It is critical to carve out the time to develop and challenge oneself, to listen to external exertise and to share with peers. You cannot wait for others to make the time for you to engage in learning.
An alternative way to look at uncertainty is offered by Klir, which adds discord to the mix.
Work-As-Prescribed can be a real avenue for all three of these uncertainties. But by using risk management to examine the possibilities of these uncertainties we can truly interrogate. This is one of the things we mean by risk management and knowledge management being bound at the hip as enablers.
To do this we need to make sure that:
There is the management of information quality. Management of information quality is crucial in risk management because uncertainty is prevalent. Uncertainty, as a state for which we lack information, means that uncertainty analysis should play an integral part in risk management to ensure that the uncertainty in the risk management process is kept at a feasible level.
There is explicit management of either existing knowledge that can be applied to improve the quality of the analyses or to improve the knowledge acquired in the process that can be used in the follow-up process. Knowledge management is pivotal to ensuring an effective risk management process by providing context and learning possibilities. In essence, risk management is not just about managing risks – the entire context surrounding the risks must be understood and managed effectively.
Jargon is something we should work hard to avoid, and yet there is an awful lot of it we find difficult to let go. Right at the top is the GxPs.
GxP is a general abbreviation for the “good practice” quality guidelines and regulations. The “x” stands for the various fields, including the pharmaceutical and food industries, for example good manufacutiring practice, or GMP.
There are a lot of GxPs, though we tend to focus on 5(ish), depending on where you are.
We tend to argue a lot about them. Even to the GxP vs GXP. Or GPvP vs GVP. Or GdocP or GDP (so damn confusing, there is another GDP – Good Distribution Practices). Or if Good Storage Practice is its own body or part of the GMPs and GDPs. And…and…and.. The arguing can be fun.
The Five big ones in pharma and medical devices are GLP, GCP, GMP, GDP and GPvP. Some of the others like GACP are pretty intesting in their application.
Some like GDocP and GAMP are more specific threads that go across the GxPs.
By nature the GxPs are tied to the phase of the pharmaceutical pipeline.
The GxPs are all about ensuring compliance and are informed from a wide range of sources, starting with law and regulations.
Being in the age of globalization, there are many many sources to draw from.
This can also draw from beyond the health authorities (for example in the US USDA for GACP or the DEA for parts of the GDPs).
At the end of the day, GxPs answer to five important criteria.
In the current world scenario, which is marked by high volatility, uncertainty, complexity, and ambiguity (VUCA), threats are increasingly unforeseen. As organizations, we are striving for this concept of Resilience.
Resilience is one of those hot words, and like many hot business terms it can mean a few different things depending on who is using it, and that can lead to confusion. I tend to see the following uses, which are similar in theme.
The property of a material to absorb energy when deformed and not fracture nor break; in other words, the material’s elasticity.
The capacity of an ecosystem to absorb and respond to disturbances without permanent damage to the relationships between species.
An individual’s coping mechanisms and strategies.
Organizational and Management studies
The ability to maintain an acceptable level of service in the face of periodic or catastrophic systemic and singular faults and disruptions (e.g. natural disasters, cyber or terrorist attacks, supply chain disturbances).
For our purposes, resilience can be viewed as the ability of an organization to maintain quality over time, in the face of faults and disruptions. Given we live in a time of disruption, resilience is obviously of great interest to us.
In my post “Principles behind a good system” I lay out eight principles for good system development. Resilience is not a principle, it is an outcome. It is through applying our principles we gain resilience. However, like any outcome we need to design for it deliberately.
We gain resilience in the organization through levers that can be lumped together as operational and organizational.
The attributes that give resilience are the same that we build as part of our quality culture:
In 2023 I start my leadership cycle through the Food, Drug and Cosmetic division, starting as chair-elect. This means time to do some content creation! Here’s the first thing I have planned.
The Food, Drug, and Cosmetic Division will be hosting a poster share on February 28th from 3-5 pm in Boston, with a cocktail hour afterwards (5-6). The event is being sponsored by Veeva Systems and will be free (big shout out to Veeva!)
We are looking for individuals and companies to share a poster on the theme of “What are you proud of in your eQMS? What about your implementation or continued use stands out and that you want to share?”
If interested in presenting a poster, please complete this form.
We ask that all posters be completed by the 22nd of February so we can get them printed.
We will record the poster presentation and make them available through my.ASQ after the event. Poster presenters must sign a standard ASQ waiver (we will make it available before the event).
An event sign-up will come out in January.
The event is open to all. While I’m thinking the focus will be heavily focused to FD&C and medical device members, other quality professionals will get value.
So please present a poster! I am very excited about this sort of sharing of ideas. I want to keep experimenting with alternative ways to share information and network, and I think the old poster session is something that has renewed utility in this day-and-age. Sort of a speed conference. Easier to create a poster and can be a compact event.