PIC/S on Change Review and Effectiveness

Starting from the end, let’s review some of the requirements in the new draft PIC/S guidance.

Prior to change closure

RequirementImportant Points
Changes meet their intended objectives and pre-defined effectiveness criteria. Any deviations from those criteria are adequately assessed, accepted and managed/justified. Whenever possible, quantitative data are leveraged to objectively determine change effectiveness (e.g. statistical confidence and coverage).Clearly delineating what effective means as a date is critical to generate data.

CQV activities can tell you if the intended objective is met. Effectiveness reviews must be made up of:

Sufficient data points, as described in the implementation plan, gathered to a described timeline, before an assessment of the change is made.

The success criteria should be achieved. If not, reasons why they have not been achieved should be assessed along with the mitigation steps to address the reasons why, including reverting to the previous operating state where appropriate. This may require the proposal of a subsequent change or amendment of the implementation plan to ensure success.

Data and knowledge gathered from implementation of the change should be shared with the development function and other locations, as appropriate, to ensure that learning can be applied in products under development or to similar products manufactured at the same or other locations
As part of the quality risk management activities, residual risks are assessed and managed to acceptable levels, and appropriate adaptations of procedures and controls are implemented.These are action items in the change control.

As part of the closure activities, revise the risk assessment, clearly delineating risk assessment in two phases.
Any unintended consequences or risks introduced as a result of changes are evaluated, documented, accepted and handled adequately, and are subject to a pre-defined monitoring timeframe.Leverage the deviation system.

Prior to or after change closure

RequirementImportant Points
Any post-implementation actions needed (including those for deviations from pre-defined acceptance criteria and/or CAPAs) are identified and adequately completed.If you waterfall into a CAPA system, it is important to include effectiveness reviews that are to the change, and not just to the root cause.
Relevant risk assessments are updated post-effectiveness assessments. New product/process knowledge resulting from those risk assessments are captured in the appropriate Quality and Operations documents (e.g. SOPs, Reports, Product Control Strategy documents, etc.)Risk management is not a once and done for change management.
Changes are monitored via ongoing monitoring systems to ensure maintenance of a state of control, and lessons learned are captured and shared/communicated.Knowledge management is critical as part of the product management lifecycle.

Lessons learned are critical.

ASQ Technical Forums and Divisions as Knowledge Communities

I have been spending a lot of time lately thinking about how to best build and grow knowledge communities within quality. One of my objectives at WCQI this year was to get more involved in the divisions and technical forums and I, frankly, might have been overly successful in volunteering for the Team and Workplace Excellence Forum (TWEF) – more on that later when announcements have been made.

Stan Garfield provides 10 principles for successful Knowledge Management Communities. If you are interested in the topic of knowledge management, Stan is a great thinker and resource.

PrincipleThoughts for ASQ Divisions/Technical Forums
Communities should be independent of organizational structure; they are built around areas upon which members wish to interact. The divisions and technical forums are one part of the organizational structure of the ASQ, but they tend to be more on the knowledge generating side of things. The other major membership unit, sections, are geographical.

Divisions and forums are basically broken in two categories: industry type(s) and activity band.

The Food, Drug, and Cosmetic or Biomedical are great examples of industry focused (these are by nature of my work the only two I’ve paid attention to), and they seem to be very focused on product integrity questions.

The activity bands are all over the place. For example in the People and Service technical committee there is a Quality Management, Human Development and Leadership and a Team Excellence Forum. Those three have serious overlap.

It is of interest to me that the other divisions in the People and Service technical committee are Education, Healthcare, Government, Customer Supplier and Service Quality, which are much more industry focused.

And then there is the Social Responsibility division. I have super respect for those people, because they are basically trying to reinvent the definition of quality in a way that can be seen as anathema to the traditional product integrity focused viewpoint.

There is still so much to figure out about the TCCs.
Communities are different from teams; they are based on topics, not on assignments. Easy enough in the ASQ as this is a volunteer organization.
Communities are not sites, team spaces, blogs or wikis; they are groups of people who choose to interact. As the ASQ tries to develop my.ASQ to something folks are actually using, this is a critical principle. The site pages will grow and be used because people are interacting, not drive interaction.

Ravelry seems like a great example on how to do this right. Anyone know of any white papers on Ravelry?
Community leadership and membership should be voluntary; you can suggest that people join, but should not force them to. Divisions are voluntary to join, and people get involved if they chose to.

