Amazon’s lack of safety culture

Time after time, internal documents and interviews with company insiders show, Amazon officials have ignored or overlooked signs that the company was overloading its fast-growing delivery network while eschewing the expansive sort of training and oversight provided by a legacy carrier like UPS.
“Inside Documents Show How Amazon Chose Speed Over Safety in Building Its Delivery Network” by James Bandler, Patricia Callahan and Doris Burke, ProPublica, Ken Bensinger and Caroline O’Donovan, BuzzFeed News
Dec. 23, 3 p.m. EST

Great reporting on the purposeful decisions that led to an unsafe culture. I recommend everyone reading this.

“Those interviews, as well as internal documents, reveal how executives at a company that prides itself on starting every meeting with a safety tip repeatedly quashed or delayed safety initiatives out of concern that they could jeopardize its mission of satisfying customers with ever-faster delivery.”

It all starts with leaders walking-the-walk and paying more than lip service to principles. “delighting the customer” is a great goal, but there are other stakeholders, and employee safety is a higher principle.

This article really reinforces my opinion that while there may be useful tools we can learn from FAANG companies, by-and-large their cultures do not appear ones truly dedicated to safety, quality and excellence.

It bears repeating. If we made pharmaceuticals the same way Amazon or Facebook operated, we’d all be dead. Every-time I read about Alphabet getting involved in healthcare I become petrified. One only has to look at the safety record of Tesla (both in the factory and the safety of it’s automobile) to start feeling worried on what happens when you take the bad culture from Silicon Valley and apply it to other endeavors..

Yes…but…and

We have all had the first rule of brainstorming, “defer judgment,” drilled into us for years. The general rule of “When a person proposes an idea, don’t say, ‘Yes, but…’ to point out flaws in the idea; instead, say, ‘Yes, and…’” which is intended to get people to add to the original idea, has become almost a norm in business settings. We have all become improv actors.

That truism is probably not a good one though. It can lend to a fairly superficial approach. Yes we need to be beyond “Yes, but”, but “Yes, and” stifles creativity. The concept of “Yes, and” gives an illusion of moving forward, avoiding conflict, but also prevents truly diving in and exploring issues.

We need to combine the best aspects of criticism and ideation, “Yes…but…and.” I propose idea A, a colleague first addresses what she perceives to be a flaw in it, provides constructive feedback (this is the “but”), and then suggests a possible way to overcome or avoid the flaw, yielding Idea B (this is the “and”). Then you do the same: You acknowledge Idea B, provide a constructive critique, and develop a new, even more improved result. Others can jump in with their critiques and proposals during the process. This kind of constructive interaction encourages a deep cycle of critical dialogues that can lead to a coherent, breakthrough idea.

Here are some things to keep in mind:

When you see a weakness in the idea, don’t simply say, “This does not work.” Rather, first explain the problem and then propose an improvement that would make it work.
When you do not understand the idea, don’t simply say, “That’s unclear to me.” Instead, first point to the specific spot that is unclear and then propose possible alternative interpretations: “Do you mean X or Y?” This helps all participants to see more detailed options
When you like the idea, do not just take it as it is. Instead, search for possible improvements and then push forward to make it even better.
When you listen to someone’s critique of your idea,try to learn from it. Listen carefully to the critique, be curious, and wonder, “Why is my colleague suggesting this contrasting view that is not in line with what I see? Perhaps there is an even more powerful idea hidden behind our two perspectives.” The critique becomes a positive force, focusing the team on overcoming its weaknesses and enhancing the original idea.

Good decisions require creativity. But flexing our practices we can drive that in our interactions.

System failures are rarely due to the employee

Between January 2016 and May 2019, you recorded approximately 397 customer complaints related to container closure issues (e.g., approximately 60%), product separation, lack of effect and adverse events. Your quality unit failed to adequately review these complaints, identify trends, and implement effective CAPAs. During the inspection you explained that these lapses in quality system performance were due to underperforming staff, who had since been dismissed. In your response, you attributed these and other quality related issues to under staffing of the quality unit as your business expanded.
Your response is inadequate because you failed to appropriately address your quality unit not performing their required duties. Your firm must provide the quality unit with the appropriate authority, sufficient resources, and staff to carry out its responsibilities to consistently ensure drug quality.
FDA Warning Letter to Teligent Pharma, Inc. dated 26-November-2019

Continuing the trend of making me petrified about generics, this warning letter is a roller-coaster read. One big set of failures is to actually investigate and apply appropriate resources to the quality unit. And then the management had the gall to blame the employees.

80+ years of quality principles ignored. I personally thought the FDA was being overly nice.

There are basically three questions to answer:

Do you have a properly established, staffed, and managed Quality Unit?
Does your Quality Unit have appropriate responsibilities and authority?
Does your Quality Unit have access to the data it needs to make informed decisions?

