Accountability does not go away to be Psychologically Safe

A common and distorted application of psychological safety is that it is somehow a shield from accountability. Non-performing employees tend to invoke it as an excuse for poor performance, insisting that a focus on psychological safety means valuing people and building relationships. That’s true, but stretching the premise, they claim that we should give them a pass when they don’t perform.

The flawed logic seems to be along the lines of because we may have used fear and intimidation, command and control, and manipulative and coercive tactics with people in the past, in an attempt to hold folks accountable, we must shed the artifacts that drive accountability in order to have an environment of psychological safety.

In my experience, this is especially prevalent when discussing metrics around overdue quality systems records and training. How to discuss what is late, can you even publish a list of folks with overdue training?

I want to be very clear, psychological safety is not a kind of diplomatic immunity from having to deliver results. It is not a shield from accountability.

Being held accountable can be looked at as transparency in progress. Psychological safety allows us to be vulnerable and to trust that the organization will take the problems seriously and address them.

Poorly Incentived for Quality

Luis Charles Chavarría recently posted about watches and quality. Reading that, and several of the responses remind how pharmaceutical quality is often just framed in terms of regulatory adherence instead of a broader approach. ISO9001 and other major quality models basically break down to having 8 dimensions of quality.

In a lot of industries, it is very visible to the customer whether quality exists. Shoes, cars, toaster ovens – I can gauge them based on multiple of the criteria above before I buy. I can go on credible review sites, use tools like Consumer Reports, get reliable feedback from others. When a friend recommends a couch, I can trust their opinions.

We have none of that in the regulated areas of pharma and much of medical devices. Patients are prescribed product, and even when there are multiple generics available the only real criteria is price. Chances are the patient barely knows the manufacturer, let alone the manufacturing site. It can be very difficult for a patient, or even doctor, to gauge the quality of the product.

It is for this reason we need more transparency throughout the supply chain, through the development of products. The National Academies of Science, Engineering and Medicine (NASEM) report is a start and needs to be implemented quickly. As a beginning it can really help start to shift the needle and make large parts of this industry more receptive to

Increasing Transparency in Drug/Medical Device Manufacturers

The National Academies of Science, Engineering and Medicine (NASEM) has published a report on resiliency in the medical supply chain that calls for the US Food and Drug Administration (FDA) to publicly disclose the location of all manufacturing facilities that supply ingredients and parts for pharmaceuticals and medical devices approved in the US.

The report recommends FDA publicly disclose information on drug sourcing, manufacturing quality and volume, and capacity for medical products approved for sale in the US.

“The manufacturer for a pharmaceutical drug should be required to publicly disclose the manufacturing location, in particular the FDA Establishment Identifier (FEI), the city, and the country for the finished dosage form (FDF), active pharmaceutical ingredient (API, major excipients, and major packaging and delivery devices for all pharmaceutical drugs sold in the United States,” said a report summary.

The same recommendation also applies to devices; device manufacturers should publicly disclose the manufacturing location in the FEI, the city, and the country involved in the device’s manufacturing and final assembly.

The report also recommends FDA make its risk-based site selection model scores publicly available. Wow, not only would that be good for consumers, I’d love to know where my sites fall in on that scoring.

Hurry up and put this recommendation in place!

Transparency is a good thing and it is shown to increase consumer safety. It is a problem that even a fairly knowledgeable industry professional like myself cannot figure out where generics are manufactured without making a few phone calls and shaking down my friend network. And even then, I’m never positive that I understand where my family’s medicine is coming from and the status of the sites involved in manufacturing and distributing the product.

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.

Transparency

Transparency in organizations generally falls into one of two categories: proactive and demand-driven.

Proactive dissemination refers to information that the organization’s leadership makes known about its activities and performance. Practical expressions can range from strategic and tactical goals, third-party evaluations, and organizational risks.
Demand-driven access refers to an organizational commitment to respond to employee requests for specific kinds of information or documents which otherwise would not be accessible.

The idea of transparency can also be unpacked in terms of its directionality. Disclosure cuts both ways, channeling information upwards as well as downwards in the organization. Leadership sharing insight into decisions is an example of downwards, where idea management processes are upwards.

The type of transparency also matters:

Opaque or fuzzy transparency involves the dissemination of information that does not reveal how organizations actually behave in practice, whether in terms of how they make decisions, or the results of their actions. The term also refers to information that is divulged only nominally, or which is revealed but turns out to be unreliable.
Clear transparency sheds light on organizational behavior, which permits interested employees to pursue strategies of constructive change.

This distinction between clear and opaque is grounded on the premise that if transparency practices are going to meet their goals of transforming organizational behavior, then they must be explicit in terms of who does what, and who gets what.

Transparency requires not only a willingness, but processes to drive it.