ASQ TWEF UnConference

I’m organizing a mini UnConference for the ASQ Team and Workplace Excellence Forum.

A survey for logistics and attendance is here.

An UnConference, otherwise known as a OpenSpace or BarCamp, is a tool I’m a huge fan of. They can really serve to generate action and build energy, commitment, and shared leadership with a group by unleashing self-organization. The idea is to make sure that ALL of the issues that are most important to the participants are raised, included in the agenda, and addressed, making it possible for participants to take responsibility for tackling the issues that they care about and for what does or doesn’t happen

Which makes it a great tool for the Team and Workplace Excellence Forum to really generate some activity. If you are interested please respond to the survey above.

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.

FDA Foreign Drug Establishment Inspections – Congressional Testimony

Subcommittees of the House Committee on Energy and Commerce heard testimony last week from the Government Accountability Office’s Mary Denigan-Macauley and from Janet Woodcock, Director of FDA’s Center of Drug Evaluation and Research, about the state of FDA’s foreign drug establishment inspection program.

Deborah L. Livornese “Testimony About FDA’s Foreign Drug Establishment Inspection Program: GAO and FDA See Things Differently but Both Would Like to See a Fuller Glass.” FDA Law Blog. 16-Dec-2019

Good summary of recent testimony on FDA inspections outside the USA, especially China and India.

MHRA on Passing the Baton from GPvP to GMP

I love the MHRA Inspectorate blog. They don’t write often, but when they do, good stuff. Here are some of my thoughts on the post on moving patient safety data from determination as part of the pharmacovigilance efforts to labeling to distribution.

Starting in the Good Pharmacovigilance Practice (GPvP) realm, triggers for updates may be identified by pharmacovigilance staff and the corresponding variations submitted by regulatory affairs staff, who will also receive notification of variation approval. At this stage Good Manufacturing Practice (GMP) processes come into play with arrangements for printing the updated leaflets and incorporating these into the supply chain.

MHRA Inspectporate Blog “Passing the baton from GPvP to GMP: Three top tips for protecting patients and staying compliant ” 17 Dec 2019

Unless otherwise stated, updates to patient information leaflets should be introduced within 3 to 6 months of approval” – this is the critical point stressed in this post. The recommendations given in the blog post are solid.

Blog RecommendationThoughts
Check that the end to end process facilitates the timely implementation of updates and that there is seamless transition from written procedures covering GPvP, regulatory affairs and GMP processes. Labeling is often a separate change control process. Integration and simplification in change management is critical and companies should look seriously at balkanization of systems.
Define what is meant by ‘implementation’ of an updated leaflet and make sure this is in advance of regulatory deadlines to prevent the need for batches being re-worked should there be any unexpected delays Effective dates on changes need to take into account deadlines.

Appropriate linkages to ERP and supply chain systems.
Ensure the QP has access to up to date information on the correct leaflet version that should be used at batch certification. Communication, and the use of integrated change management

I also read this morning Teresa Gorecki’s post “Dedicated, Integrated Quality Assurance Systems Critical to Successful Clinical Trials.” All of her points are highly relevant here.

Teaching Quality People to Listen

Been thinking a lot on what a training program around teaching people to listen and not to talk might look like and how it fits into a development program for quality professionals.

People in quality think a lot on how to make a reasoned argument, a good decision, to provide guidance, get their point across in meetings, persuade or coerce people to follow standards. This is understandable, but it has a cost. There is a fair amount of research out there that indicates that all too often when others are talking, we are getting ready to speak instead of listening.

I think we fail to listen because we are anxious about our own performance, concerned about being viewed as an expert, convinced that our ideas are better than others, comfortable in our expertise, or probably all of the above. As a result we get into conflicts that could be avoided, miss opportunities to advance the conversation, alienate people and diminish our teams’ effectiveness.

When we really listen we create the spaces to make quality decisions. Listening can be improved by these practices:

Ask expansive questions. Stay curious, build on other’s ideas are mantras I think most of us are familiar with. Suppress the urge to interrupt or dominate a conversation and concentrate on the implications of other people’s words. It is very easy for a quality professional to instantly leap to solving the problem, and we need to be able to give space. Focus on open-ended “what” and “how” questions, which encourage people to provide more information, reflect on the situation and feel more heard. Avoid yes-and-no questions which can kill dialogue.

Engage in “self-checks”. Be aware of one’s own tendencies and prepare with ways to identify they are happening and head them off. Doing this will surprisingly allow you to focus on the listener and not yourself moving beyond the words that are being said and being able to take in the speaker’s tone, body language, emotions and perspective, and the energy in the conversation.

Become comfortable with silence. This means communicating attentiveness and respect while you are silent.

Listening needs to be part of our core competencies, and unless we work on it, we don’t get better.