Today we would like to introduce you to a process that one of our Quality System SME, Eng. Roberto Correa with his LEC team, designed and validated to perform a Quality Capability within any Life Sciences company in a very short time frame.

Utilizing the D-M-A-I-C Model as a foundation, the objective is to update the Organizational Capabilities for [Site] Quality Assurance and assess their current state to deliver against the local and global long-range strategy and plan, with that they will be able to take the appropriate actions to ensure they can deliver the expected results.

The key steps of the process are as follows:

  1. Interview with Quality and Operations leader from the site
  2. Plan the process (define agenda and participants)
  3. Perform two workshops with key QA staff and Key QA stakeholders
  4. Perform QA staff assessment
  5. Compile the data
  6. Develop an action plan
  7. Approve the plan and confirm resources availability
  8. Execute the plan
  9. Monitor results

From the service perspective, this exercise takes approximately 40hrs. of work per site evaluated and it provides so much light for pro-active remediation program, avoid negative audit findings and help you to save money and time.  If you would like to receive a quote for conducting such a great assessment in your company please contact us at Lean Enterprise Consulting.