Now is a good time to be active in a professional organization

Many of us are wondering just how we are going to get through the next few months of self-isolation. I’d like to recommend getting active in a professional organization.

Amazingly enough this can be a good time to strengthen your network, further your career or maybe even build some friendships. Professional organizations can enhance your personal and professional development and provide endless networking opportunities. Look around your community—there are bound to be a plethora of organizations (from small local start-ups to national chapters) for you to join.

A professional association can your professional home. It is the place where people in the same field will come to know you, support you, and nurture your growth and development. Especially now for those of us who are self-isolating, our professional associations can mitigate the potential isolation and loneliness of our work. There’s nothing quite like sharing in the excitement of learning about new understandings and techniques with others who share the challenges and the joys of the profession. There’s nothing quite as supportive as a group of people who have “been there and done that”. There is nothing quite like sharing your own experiences and hard-won lessons.

Like I said above, there are a lot of professional associations out there. I belong to a plethora of industry (PDA, RAPS), subject area (ACMP, PPA) and domain (ASQ). Right now my heart is certainly fully committed to the ASQ and the Team and Workplace Excellence Forum, but you do you and find the organizations that work for you. But if you need help navigating the ASQ, or are looking for opportunities to get involved, let me know.

So what can you be doing right now to leverage a professional organization? Especially right now? I think there are four major areas to look at:

Colleagueship: Associations are the primary way that people do face-time networking with people who share our professional interests. Most organizations are offering a lot of online options to make it possible to network with people all over the world. Get your face out there and build those connections. And when we can all get together again, keep at it.

Education: We’re in a rapidly changing field. It can take years for good research to make it into print. Now is a great time to catch up and then stay up to date and knowledgeable about new trends in the field. Take an online course. Ask questions.

Information: Association journals, bulletins and newsletters, websites and mailing lists are often the first place that new developments in the field are published. Many associations use their media to alert their members to more than research. Articles and news items also inform us about changes in governmental policies, new trends and other issues that impact the field.

Career Development: Engage in education offerings. Now is a good time to work on that certification. Eventually there will be opportunities again to attend conferences and present a poster or workshop, but right now heavily use the forums and other tools to get that experience of sharing your work and develop your credentials. Further, associations often have listings of job opportunities that are only available to members.

Above all, Stay Inspired and Stay Motivated.  Love what you do! It is important to be proactive about things you discover on the journey. Get out there, post, ask questions, answer questions, read and then share what you are reading.

In the routine of remote working you are building, now is a great time to make a habit of blocking off a little time in your calendar to go online and contribute. For fellow ASQ members I hope to see you at my.ASQ.

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 BandlerPatricia 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 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?