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.

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.

Toyota is a horrible exemplar

Just like the immense sins of Jack Welch and GE will always tarnish six Sigma it is past time to realize that the conservative, looking backwards to Toyota of much of Lean thinking is a mistake that limits adoption and more importantly innovation.

As a company there is much at Toyota that is just wrong. The 2020 recalls were significant, but frankly not the first year the company has been having major quality contorl issues.

But more important is the fact the company is a liar and a supporter of authoritarianism. As a promponent of the pillars of Lean thats just damn hypocritical. After the failed coup of Janaury 6th, Toyota pledged to no longer fund anyone who supported the attack against US democracy. As of June they are the top fundraiser to those Republicans, giving to nearly a quarter of the 147 GOP politicians who objected to certifying the election results.

Toyota is showing us who they are. A company that stands apart from the principles so important to the Quality profession.

Quality Profession Needs to Stand for Quality in Public Practices

The Quality profession either stays true to its’ principles and ideals, or it is useless. We either support transparency and driving out fear or we don’t. Then we become the shallow, and dangerous crutch of demagogues and tyrants. One of the reasons Six Sigma has immense problems it still has not successfully grappled stems from how it is centered on the tyranny of Jack Welch.

The ASQ’s Government Division has taken a great step recently by endorsing the adoption of ISO/TS 54001:2019 “Quality management systems — Particular requirements for the application of ISO 9001:2015 for electoral organizations at all levels of government”.

We should be demanding elections built on the foundations of good quality. This should be part of electoral reform requirements at the Federal level. We need to oppose attempts to restrict voting. We need to drive fear out of our electoral system.

The United States is a signatory of international standards of policing. And yet no state follows those standards. Federal law needs to respect our treaty obligations and impose these standards, and we need to hold states and localities accountable.

As a quality professional I spend the day figuring out how to truthfully measure results. Yet an entire party has gleefully adopted lies and disinformation. I strive to democratize leadership, to build a culture of psychological safety. And yet all around us we see demagoguery.

Our workplace cultures are influenced greatly by external factors. We cannot hope to drive lies and fraud out of our systems, to create cultures of safety, to build excellence when all around us is a disregard for those standards. For this reason the quality profession must be political. It must standard for truth, for fair standards applied equitably. For driving out fear.

Ensuring our practices are linked to science

There is a lot of poor to outright bad science in business, leadership and quality circles. We also have a tendency to place anecdotal evidence over objective.

Here are some of the ones I am always on the look out for, on a “horrible to I can live with it” scale. It is by no means an exhaustive list. I tried to avoid “fads” as that is a debatable set.

Myers Brigg (MBTI)

Corporate astrology, pure and simple. Once I see this, I know everything that comes after it is problematic. Books and books have been written on how useless this is. So stop it already.

Learning Styles

The research is definitive. There is no such thing as a learning style and focusing on them is basically a waste of time and will distract you from actually creating valuable training content.

70:20:10 Rule

This is no rule. It was a guideline thrown out on the fly and because of the nice round numbers has become widely used. No empirical evidence supports it in any way. The only study of any repute, a 2003 study by Enos, Kehrhahn and Bell actually showed completely different ratios – 16% from experience on the job, 44% from learning from others, 30% from formal training and a leftover 10% that they couldn’t quite define. But those aren’t round and cool sounding.

It doesn’t even work as a general principle, it is too rigid to be of any use and doesn’t (again) represent how people learn and do work.

Triune Brian

This is just outmoded, the idea that we have a lizard brain has been show to be wildly inaccurate. There are just way better models. Also, the way it is used in most contexts we can just cut it out and not have a loss. It’s time to see this outdated model retired from good in quality circles. The tool using crows will be less likely to plot our demise.

Nonverbal communication

Unfortunately, although thousands of peer-reviewed publications provide very important insights on the impact of nonverbal communication in social interactions, we are exposed to a plethora of false beliefs, stereotypes, and pseudoscientific techniques to “read” nonverbal behaviors. Frankly, I just assume that whatever is being presented is mostly untrue and work from there.

Brainstorming as a crowd

Group driven brainstorming has reducing value and we are better off utilizing brain writing activities.

Case Studies

I love reading about other’s experience, and do enjoy a good case study. However, the belief that case studies of successful (or unsuccessful) organizations present valid advice is not a conclusion that has been tested, and can create an illusion of causality. This constructivist sensemaking is useful, but we should always be careful in drawing wider parallels or establishing ‘facts.’ Call it the ‘Wisdom of Teams’ effect if you want to engage in a little drawing of the illusion.

Similar reasons exist to be careful of benchmarking, which is all opinion and no science.

Employee Engagement

There is little to no evidence that any of the vague concepts of employee engagement actually improve productivity or even that any interventions will actually raise the scores. The only thing proven about employee engagement is the number of hours folks spend on it.