Quality Metrics – Not Dead yet

Pink Sheet has an update this week on the FDA’s Quality Metrics initiative – US FDA Quality Metrics Initiative Continues Moving Forward … Quietly.

This is behind a firewall so may not be viewable by all.

The major takeaways were:

  1. The initiative is still happening
  2. the FDA wants to remind companies why they are doing this in the first place
  3. They are starting a pilot real “soon” now

These metrics have been a hard sell within Pharma. I’ll be curious what steps the FDA will be taking to rebrand the effort.

ASQ – Pharmaceutical GMP Professional Certification

The ASQ’s CPGP certification covers a very broad body of knowledge that covers regulatory agencies, to facilities and utilities, to testing, to release. In short, about every aspect of a GMP facility.

I am maybe the only person I know in the field who has this certification. I don’t know the details, but uptake does not seem as high as other certifications I am aware of. Yesterday at lunch I ended up discussing this with a few colleagues. We discussed a few options:

  1. The certification is not well known. Most of my colleagues were not aware of it.
  2. Many pharmaceutical GMP professionals are more directed at the PDA and ISPE. The ASQ is well known, but perhaps not as important when considering options.
  3. This certification is a generalist. There was a general opinion that many quality professionals tend to be specialized and night not feel comfortable stretching ther wings.

Is there value in this BoK? Definitely. I found this certification much harder than the CMQ/OE, and as a result I’m prouder of having it. The major question is how can we make this more valuable to the field. This is certainly a question I’ll be asking next week in Seattle.

 

Interoperability of Data

Thomas Peither on GMP Logfile in “Industry 4.0 – Inspiration for the Pharmaceutical Industry?” summarizes discussions from the ISPE European Annual Meeting 2018.

There is a lot to unpack in the concept of Industry 4.0. The topic on my mind is data interoperability.

“We identified a struggle with the lack of harmonised and consistent information flows in the industry”, said Volker Roeder

I think this is an understanding that a lot of us, especially from bigger companies that grew from acquisitions and mergers, are grappling with. Decisions made 15+ years ago in the ERP (for example) now has widespread impacts as we start aligning and integrating other systems. It is difficult to align the MES, CMMS, ERP, LIMS and QMS if they all think of master-data differently. Its even harder when one branch of the business deals with master data differently than another branch, but both branches are in the same system.

I don’t have a magic bullet. I just think this is an area that will make Industry 4.0 a great deal more challenging than many of its proponents advocate. And it is becoming a bigger part of my professional life.

Read the article, it is well worth the 10 minutes spent.

Change Management and Communication

All changes need to be communicated to internal and external stakeholders. The development of the communication plan should be part of the change management system.

One of the better models I’ve used is Prosci’s ADKAR.

Picture1

This is a good model because it matches very nicely to the 4 major phases of change.

  • In Propose we focus on Awareness and Desire
  • In Evaluate we focus on Knowledge and Ability
  • in Implement we focus on Ability and Reinforcement
  • And in Close, we focus on sustained Reinforcement and perhaps Awareness of a new change.

Not every change is the same size, and not every change uses the same tactics of communication. Often these tactics are training.

A table, such as the one below, can help.

Item Description of What it is Audience Publication Date
List each of the proposed elements of your communication plan Be sure to include key stakeholder outreach along with all other tactics Who List the date you want the communication delivered

There are lots of good tools out there for communicating. This post was prompted by this post on elevator pitches, which are one of my favorite items in my toolkit. Every change, big or small, should have an elevator pitch ready to go. And make sure it evolves according to the change/process improvement lifecycle.

Thinking in Systems

Thinking in Systems by Donella Meadows is one of the books that has shaped my thinking as a quality professional, and I consider it one of the top 10 books for folks in the quality profession to read. If I ever try to lend you a copy, consider that a good thing.

The basic premise of system thinking is the notion that any force applied to the system has consequences. A well designed system can absorb these forces and still maintain system functionality. A poorly designed system cannot absorb external forces, causing the system to collapse. A key take away of the book is that the systems we design do what they are designed to do, both positive and negative.

Ms. Meadows presents systems and models in ecosystem thinking in ways to avoid simplistic approaches, and explains system oscillations and overshoots as examples of system instability. The book explains the attributes of systems:

  1.   Resilience – ability for a system to adjust. The opposite of resilience – fragility, causes the system to be unresponsive to change, and exposes the system to potential of collapse.
  2.   Self-Organization – ability of system to adjust to new demands and circumstances. Ability of the system to orient itself and build complex structures from simple building blocks is viewed as key characteristic.
  3. Hierarchy – describe how complex system can be broken into smaller, simpler organization that can function autonomously. The opposite of hierarchy is a one complex organism that cannot be productive of parts of it is not performing at the level required for the smooth operation of the system.

The book has a ton of good approaches on how to solve system problems. The identification of leverage point in the system describes how to affect system behavior in most effective way.  The list of leverage point includes quantitative things such as numbers , creating of buffers in the system, as well as introduction of new feedback loops and general system flexibility.

Read this book. Good quality culture understands the systems we build and how they impact the individuals who use them. The tools in this book serve as a good framework, and one I think you will come back to again and again.

 

Communication of Changes between sites

Yesterday, the FDA finalized the ICH Q7 Q&A Guidance on GMPs following its endorsement by the regulatory agencies participating in the ICH in June 2015.

Two-and-a-half-years. And I sometimes wonder why the ICHs aren’t more broadly adopted or why some of my colleagues are a little pessimistic about their impact on this industry

However, re-reading these questions and answers gave me a good topic.

QA on Q7 change management

With complex and virtual supply chains, with world wide distribution, it is important to understand who needs to be communicated about what changes.

This communication should be evaluated for it’s directionality. It helps to break down your types of changes and determine what are:

  • Consult – those changes where the other site needs to provide an assessment. For example, if a change impacts testing that is conducted at another site, or it impacts the way the next site will receive the material (don’t forget ERP changes). These communications are always push.
  • Inform – the other site needs to be aware but will not need to take any action. A great example of this notifying the QP.

Include your suppliers in this process as well, and ensure your suppliers are also appropriately communicating. Include this in your quality/technical agreements or contract terms.