New Report Exposes MBTA’s “Questionable” Approach to Safety

A “debilitated” safety department and too-thin maintenance crews are just two of the revelations surfaced by a new report on the MBTA’s safety culture.
Read on www.bostonmagazine.com/news/2019/12/09/mbta-safety-report/

Let’s cut right to the heart of the report’s recommendations:

“The panel makes six policy recommendations that are intended “to move the organization to a place where safety is a priority and is culturally integrated into every aspect of their mission.” They include establishing better safety performance indicators, identifying the areas where maintenance is being deferred, implementing stronger data collection, and strengthening the MBTA’s leadership team with “more seasoned” transit professionals.“

Where does that seem familiar?

Leverage the CPGP for Quality Maturity

The ASQ’s Certified Pharmaceutical GMP Professional Certification is under-valued. The ASQ really needs to step up and place itself in the forefront of quality culture and maturity, utilizing this certification, as a center-piece. I don’t think there is really a comparable certification on the market and I am continually puzzled why there has not been more adoption.

Let’s break down the ten-points in the St Gallen’s FDA Quality Metrics project and how they link to the body of knowledge behind the CPGP.

Optimized set-up and cleaning procedures are documented as best practice process and rolled out throughout the whole plant.

Cleaning is pretty strong within section IV, Infrastructure: Facilities, Utilities, Equipment, starting with C. Equipment which includes:

Equipment layout. Determine the layout of equipment to minimize the risk of errors, to facilitate effective cleaning and maintenance, and to avoid contamination or any other undesired effect on product quality. (Apply)
Equipment cleaning and maintenance. Review procedures and schedules for equipment cleaning, maintenance, and, where necessary, sanitization to ensure that they meet requirements. (Apply)
Equipment cleaning validation or verification. Evaluate the need and methodology for product-contact cleaning validation and/or verification. (Evaluate)
Equipment change control. Verify that change control has maintained the qualified state of equipment. (Apply)

And section F, General Cleaning, Sanitization, and Sterilization Systems

Cleaning procedures. Review cleaning procedures in accordance with cleaning validation, whenever validation is required and performed. (Apply)
Sanitization procedures. Review sanitization procedures for facilities and equipment, and ensure all are in accordance with any required validation studies, including details on cleaning schedules, methods, equipment, materials, sanitizers, disinfectants, sporicides, and sterilants. (Apply)
Pest control. Review and verify that a pest control program is in place and that it uses authorized rodenticides, insecticides, fungicides, fumigating agents, and appropriate traps for pest elimination. (Apply

A large percentage of equipment on the shop floor is currently under statistical process control.

Section VIII. Product Development and Technology Transfer, is strong here, though I recommend that section IV, Infrastructure: Facilities, Utilities, Equipment have material added here.

For root cause analysis, the firm has standardized tools to get a deeper understanding of the influencing factors for problems.

Section II, Quality Systems. The ASQ is strong in root cause analysis, and this is one of those areas where thinking of the CPGP as a industry specific to add to a problem solving certification pathway. Subsection F. “Investigations and Corrective and Preventive Action (CAPA)” covers this well with:

Trigger events. Identify events that require: investigation, root cause analysis, and impact assessment both directly and indirectly related to the event. (Evaluate)
Response actions. Define immediate action, corrective action, preventive action, management responsibility, and methods of implementing them. (Evaluate)
CAPA feedback and trending. Describe how CAPA trending is used to modify appropriate quality system elements. (Create)

Goals and objectives of the manufacturing unit are closely linked and consistent with corporate objectives and the site has a clear focus.

Operational controls and monitoring is throughout the CPGP. This is also a great tie-in with the CMQ/OE.

Manufacturers have joint improvement programs with suppliers to increase performance.

Section 2, K Supplier and Contractor Quality Management breaks this nicely down into Supplier Quality Systems, Supplier Controls and Supplier Evaluation.

All potential bottleneck machines are identified and supplied with additional spare parts.

Section 4, C 1 Equipment planning which covers “Equipment planning Review equipment location, design, construction, installation, and maintenance based on the operations to be conducted. (Apply)” and 3 Equipment cleaning and planning “Review procedures and schedules for equipment cleaning, maintenance, and, where necessary, sanitization to ensure that they meet requirements. (Apply) “

For product and process transfers between different units or sites,standardized procedures exist that ensure a fast, stable and compliant knowledge transfer.

Section VII Product Development and Technology Transfer covers this very thoroughly.

Charts showing the current performance status such as current scrap rates and current up times are posted on the shop floor and visible for everyone.

Discussed throughout the body of knowledge is operational controls and failure rates.

The firm regularly surveys customers’ requirements.

Not explicit in the body of knowledge. Much stronger in other certifications, such as CMQ/OE. Probably a good area to get added.

The firm ranks its suppliers and conducts supplier qualifications and audits.

Section 2, K Supplier and Contractor Quality Management breaks this nicely down into Supplier Quality Systems, Supplier Controls and Supplier Evaluation.