prevent repeat observations. That is to name just one system. You could construct scenarios for complaints, change control, lot disposition and validation with similar conclusions. I believe investing in quality improvements (raising the bar), should be viewed as an investment rather than an overhead.
It took about three days in the class before the proverbial light bulb went off in his head. I don’t know if he will take that message back to the plant and even if he does, will they believe and introduce some of this thought process into their operations. Time will tell.
During a recent webinar I gave, hosted by Tungsten Shield Group, on the topic of Cold Chain storage and shipping, I was asked a question by an attendee. It went this way:
Should I validate the shipping or can I just put a temperature monitor in? What do the regulations require?
This question was interesting on two fronts:
- Do we do things to please regulators? and
- what is the purpose of validation versus verification?
I personally treat regulations as wisdom handed to us by regulators to help guide our thinking. So I tend to turn the question of “what do regulations require?” into
What are the regulators trying to tell us?
I believe the decision to validate or put a temperature monitor in should be driven by what makes sense from a scientific / logical perspective and a business perspective as well. The regulations are simply telling us that shipping can be risky and can put the drug into jeopardy. Do what you can to prevent problems from occurring and if not fully possible, at least understand if there is a problem.
So in the case of road shipment (or air for that matter), there are measures you can take to protect the product. I recommend the following logic
- Validate what makes sense – the shipping container can be validated to hold product for x hours and an outside temperature of y degrees. But what happens if the shipment takes longer or is exposed to temperature above the range in the validation?
- For things that can not be validated, put controls or measures to minimize the risk or at least measures to tell you if there might be a problem. In this example, you can not really validate the operation of a refrigerated truck. So the measures you put in place are to assure the operation runs smoothly or at least you know what went wrong. That might include training of the driver on the critical elements, having a contingency plan in place if the truck breaks down or loses refrigeration etc.
- For those areas where you want more assurance, you can add a temperature monitor as well to tell you if things were outside the validated ranges. The data then becomes critical in assessing whether you should use the materials or not.
So what might trigger the use of a temperature monitor in addition? If the product is valuable or in short supply, you want to know if it’s still OK. That makes good business sense. Similarly, if it is a clinical product, the risk to the trial results of using a suspect material is just too high. I would include a temperature monitor so if an excursion of time or temperature occurred, I would have data on the condition of the product to justify using it or not.
From my perspective, I would prefer to delay a patient getting a clinical drug, especially in a Phase 3, until I was sure the material was acceptable than blindly dosing with a suspect drug where the conditions were unknown.
It’s been about 1 year since the FDA issued its Guidance on Contract Manufacturing. Based on what I read in blogs and social media like LinkedIn, I am sure not all companies are really up to speed. At an IBC conference recently, I presented a paper on the guidance and putting it into practice. It was so well received, I was asked to write an article on the topic by Bioprocessing International and here it is. Good reading!!