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The third Part of our series on QbD and Quality Continuous Improvment

September 24th, 2017 by

We are happy to announce the publication of the third part of our series.  This article, co-authored with colleagues Dr. Ko and Dr. Stein covers how to create a sustainable continuous improvement program with an emphasis on QbD.  Happy reading.  The link is https://www.pharmaceuticalonline.com/doc/how-to-catalyze-sustain-continuous-improvement-in-pharmaceutical-operations-0001 

 

Part II of article “Big Data & Leadership Strategies For Enabling Quality By Design”

August 29th, 2017 by

Part 2 of a series of articles about Pharma implementation of new regulations and quality systems is out and available for viewing at a number of sites including Pharmaceuticalonline.com  Happy reading.

How well has the pharma industry implemented regulations?

February 25th, 2017 by

This has always been a question people ask.  As a consultant i see a slice of the industry that interacts and works with me, so I have my opinions.  However, a company that employs me may not represent the average company.  So a colleague of mine, Peiyi Ko, and I decided to conduct a survey asking these questions.  we used Survey Gizmo as the survey tool and LinkedIn Groups as the interface.  These 40 questions were posed and because of the interesting answers we got, we are publishing them in two parts.  This post has the first part published in Pharmaceuticalonline.  In this part, we examine the implementation of various guidances and regulations.  The second will feature how ell they have impacted the company Quality Management System.

The second part will be published in a couple of months.  Bookmark my website so you will see it when the next is posted.

Happy reading

Single use components in biopharm – a regulatory perspective

February 4th, 2016 by

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

Operation Excellence strikes again

July 9th, 2015 by

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.

  1. Don’t assume that their answers are right – they are suggestions.
  2. They only get a snap shot of what is going on
  3. If you don’t ask all and the right questions, the answers may not be right.
  4. You are the ones who know what you do and why.

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.