Author: Jeremiah Genest

Quality professional with over 20 years of experience. Gamer and storyteller with forty years of practice.

The Great Man Fallacy and Pharmaceutical Quality

Primary Investigator, Study Director, Qualified Person, Responsible Person – the pharmaceutical regulations are rife with a series of positions that are charged with achieving compliance and quality results. I tend to think of them as a giant Achilles heel created by the regulations.

The concept of an individual having all the accountability is nowhere near universal, for example, the term Quality Unit is a nice inclusive we – though I do have some quibbles on how it can end up placing the quality unit within the organization.

This is an application of the great man fallacy – the idea that one person by the brunt of education, experience, and stunning good looks can ensure product safety, efficacy and quality, and all the other aspects of patient and data integrity of trials.

That is, frankly, poppycock.

People only perform successfully when they are in a well-built system. Process drives success and leverages the right people at the right time making the right decisions with the right information. No one person can do that, and frankly thinking someone can is setting them up for failure. Which we see, a lot in the regulatory space.

Sure, the requirement exists, we need to meet it failing the agencies waking up and realizing the regulations are setting us up for failure. But we don’t need to buy into it. We build our processes to leverage the team, to democratize decisions, and to drive for reliable results.

Let’s leave the great man theory in the dustbins where it belongs.

dissolving crown

Building the Risk Team

Good risk assessments are a team effort. If done right this is a key way to reduce subjectivity and it recognizes that none of us know everything.

An effective risk team:

One of the core jobs of a process owner in risk assessment is assembling this team and ensuring they have the space to do their job. They are often called the champion or sponsor for good reason.

It is important to keep in mind that membership of this team will change, gaining and losing members and bringing on people for specific subsections, depending on the scale and scope of the risk assessment.

The more complex the scope and the more involved the assessment tool, the more important it is to have a facilitator to drive the process. This allows someone to focus on the process of the risk assessment, and the reduction of subjectivity.

GMP mistakes are costly

In the continual saga of companies making fundamental GMP mistakes, Gilead has recalled two lots of its coronavirus treatment drug Remdesivir because of the “presence of glass particulates.”

If only there existed international standards on visual inspection and there were a solid set of best practices on lyophilization.

Oh, wait there are.

But then Gilead has a multi-year track record in deficiencies in their testing and manufacturing processes. In all fairness, they are contracting manufacturing to Pfizer’s McPherson site…..oh wait that site got an FDA 483 in 2018 specifying significant violations of good manufacturing practices, such as an inadequate investigation into the detected presence of cardboard in vial samples.

We deserve better manufacturers. Companies need to take the quality of their products seriously. We are always improving or we are always one step away from the sort of press Gilead gets.

Is-Is Not Matrix

The Is-Is Not matrix (proper name Kepner-Tregoe Problem Specification Statement) is a great tool for problem-solving, that I usually recommend helping frame the problem. It is based on the 5W2H methodology and then asks the question of what is different between the problem and what has been going right.

ISIS NOT
WhatWhat specific objects have the deviation? What is the specific deviation?What similar object(s) could reasonably have the deviation, but does not? What other deviations could reasonably be observed, but are not?
WhereWhere is the object when the deviation is observed (geographically)? Where is the deviation on the object?Where else could the object be when the deviations are observed but are not? Where else could the deviation be located on the object, but is not?
WhenWhen was the deviation observed first (in clock and calendar time)? When since that time has the deviation been observed? Any pattern? When, in the object’s history or life cycle, was the deviation observed first?When else could the deviation have been observed, but was not? When since that time could the deviation have been observed, but was not? When else, in the object’s history or life cycle, could the deviation have been observed first, but was not?
ExtentHow many objects have the deviation? What is the size of a single deviation? How many deviations are on each object? What is the trend? (…in the object?) (…in the number of occurrences of the deviation?) (…in the size of the deviation?)How many objects could have the deviation, but do not? What other size could the deviation be, but is not? How many deviations could there be on each object, but are not? What could be the trend, but is not? (…in the object?) (…in the number of occurrences of the deviation?) (…in the size of the deviation?)
WhoWho is involved (avoid blame, stick to roles, shifts, etc) To whom, by whom, near whom does this occurWho is not involved? Is there a trend of a specific role, shift, or another distinguishing factor?
Is-Is Not Matrix

The Kepner-Tregoe Problem Specification Statement, sometimes referred to as the Is-Is not matrix is reprinted with permission by Kepner-Tregoe, Inc.  © Copyright 1965 – 2023, Kepner-Tregoe, Inc. All Rights Reserved.

Harvard Business Review – Whitewashing business executives is their core business

In the latest edition of “Executive utilizes Harvard Business Review to whitewash their activities” we have Hubert Joly, CEO of Best Buy, who informs us that we should all

  • Making meaningful purpose a genuine priority of business operations
  • The “human magic” of empowered and self-directed employees
  • Admitting you don’t have all the answers is a sign of strong leadership.

Let’s see how Best Buy puts those practices in place.

It is hard to take the editors of HBR seriously when they discuss what a good company culture looks like when they whitewash corporate leaders with this sort of track record.

Probably Best Buy paid a lot of money for the reputation bump just before Christmas.