Please volunteer…..
Communities should span boundaries; they should cross functions, organizations, and geographic locations. The ASQ has this mostly right.

The industry focused communities are made up of members across companies, with a wide spread of locations.
Minimize redundancy in communities; before creating a new one, check if an existing community already addresses the topic. The ASQ hasn’t done a great job of this. One of my major thoughts is that the Quality Management Division has traditionally claimed ownership of the CMQ/OE body of knowledge, but frankly a good chunk of it should be between the Team Excellence and Human Development divisions, which between them seem to have a fair bit of overlap.

Take change management, or project management, or program management. Which one of the three divisions should be focusing on that? All three? Seems a waste of effort. It’s even worse that I know the Lean Division spends a fair amount talking about this.
Communities need critical mass; take steps to build membership.The major dilemma for professional associations. Love to see your suggestions in the comments.
Communities should start with as broad a scope as is reasonable; separate communities can be spun off if warranted. I’m going to say a radical and unpopular thought. If the ASQ was serious about transformation it would have dissolved half of the divisions and then rebuilt them from scratch. Too many are relics of the past and are not relevant in their current construction. Do you truly need a Lean and a Six Sigma forum? A Team Excellence and a Human development (and a quality management).Should biomedical (medical devices) be part of the FDC?
Communities need to be actively nurtured; community leaders need to create, build, and sustain communities. To do this community leaders need training, coaching and mentoring. I’m happy with the connections I’ve started building in headquarters and with a certain board member.

Perhaps one of the focuses of the Team and Workplace Excellence Forum should be to help push the praxis on this.
Communities can be created, led, and supported using TARGETs:
Types (TRAIL — Topic, Role, Audience, Industry, Location)
Activities (SPACE — Subscribe, Post, Attend, Contribute, Engage)
Requirements (SMILE — Subject, Members, Interaction, Leaders, Enthusiasm)
Goals (PATCH — Participation, Anecdotes, Tools, Coverage, Health)
Expectations (SHAPE — Schedule, Host, Answer, Post, Expand)
Tools (SCENT — Site, Calendar, Events, News, Threads).
Okay. So much here. But this helps me build an agenda for a forthcoming meeting.

I may be jumping the gun, but if you are a member of the ASQ and interested in contributing to the Team and Excellence Forum, contact me.

Self Awareness and Problem Solving

We often try to solve problems as if we are outside them. When people describe a problem you will see them pointing away from themselves – you hear the word “them” a lot. “They” are seen as the problem. However, truly hard problems are system problems, and if you are part of the system (hint – you are) then you are part of the problem.

Being inside the problem means we have to understand bias and our blind spots – both as individuals, as teams and as organizations.

Understanding our blind spots

An easy tool to start thinking about this is the Johari window, a technique that helps people better understand their relationship with themselves and others. There are two axis, others and self. This forms four quadrants:

  • Arena – What is known by both self and others. It is also often referred to as the Public Area.
  • Blind spot – This region deals with knowledge unknown to self but visible to others, such as shortcomings or annoying habits.
  • Façade – This includes the features and knowledge of the individual which are not known to others. I prefer when this is called the Hidden. It was originally called facade because it can include stuff that is untrue but for the individual’s claim.
  • Unknown – The characteristics of the person that are unknown to both self and others.
The original Johari Window (based on Luft, 1969)

An example of a basic Johari Window (my own) can be found here.

Users are advised to reduce the area of ‘blind spot’ and ‘unknown’, while expand the ‘arena’. The premise is that the lesser the hidden personality, the better the person becomes in relating with other people.

The use of Johari Window is popular among business coaches as a cognitive tool to understand intrapersonal and interpersonal relationships. There isn’t much value of this tool as an empirical framework and it hasn’t held up to academic rigor. Still, like many such things it can bring to light the central point that we need to understand our hidden biases.

Another good tool to start understanding biases is a personal audit.

Using the Johari Window for Teams

Teams and organizations have blind spots, think of them as negative input factors or as procedural negatives.

The Johari Window can also be applied to knowledge transparency, and it fits nicely to the concepts of tacit and explicit knowledge bringing to light knowledge-seeking and knowledge-sharing behavior. For example, the ‘arena’ can simply become the ‘unknown’ if there is no demand or offer pertaining to the knowledge to be occupied by the recipient or to be shared by the owner, respectively.

