This week, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) finally announced that its new guidance on good practices for data management and integrity for pharmaceutical manufacturers and distributors has come into effect.
This final version is of a draft document originally introduced in 2016 and re-issued as a draft in 2018. It’s been a long road to get final version. Final version here.
Outspoken watchdog group White Coat Waste Project recently released an analysis of nearly 200 new drug applications submitted to the FDA between 2000 and 2020 to describe the impact of animal modeling.
There is litle reason for these tests, and frankly I think we’d all be thrilled to no longer need them. The outdated regulations that drive to mandatory animal testing should be ended.
In the report, the organization took special aim at the use of beagles. Around 11,000 puppies and dogs were used to satisfy the FDA’s testing requirement during that 20-year period. And my puppy definitely not approve. Just thinking of all that wasteful testing puts him to sleep.
As we discuss the future of work, of how we do in-person, remote and hybrid it is critical to think about how modern knowledge work is highly networked and collaborative and benefits from social serendipity through social networks and access to people with complementary expertise. Value is often created in an ecosystemic way and through social networks, and as we determine new ways of working it is important to consider how we will allow social serendipity while at the same time creating flexibility.
Frequent, informal, spontaneous interactions in collocated work environments enable cohesive relationships and increases social awareness. There are four major types of collaboration that stem from social serendipity:
Sharing ideas freely with others for the advancement of the organization
Free exchange of ideas
Working with less experienced colleagues to encourage and support development
Disseminating knowledge and vision
Working with others to solve problems and improve performance
As we evaluate our organizations, build and sustain teams, we should be looking for ways to enhance the ability to have social serendipity, enshrining this as part of our team norms.
Text heavy presentations with few graphics have got to go. Every presenter should have to attend a class on slide structure and build.
A virtual conference platform needs to do 3 things right – closed captioning of recorded presentations and ideally live ones, robust breakout sessions, easy to use chatting. The one used could use some work in all three areas. I would love to have seen a platform that easily integrated with the ASQ app on my phone as well.
There is a very real discussion to be had about the use of the Service Mark in presentations when all someone is doing is using a standard tool (an annotated swimlane is not unique). The ASQ can be accused of being too much dominated by consultant companies and I think balance is important here.
Not understanding the sticking to 4:3 aspect ratio slides. 16:9 is better for conferences and video.
Virtual events are important, they enable inclusion. While I miss face-to-face events I do believe we should have a mix of events going forward. events that are more than passive webinars. So sick of webinars. Looking forward to experiments in making that blend happen. We’re experimenting with a storytelling event in the Team and Workplace Excellence Forum.
We do not have enough people to process the deviations we get
45% of deviations are recurring
You hear this sort of framing regularly. Notice that only the third is a problem, the other two are solutions. And in the case of the first statement it can leave to some negative results. The second just has you throw more resources at the problem, which may or may not be a good thing. In both cases we are biasing the problem-solving process just as we begin.
The third problem statement pushes us to think. A measurable fact raises other questions that will help us develop better solutions: why are out deviations recurring? Why are we not solving issues when they first occur? What processes/areas are they recurring in? Are we putting the right amount of effort on important deviations? How can we eliminate these deviations?
If a problem statement has only one solution, reframe it to avoid jumping to conclusions.
By focusing on a problem statement with objective facts (45% of deviations are recurring) we can ask deeper, thoughtful questions which will lead to wisdom, and to better solutions.
To build a good problem statement:
Begin with observable facts, not opinions, judgments, or interpretations.
Describe what is happening by answering questions like “How much/How many/How long/How often.” This creates room for exploration and discovery.
Iterate on the problem statement. As you think more deeply on the situation modify your first version. This is a sign that you understand more about the situation. This is the kind of data that will join with the facts you discover to lead towards sound decisions.
The 5W2H tool is always a good place to start.
Who are the people directly concerned with the problem? Who does this? Who should be involved but wasn’t? Was someone involved who shouldn’t be?
Roles and Departments
Action, steps, description
When did the problem occur?
Times, dates, place In process
Where did the problem occur?
Why is it important?
Why did we do this? What are the requirements? What is the expected condition?
How did we discover. Where in the process was it?
Method, process, procedure
How Many? How Much?
How many things are involved? How often did the situation happen? How much did it impact?
Remember this can be iterative as you discover more information and the problem statement at the end might not necessarily be the problem statement at the beginning.
Is used to…
Understand and target a problem. Provide a scope. Evaluate any risks. Make objective decisions
Answers the following… (5W2H)
What? (problem that occurred) When? (timing of what occurred) Where? (location of what occurred) Who? (persons involved/observers) Why? (why it matters, not why it occurred) How Much/Many? (volume or count) How Often? (First/only occurrence or multiple)
Object (What was affected?) Defect (What went wrong?)