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By Leigh Toole
Tip 5: Assess the root cause analysis tools used to determine how organizations respond to problems and drive continued improvement
The true measure of control associated with sustainable manufacturing is long-term supply “on time in full” and “right the first time” without disruption. Knowing how the contract manufacturer will respond when problems arise is crucial to sustaining an effective manufacturing operation.
Problems offer an opportunity to reveal a contract manufacturer’s ability to demonstrate specific root cause analysis tools. Under the Tech Group’s risk assessment system, an investigation can be performed at any time, though Level 1 (low occurrence, low risk) issues do not require investigation. Level 2 issues require a documented justification if an investigation is not performed. If not escalated into the CAPA system, Level 3 (high occurrence, high risk) issues require investigation and a documented justification.
Contract manufacturers should know how to respond when problems arise, and an effective firm will deploy resources based on risk from a quick evaluation that defines the frequency and severity of a given event. When evaluating a potential contract manufacturer, review the critical quality systems to determine strengths or weaknesses associated with the firm’s ability to recognize problems, determine root causes, effectively contain the issues, apply corrections and implement corrective and preventive actions that drive significant continuous improvement.
Tip 6: Measure the partnership’s success with a robust quality agreement
A robust quality agreement should identify specific roles and responsibilities of each organization, as well as guidance and rules of engagement associated with the critical quality systems. It should be implemented prior to forming a partnership or in the early stages of development.
The quality agreement must define formal governance expectations for the working team, management team and management with executive responsibility. These meetings will help drive continuous improvements and accountability to a predetermined and agreed upon scorecard that measures the success of the partnership.
These factors, along with comparative analysis and site audits, will greatly affect the contract manufacturer selection process by uncovering issues prior to entering a contractual partnership. It is important to know specifically what constitutes a great fit in a strategic contract manufacturing partnership. Contract manufacturers are not “one size fits all,” and device manufacturers must invest time and dedication in the selection process. By doing so, the reward is an exponential return on the initial investment that will lead to the long-term successes associated with a successful and effective partnership.
Published in the February 2013 issue of Pharmaceutical Manufacturing magazine
ABOUT THE AUTHOR
Leigh Toole is Director of Quality at The Tech Group, a subsidiary of West Pharmaceutical Services Inc. To learn more about contract manufacturing quality and other issues, read West’s blog at http://westpharma.wordpress.com.
PharmaManufacturing.com is the site for knowledge, news and analysis for manufacturing and other professionals working in the pharmaceutical, biopharmaceutical and biotech industries.