Fit-for-Purpose Initiative

a QMS Agility Model

 

The Chief Quality Officer Forum chartered the Fit-for-Purpose initiative to optimize the Quality Management System for maximum agility and business effectiveness.  This fit-for-purpose approach is based on the risk of your products, strength of your culture and needs of your overall business while remaining compliant with applicable regulations.

How Would You Respond to…

  1. What did you have to do differently as it related to supply, manufacture and release of your products during the Covid shutdown?

  2. How do you think your employees felt about those decisions?

  3. What procedure could you pull out today to proactively guide your employees and operations through another shutdown?

Good News: If the last question leaves you raising your eyebrows, then don’t worry. The QMS Agility Model can fill that gap for you…today!

Getting Started:

The Pathway Fit-for-Purpose Initiative Team Members (listed below) have created a variety of ways to support your successful learning and implementation of this exciting model. Check out these options, and continue reading below to learn more about the impact this model can have in your organization!

  1. Fit-for-Purpose Report: Access the Final Report - Report Access

  2. Fit-for-Purpose Tool: Access the Tool - QMS Agility Tool Access

  3. Webinar Outcome: An Info Session Webinar was hosted to provide an introduction to the work. —> Slide deck access and —> Webinar Recording

Initiative Team Members

Thank you to the following team members who led this great initiative for the benefit of industry and the patients/customers we all serve!

  • Ingrid Cabalza, illumina

  • Mark Frankenberg, P&G

  • Alan Johnson, AstraZeneca

  • Shirley Murphy, Takeda

  • David Murray, illumina

  • Marla Phillips, Pathway (former Merck)

  • Melissa Smith, P&G

  • Eva Urban, CSL Behring

Benefits

The Fit-for-Purpose Model can proactively guide right-sized decisions, reduce exposure to risk, and increase employee trust in the leadership of your organization, such that it:

  1. Enables your organization to move from a standardized approach that is often over-engineered for various products and situations.

  2. Provides transparency to employees as to when, how and why QMS variations are used, which is linked to predefined, consistent processes.

  3. Assesses QMS adjustments needed to appropriately factor-in Time and Cost Pressures, for product, patient and business success.

  4. Includes cross-functional alignment on the decisions involved.

Overview

Check out the report to read all the details on how to incorporate agility into your operations, including how to pivot your actions with strategies to navigate time pressure, cost containment requirements and longterm ROI drivers!

The Fit-for-Purpose Model has 4 important steps to guide you to successful outcomes:

  • Step 1 - Project Drivers: Identify project drivers, such as time pressures, cost containment pressures, and long-term ROI pressures.

  • Step 2 - Project Context: Develop the Project Context, including the project drivers identified in Step 1, as well as voice of the customer, understanding intended use and risk, etc.

  • Step 3 - Broad Strategies: Compare side-by-side strategies that clearly show how to operate differently depending on your project context. “Normal State” is provided as a comparison for both regulated and non-regulated products.

  • Step 4 - Fit for Purpose Actions: Having a strategy without actions is not enough! Compare the different actions needed across the total product lifecycle and for system deployment. Optimize your actions for patient and business success

Implement Today!

The report, tool, webinar and workshop are all designed to support your implementation process. Wondering how to put this model into action? Company Champions who are leading the implementation of this work have suggested the following ways to incorporate the Fit-for-Purpose Model within your existing Quality Management Systems:

  1. Engrain the Fit-for-Purpose Model in your existing Risk Management process

  2. Ensure the Fit-for-Purpose Model is part of your project chartering activities


Questions? Contact Marla Phillips (Initiative Leader)