Author: Jeremiah Genest

Quality professional with over 20 years of experience. Gamer and storyteller with forty years of practice.

Detectability in Risk Management is a “Sort of” “Sometimes” thing

I’ve recently seen a few audits that point out something along the line of “Recommendation to revise Quality Risk Management Process/Procedure to include detectability as a variable in determining Risk Priority Numbers (RPNs).  The current process only includes the frequency and severity of impact in the calculation.  However, ICH Q9 also recognizes the use of risk management tools which include the ability to detect harm (detectability) in the estimation of risk (refer to the section titled “Risk analysis”).”

So, first of all, that’s not what Q9 says. Q9 (R1) is actually pretty clear here, stating “Risk analysis is the estimation of the risk associated with the identified hazards. It is the qualitative or quantitative process of linking the likelihood of occurrence and severity of harms. In some risk management tools, the ability to detect the harm (detectability) also factors in the estimation of risk.”

Q9 later goes on to state “Quality risk management supports a scientific and practical approach to decision-making. It provides documented, transparent and reproducible methods to accomplish steps of the quality risk management process based on current knowledge about assessing the probability, severity and sometimes detectability of the risk.”

Q9 clearly recognizes that detectability is useful sometimes, with specific tools in specific cases. This is in alignment with risk management thinking in general, for example ISO 31000:2018 states that Risk analysis should consider factors such as:

— the likelihood of events and consequences;
— the nature and magnitude of consequences;
— complexity and connectivity;
— time-related factors and volatility;
— the effectiveness of existing controls;
— sensitivity and confidence levels.

Detectability is then one of several methods to consider in risk analysis. The selection criteria for tools should take into account situations when detectability is desired and drive to use of those tools, for example, the FMEA which is built to determine how and when a failure can be detected. In other tools, detectability is usually built into the evaluation of current controls and is often captured in likelihood or somewhere else

When it comes to risk, avoid a one-size fits all. Think of what the intent is and use the right tool for the job.

ASQ FD&C Boston Poster session – 28Feb2023

Yesterday the Food, Drug, and Cosmetic Division of the ASQ hosted a poster session on the question “What are you proud of in your eQMS? What about your implementation or continued use stands out and that you want to share?”

This was our first try and it also happened in one of the few winter weather events we’ve had this season in Boston, but I was incredibly pleased by the turnout and the five posters were all superlative.

I was actually so busy that the only photo I remembered to take was this one, which was actually 10 minutes before our official start time.

There were five posters:

I thought each of the posters brought a different bit to the conversation, and wow were there a lot of conversations going on!

I definitely learned that next time I need to get recorded talks from folks. I had originally planned this, but it didn’t happen mostly because I was just too involved in talking about my poster.

I want to say an immense thank you to our very gracious hosts Veeva Systems, who provided a great spot and a whole lot of hospitality. Will Gould was great to work with and really went above-and-beyond as a host.

With the great attendance and the on-the-site feedback, definitely planning on doing this again. A quick survey to gauge interest and help select a topic is here: https://forms.office.com/r/rUf7VRE6Dy

Day 2 New Rules for Work

Due to a host of issues (work, my inability to be an early morning riser), I had a late start today. I appreciate the conference having events across time zones, and there are a few sessions I hope I get back to watch the videos.

Current and Future Risks of Travel, Meetings, and Humanity with Bruce McIndoe and Loren Edelstein

Given I went into the office last week and got a bad cold (I tested multiple times) this may be a topic I’m thinking of.

Starting heavy on the weather is critical. Folks still aren’t putting enough into the growing impact of weather.

I’m not an event planner, but as an individual who spends a lot of time thinking about risk management and contingency, thoughts on the weather, transportation, and pandemics are of constant thinking.

Kind of veered off into futuristic thinking.

3 Cs of Culture No matter Where People Are by Wayne Turmel

Wayne’s books are great, I am definitely getting his new one. His model for innovative cultures resonates well with the concept of quality culture.

Using Consent-Based Decision-Making to Launch Complex Initiatives into Action by Lynn Handy, Annette Gregory-McArthur and Shannon Scott

Consent based decision making has 2 questions to answer

  1. Is it good enough for now?
  2. Is it safe enough to try?

Progress over perfection.

I don’t think we discuss consent nearly enough in quality decision-making.

Making better, faster decisions that are good enough for now | by Bonnie Slater | Humans of Xero | Medium

Then work happened and I missed a lot of sessions some of which I will watch the videos of

The New Logic of Work: A Smarter Vision for Hybrid by Nathan Coutinho

Let’s hear what Logitech wants me to be thinking about for hybrid work. Quick look around my work space shows I have a fair amount of their equipment.

I rather enjoyed this presentation. Learned a little on ergonomics but what I really liked was a round up of current technology offerings.

