Month: April 2018

Change Management and Change Control

Change Is

Change Management and Change Control is a topic that I cannot discuss enough. Which is a good thing because I am presenting on it at the 2018 ASQ World Conference.

Below is the proposal I submitted.

Session Type: Workshop

Title: Change Mgmt & Control-Lessons from Consent Decree

Presentation Description:

Drawing on the experiences of a company under a FDA consent decree, this workshop will consider change management and change control, and how they are improved upon by a grounding in knowledge management and risk management. The lessons learned and applied are relevant not only to the pharmaceutical industry, but to other FDA industries (medical devices, cosmetics, food, etc.), and to other heavily regulated industries (energy, mining, financial services and beyond). It is easy for a company in these situations to focus on change control and forget the wider scope of change management. During this workshop we will share improvements made in our processes as a result of being under the consent decree, as well as several templates, and tools to enable good change management, and change control activities.

Presentation Summary:

The Pharmaceutical Quality System described by the International Conference of Harmonization (ICH) is a holistic approach which facilitates the consistent development and production of high quality pharmaceutical products. It aims to support innovation and continual improvement of products, processes, and methodologies using knowledge management and quality risk management. Providing a lifecycle approach to pharmaceuticals, change management is a key element to this approach.

The Pharmaceutical Industry is one of the most regulated industries. In the US, the Food and Drug Administration (FDA) often uses the consent decree as the ultimate enforcement tool for those who break the rules. A company under consent decree needs to prove, via third party, that it has achieved and can sustain regulatory compliance. Companies under a consent decree must break down and build up their entire quality system.

After this workshop attendees will be able to:

  • Evaluate lessons learned from a consent decree and building a robust pharmaceutical quality system for your use.
  • Explain how the pharmaceutical experience can deepen your understanding of ISO 9001:2015, especially risk based thinking
  • Identify how change management fits into a culture of quality
  • Understand how the change management system increases compliance
  • Use a few simple but effective tools for change management.

The ICH quality approach developed from ISO 9001:2008 but in many ways preceded the risk based thinking pivotal to IS 9001:2015. Utilizing a matrix of similarities and differences between traditional GMPs, the ICHs and ISO 9001:2015, we will explore several lessons learned from consent decree activities, and demonstrate principles of change management.

This workshop will explore change management from the three lenses of science, regulation and risk, with a focus on knowledge management and risk management as enablers of successful change management. Several examples will be shared to demonstrate the fundamental connections between these systems.

The basis of this workshop will be change management as a fundamental part of a culture of quality. We will share best practices based on lessons learned from the consent decree around the impact of cumulative changes and large-scale versus incremental change.

Compliance for change management necessitates clear accountabilities, prioritization of changes, and the role of the quality unit – including the importance of a change champion or steward. This workshop will explore the relationship between change control, which often refers to the execution step of an individual change, and change management, which is a more systematic, holistic approach to the review and management of a portfolio of changes and the change process.

Managing change on the personnel and organization will be evaluated, especially as it interfaces with knowledge management. Several tools will be shared for determining and mitigating risk and impact, including a training matrix.

By the end of the workshop we will have shared several tools, including a matrix to evaluate cumulative changes, a risk-based change evaluation tool, and a scope setting method that incorporates an evaluation of knowledge and risk.

Focus Area: Risk and Change

Presentation level: Intermediate

Industry Area: Food/Drug/Cosmetic, but all manufacturing can benefit

Presentation Best Matches this Technical Area: Quality Management Principles

Who should attend: Senior/Executive Officer, Director, Manager, Supervisor, and all others involved in change management

Presenter information: Jeremiah Genest, CMQ/OE, CPGP. Sanofi – Genzyme, Quality Systems Manager

Biography: Jeremiah Genest has 20 years quality systems experience in the energy and pharmaceutical industry, with over a decade’s experience implementing and running quality systems in the biotech field. For the last four years, he has managed change management at Sanofi’s Allston Landing Facility, which is under an FDA Consent Decree. He is a Certified Manager of Quality/Operation Excellence and Pharmaceutical GMP Professional.

 

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Quality Book Shelf – Kafka

In a past job interview I was asked two questions that stay with me, “What degree do you think every quality professional should have” and “Which of your favorite authors reflects on you as a quality manager.”

For the first, I said philosophy, a rather tongue in cheek answer that I hope will become clear as this blog develops.

For the second, I answered LeCarre and Kafka. I’d like to expand on Kafka, as it has to do a lot with the name of this blog.

Kafka is, probably, one of the 20th century’s greatest writers on organizational life. His writing is often a dystopian counter to much of the cheerleaders, even today, of the mythology of organizations. In this way he serves as a needed balance to all the cheerleaders of holarchy, of agile and lean organizations and everything else that dominates modern business since Weber. Through exploring these dark contemplations I strongly believe we grow in our understanding and that understanding can make us more humble.

Kafka deals with issues that lie at the heart of the challenges that await the modern organization, and of quality as a profession: rationality, bureaucracy, power, and how we make sense of the work and the value of the work we do.

As this blog is going to be about applying rationality to the work we do, grappling with bureaucracy and power, and how quality practices bring sense to the work we do, Kafka is an appropriate inspiration.

The Journey Begins

Thanks for joining me!

Start with what is right rather than what is acceptable. — Franz Kafka

Let me introduce myself. I am a quality manager in the pharmaceutical industry who for the last year has been doing quality systems deployment, and previous to that spent 4 years running the change management/change control program at a site under a consent decree with the FDA. I’ve spent almost two decades developing, implementing, and maintaining quality systems in biopharma. I an a senior member of the American Society of Quality with my Certified Manager of Quality/Operational Excellence (CMQ/OE) and Pharmaceutical GMP Professional certifications. I’ve been known to haunt one or three other professional associations.

This blog is my attempt to explore what I’ve learned. It is a example of thinking out loud. Perhaps, in that, it will be valuable to others.

The views and opinions expressed in this blog are those of the individual blogger (Jeremiah Genest) and should not be attributed to any company with which the blogger is now or has been employed or affiliated.