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
Single use components have been used in operations for decades but their use is expanding rapidly. The agencies are taking a closer look. Just published an interesting article on the topic in BioPharmaceutical International . Enjoy the read
Just published an article in Medicine Maker (Medicine Maker article). The focus is to identify when and if a relationship goes south. It identifies the issues and how to avoid getting trapped. Happy reading.
Do you have deviations that just won’t go away? Do they disappear for a couple of months only to reappear a few months later stronger than ever? Have you ever wondered why?
I won’t try to say that there is one cause for this but one that I have found continuously is Human Error as a major cause of the problem. The obvious CAPA for this observation is to retrain the operator and rewrite the SOP. I have seen it often in companies.
When I go in to audit the QMS, this is one area I look for first. I look at the CAPAs and tally up the retrain operator and the rewrite SOP ones and if I find it happens more than 10% of the time, I know where to focus. Investigations are not thorough or in depth.
On a recent visit to a client, they had just exited from a grueling inspection by an agency with a total of 53 observations. They had developed their responses which are really CAPAs in any other language. There were a total of 135 CAPAs and 55% were “retrain operator” or “rewrite SOP”. I asked the person in charge of getting the responses back and asked whether he thought it would correct the problem. His reply was an honest “No, many of these problems we’ve seen before and tried that and it never works”. So, I ask him why are you doing it again, remembering Einstein’s quote “insanity is doing the same thing again and expecting a different result”. At least I think it’s Einstein.
I then asked, “Why did you do this when you know it will not work?” The answer was a chilling “because the regulators will accept it and it will allow me to get back to making product!” I wanted to say “Yes, in the same broken way as before”.
After talking with other people at the plant it became clear that their investigation skills and tools were deficient. They could get to the human error point. They recognized that somebody had made an error but they lacked the tools to investigate further as to why it occurred. Was it a system that was defective, were the operators overloaded with work, were the work stations organized appropriately?
Very rarely is Human Error the root cause but rather Human Error is the symptom of things not functioning properly. It is often the result of a deficiency elsewhere. No other industry accepts human error just our pharmaceutical one.
There are four main ways that that things fail and manifest as human errors. There has been plenty of research in this area but not in pharmaceuticals.
As you read through the examples above, you will see a lot of similarity and overlap and that is because, it is rarely only one of the above that fails. It actually starts at the management level with culture. They set the tone that creates the systems, procedures and people to fail.
So how can you detect that you have a culture problem? A systems problem? Poor procedures? Or people prone to human errors?
You know you have problem or potentially one if you can say yes to any of the following:
Culture Problems include
System problems are evident by these
Procedure problems are exemplified by
Which brings us to People
Of course this is not a comprehensive list but you get the picture!!
To get rid of all these types of problem requires both management and workers to take responsibility. We must move to a culture exemplified by
The road is a long one fraught with challenges but as my father used to wisely tell me “Knowing you have a problem is 50% of the way to solving it”. How true!!!!
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.