The Johari Window transforms with the the four quadrants changing to:

  • Arena What the organization knows it knows. Contains knowledge available to the team as well as related organizations. Realizing such improvements is usually demanded by network partners and should be priority for implementation.
  • Façade What the organization does know it knows. Knowledge that is only available to parts of the focal organization. Derived improvements are unexpected, but beneficial for the organization and its collaborations.
  • Blind SpotWhat the organization knows it does not know. Knowledge only available to other organizations – internal and external. This area should be investigated with highest priority, to benefit from insights and to maintain effectiveness.
  • Unknown What the organization does not know it does not know, and what the organization believes it knows but does not actually know. Knowledge about opportunities for improvement that is not available to anyone. Its identification leads to the Façade sector.

We are firmly in the land of uncertainty, ignorance and surprise, and we are starting to perform a risk based approach to our organization blind spots. At the heart, knowledge management, problem solving and risk management are all very closely intertwined.

What is this quality profession all about?

A theme of this year for me has been focusing more and more on the difference between the product integrity focused approach to quality that folks in my profession normally focus in on and a more excellence focused approach. The two are not in opposition, but I can’t help feeling that the product integrity exclusiveness of many pharmaceutical quality professionals is holding us back.

This is especially on my mind coming back from ASQ WCQI and thinking about just how few of my pharma colleagues identify with that organization There are a whole host of reasons (including the fact that many people don’t associate with ANY professional association) but I can’t help but contemplate how do we make the excellence side of quality more relevant to not just pharmaceuticals but to wider questions of just what is quality anyway?

I’ve discussed the need to realize that we have different types of domain knowledges, but just what is this domain we call quality and is it truly its own discipline?

Disciplines can be modeled as a system comprising an “activity scope” that is enabled by a “knowledge base” but conditioned by a “guidance framework”.

From Rousseau, et al “A Typology for the Systems Field”
  • The guidance framework typically involves multiple worldviews. The same subject matter can be studied from different worldviews, and the theories around a given subject can be interpreted differently from different worldview perspectives. You can see this in the various flavors of continuous improvement or better yet, the presence of a sustainability push within the society.
  • The knowledge base is the data, theories and methodologies that drive the discipline
  • The activity scope describes the range of activities in a disciple, including the professional practice.

We’re probably truly multi-disciplinarian, in that the we draw from multiple other disciplines, a short list includes: Engineering, Computing, Control Theory, Mathematics, Information Theory, Operations research, system theory, Management sciences, a whole range of social sciences and more than I can think.

What does this mean?

I am more thinking aloud than anything at this point, but I think it’s important to work on developing the QBOK along a guidance framework, knowledge base and activity scope methodology. Then as we develop sub-body of knowledges we drill down from there, either in a very knowledge base way (such as the CMQ/OE) or in an activity scope (like the CPGP). I often feel that the way we develop these are more hit-and-miss and could do with some coherence – the biomedical auditor and hazop auditor are great examples of wanting to meet a very narrow need and thus being very very specific to a small set of the knowledge base.

I guess I’m striving towards applying theory to our practice a little more deliberately.

Some of the technical forums (Human Development and Leadership comes to mind) seem especially designed to pull information from one or two different originating disciplines and adapt it to the knowledge base. I think this process would be added by a coherent understanding of our guidance framework and just what the activity scope we are trying to address as discipline.

In short I am just thinking that a little more coherence, strategy and transparency would aid us as a profession. As I heard in many a conversation last week, we should probably as an organization be better at what we preach.

Sources

  • Bourke, J (2014). On Process Excellence vs. Operational Excellence vs. Business Excellence. BEX Institute.
  • Rousseau, D., Wilby, J., Billingham, J., & Blachfellner, S. (2016). A Typology for the Systems Field. Systema 4(1), 15-47
  • Wageeh, N. A. (2016). The Role of Organizational Agility in Enhancing Organizational Excellence: A Study on Telecommunications Sector in Egypt. International Journal of Business and Management, 11(4), 121

WCQI Day 4

Last day of the conference and for the first session I present on “Knowledge Enables Change.”

Similar to my BOSCON talk, which was the beta so I think I covered things better in this one.

Expand Your Impact on the Culture of Quality by Kathy Lyall

Solid focus on both external and internal signifiers of quality culture. A little basic but very worth reinforcing.

And then I left, skipping the last keynote to get to the airport.

Good conference this year. Overall I felt that many of my choices for sessions ended up being more basic than I thought, but there is a lot of value in that. I will hopefully make the time to turn my thoughts into better blog posts.