Theresa Mullin, FDA’s Associate Director for Strategic Initiatives for the Center for Drug Evaluation and Research recently gave a presentation “Update from FDA CDER” at GMP by the Sea (I need to go to that that some-year).
A task analysis breaks down a complex task into its components – the steps involved and the knowledge required. To do a task analysis, you observe the work and interview a subject matter expert (SME) or key performer.
What do you want to identify in a task analysis?
Why someone would learn the skill
Prerequisite skills, knowledge and attitudes
Special materials or tools required
Warnings of dangers, both overall and at specific points in the process
The critical steps (no more than five to seven, otherwise you should split it into another task) and their sequence
Whether the sequence is critical or flexible
Any other steps necessary to complete the task and their sequence
How critical any given substep is
Conditions that must be satisfied before going on to the next step
Reasons for doing steps at a particular point
Signs of success for each step (for confirmations)
Signs of failure for each step
What is the process for doing a task analysis?
Review any documentation, manuals or process maps
Observe at least one expert and take notes as you observe
Either slow down experts during the task to ask questions or interview afterward
Identify each step
Document what you saw and what the expert told you, then ask for the SME’s reaction, there will almost always be gaps identified
Expect the process to be iterative
What should you ask the SME?
What is the SME doing?
Why is it important, or what is the rationale?
Why is the SME doing it that way?
Is there a warning necessary?
How does the SME know what to do next (if there is a choice between two or more actions)?
How can the SME tell if a step was done right?
How can the SME tell if a step was done wrong or incompletely?
How is the sequence critical?
What does the SME do that isn’t documented?
While often viewed from the training perspective, task analysis is a core quality tool that is utilized in procedure writing, automation, user interface development, problem solving and so much more.
Last November, officials from the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) met with industry representatives in London to discuss the various quality challenges that arise when the development of investigational products is accelerated .
The report was recently published, and can be found here.
The workshop discussed process validation, control strategies, good manufacturing practice (GMP) compliance, comparability, stability and regulatory tools of early access approaches. Throughout they discussed two elements:
Scientific which includes technologies and scientific concepts or principles for development, manufacture and quality risk management, which may or not be present or implied in existing guidelines. Examples include concurrent validation, new modelling methodologies, new analytical techniques, etc.
Regulatory/procedural tools are described in the legal, regulatory framework and can be specific to PRIME (or Breakthrough Therapies) (e.g. kick-off meetings) or generally applicable [e.g. Post-approval change management protocols (PACMPs), recommendations, scientific advice (SA)].
I strongly recommend reading the report in it’s entirety.
It is now officially announced. I have volunteered to be the chair of the Team and Excellence Forum for the ASQ.
The Team and Excellence Forum is well placed to develop and provide best practices in the input and process factors, and to develop competencies that the other technical divisions and forums can leverage. Areas such as facilitation, team organization, collaboration and the list goes on. In the last few months I have found myself narrowing in to the Food, Drug and Cosmetic Division for my professional/technical competencies and the Team and Workplace Excellence will be the focus on my interests in social and self competencies.
As the announcement indicates I am currently pulling together a leadership team -we will need to fill at minimum a secretary and chair elect (the chair position for the forum runs through 2021 so I’m not going anywhere) – and folks to build and drive content.
My immediate goals are:
Conduct a voice-of-the-customer survey – need to figure out what topics the membership is most interested in and what content formats (case studies, podcasts, webinars, videos, articles, etc) work best
Build content on the my.ASQ community so it can go public
Create a 2020 business plan aligned to the ASQ strategic priorities (due in September)
An exciting year is ahead. If you are a member of the ASQ and looking for volunteer opportunities, and your interests align with Team Excellence, then drop me an email.