Guidances have been issued by the FDA and EMA for over three years now. So are companies complying or are they finding it tough? Read an article I wrote in Contract Pharma Article. Happy reading
You’ve heard of it. You’ve probably experienced it. You may even have survived it. Yes, I am talking about “Project Operations Excellence”. Don’t get me wrong. The principles behind it are very good, even admirable. The premise is that we are operating presently as a result of processes that have evolved over time. A Band-Aid here, a Band-Aid there. The result is a set of processes that are inefficient not targeted to the customer and to be honest often counterproductive, sometimes counterintuitive. It does not sound good, does it?
Wouldn’t it be wonderful if we could deconstruct our processes and start again? That is what these companies sell you. The promised land of operations that are logical, lean (which brings me to another element of this concept, but I’m not getting drawn into that now – hint it suffers some of the same issues), lacking in superfluity, less is more, you get my drift.
So you sign on the dotted line and then in come the saviors. Most often it’s not the A team that did the sales pitch, the Dog and Pony show but if you are lucky it’s the C or D team. A couple of people who’ve seen the inside of an operations for a couple of hours together with a band of neophytes, fresh out of MBA school. They know the jargon, are excellent at powerpoints (I think that is one of the majors), the theory is at their command. Practical experience gained from case studies, that never go wrong.
Don’t I sound cynical and negative? No actually, I am not cynical or negative. I did not expect anything else. I’ve been through this exercise 5 or 6 times at different companies using some of the industry best companies and I’ve seen it at some of the companies I consult with. The problem is that we are our worst enemies. We do not challenge these saviors with data or facts or our experience. Just because they conclude something, does not mean it’s the best idea. It is an idea that should be considered. But often in these short 30 minute interviews to gather their data, they do not gather all the right information, they do not ask the right questions. Often it seems like they have gone in to these companies with the answer and are gathering data to support the results.
An example that came up recently, when talking with a client, related to an operational set up of a piece of equipment. On first glance, it appeared that after the equipment was set up, and then it was checked twice before using. The saviors immediately pointed out duplication and eliminated the second assessment. Nobody asked the question of why there were two checks. The junior person being interrogated did not have the answer. Voila, the step was removed. It was only afterwards, that a more senior person with experience of when the second check was put in place, that the explanation was clear. This piece of equipment had a tendency to drift in setting and the second check just before use was to monitor whether it had or not.
Perhaps the first check could have been removed? But that was never asked. An A team member with good process experience might have caught that one.
Modern day root cause analysis contends that silver bullets do not exist. Rather it is a series of events (each incapable of causing the problem themselves) align and it is this alignment that causes the event. So often we end up with corrective actions which are several to improve each element.
Is this example given an isolated incident? I contend no, because I have been into many companies reeling from these assessments. In fact one company that is in regulatory trouble now can trace their decrease in performance in operations, to an Operations Excellence episode. The results of the study were taken as gospel and implemented blindly. Clearly, all were at fault. An incomplete analysis, and accepting everything as correct etc.
So I caution everybody to think through how you manage an Operations Excellence project.
Remember that these people coming in to assess do their work and leave. They do not have to operate with what they leave. They are like a flock of seagulls, they fly in, squawking, leave you a present (hint, it is not paper) and fly off. What you should be looking for with an Operation Excellence is a team to evaluate, propose solutions and help you implement. And make sure you get the A team.
During the last couple of months I have been working with a company that is undergoing a transition as products move through their pipeline – quite a radical shift in strategy. Over the years, their Quality Management System (QMS) has evolved. But as with all evolution, the small incremental changes that occur might lead along a path to an improved system or an evolutionary dead end. With this radical shift, they invited me to come in and assess what they are doing right, what they are doing badly and what, perhaps, they are not doing.
So the first step is a gap analysis which entails reading documents and records and interviewing people. Fortunately, management is highly supportive of this exercise so I got extreme cooperation from all parties. Documents (SOPs policies, quality manuals and quality plans) were supplied to illustrate the systems. In addition, I requested records which were supplied readily. These included deviation investigations, CAPAs and change controls, to name just three types. While I cannot look at all, I asked that typical examples be shown. I want to see the average type record – neither the best nor the worst. During discussions, which ranged from 1 on 1s to small groups, people felt comfortable describing what they liked and what they found frustrating. The interesting feature I noted was that the same frustrations were felt universally across the organization. It did not matter whether it was QA, QC, engineering or production: all felt the same.
The analysis revealed that the three systems described were all weak. While the company used an electronic system to track and manage the system, the end result, the reports, did not meet the requirements of either the practitioners or me. That is, they were neither well written nor clear. They lacked the clear logic to explain what had happened and why for deviations, how the CAPAs linked back to the deviations and the rationale for the change in the change controls. And why was this? In a way the people involved had treated their systems as hurdles that had to be overcome to move to the next step, rather than the tools they should be. With the e-system, it appeared the goal was to move the document from their inbox to next person’s inbox.
They had lost sight that an investigation’s goal should be to:
In this case, the e-system had done a grave disservice to the company. It had taken the thinking out of the process; it had subverted the process from serving the operations to a system that had to be served. It had also driven behavior into short term thinking versus long term. They had cultivated a fire-fighting mentality.
The exact same thing had happened in the change control system. There was not a critical evaluation of any of the changes. The changes were made to save materials rather than build a rugged process or system.
To combat this systemic problem (and all three areas were linked), we embarked on a training session. It included three elements
During the second round, there was a breakthrough by one of the staff members. Suddenly, the light bulb went off. I have never seen such an excited person in all my years training. I am going back in a couple of weeks to see how things are going. I am quite optimistic. I will keep you posted.
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.
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;
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.