Day 1 Afternoon- New Rules for Work Symposium

A Door Opens – Making Space for Innovation facilitated by Keith McCandless and Nancy White

“Notice and stop counterproductive behaviors that stifle creativity and innovation”

I felt they struggled to explain the concept of a TRIZ and the breakouts struggled to have an impact as a result. In hindsight, it was definitely a bit of my coming at the methodology a little too vigorously from my quality background. So a bit of an learning moment for me.

I’ll be contemplating this picture for weeks. There was a lot to absorb.

The NeuroScience of Teaming by Dr Michael Platt and Elizabeth Johnson

Start with the need to make time to socialize with coworkers at work. Back to the idea of fun.

Good relationships are critical in business. Finding ways to connect is critical for well-being. We are wired to connect.

The need to practice our social networking and skills. I feel that these days, so often I feel out of shape here after the last few weeks.

Our attention is one of the aspects of our neurobiology we have control over and through attention we can prioritize what our brain processes.

All about meeting structure comes back to managing attention. Discusses how eye contact causes processes in brain that link to team work and trust, and how this is an engineering challenge.

Importance of breaks.

All comes back to building relationships. I was interested in there is causal evidence here around synchronizing as a biomarker.

Perspective taking – shifting frame of reference to someone else’s.

Impact of the hierarchy on perspective taking. It’s not good.

Importance of empathy.

Facilitated Mixer: An Abundant Exchange

Fun experiment with 3 assumptions

  1. Visuals make everything easier to remember
  2. Small groups make valuable conversations easier
  3. We can create benefits that live beyond this workshop

Love the concept that the act of receiving help and knowledge is part of our being generous towards our peers. Thinking of abundance and applying it in professional development is a favorite topic of mine.

Deliberately thinking of what abundance I have that may help others fill their needs, and sharing what challenges I need help on was a powerful way to end my day.

Day 1 Morning – New Rules for Work Symposium

This will be my rough notes of the symposium.

Events should always walk-the-walk. What are we told we need to do?

  1. Ensure everyone understands the purpose, the desired outcome, the manner of interaction
  2. Cover the technology. Make sure there is room for mistakes and what to do when it happens
  3. Engage people early and often

The symposium started strong here. And it was great to see so many excited individuals ready to engage.

How to Unlock Creativity Through the Power of Play – Charlie Hoehn

Steve Job (or in this case Steve Jobs adjacent) anecdotes are usually a way to make me groan a little. The guy was not a good person to emulate. And anyone now associated with Tesla is probably someone I don’t want to meet.

I like the Stuart Brown quote of the “Opposite of play isn’t work it’s depression.”

Stresses the key of enthusiastically saying yes. Of co-workers as playmates and work as play.

We played storyspine.

Freedom, mastery and connection – three elements required for play.

Okay, people stop referencing JK Rowling! She’s a horrible person and does not deserve our attention.

Useful exercise a play history. What activities did growing up and did for fun. Jot them down and those are what you were intrinsically motivated to do. I did that here a while back – Story is critical, or why tabletop roleplaying made me the quality professional I am today – Investigations of a Dog (investigationsquality.com)

  1. Work is play
  2. Co-workers are playmates
  3. Office is a playground

If a leader refuses to be vulnerable and play it never feels right. Always an air of eggshells and fear.

Joy Bond – Psychological Safety

Be willing to play the fool

Delivering happiness.com – help for ROI discussions

  1. What stands in the way of you and team feeling safe to play?
  2. What activities would allow you to “play the fool” around your co-workers?

All work and no play leads to culture of fear. Leads to burnout.

Ways to make office creative

  1. Walking meetings
  2. Company outings during work
  3. Company potlucks during work
  4. Contests during work
  5. Playful cues with no obligations to use them

RECESS – The act of stepping away creates creativity

Great question – how do we incentive play in the workplace.

Started kind of weak (and I resicovered my dislike of quoting) but very valuable session. I’ll read his work.

When Virtual Communication Might Curb Creativity – Dr Melanie Brucks

“Can we collaborate when interact on-line”

Shared environment and visual focus and the influence on divergent thinking and convergent thinking is pretty interesting. The mimicking of experiences.

The rating scale for creativity is fascinating. Something we talk about a lot in idea management. Need to followup on this.

Great science dose to start thinking about creativity and work.

Understanding the Power of Environmental Space on Creativity, Collaboration, and Innovation – Matt Chadder

Environmental space capturing attention is a critical thing for design of workspace. I’m shocked we aren’t talking about this more in Lean circles.

I need to read more about this. There’s something deep here for GxP spaces and human error reduction.

Rest spaces – the company cafeteria – as the number one place to manage stress. Looking forward to discussing that in a continuous improvement issue. No surprise hospitals are Matt’s reference.

Environmental spaces to reset culture (3-4 days to seed the new behavior)