6 Tips for Mitigating Manufacturing Risk

When seeking a medical device contract manufacturer, look for evidence of the best practices outlined previously, and consider how the firm has applied risk management into important quality management system audits, including internal audits, complaints, CAPA process, nonconforming product and change management. Select a partner whose program and assessment align well with the manufacturer’s risk management approach.

Tip 3: Reduce the risk of future quality issues by using past performance to evaluate manufacturing capability

Manufacturers of medical devices and combination products often seek and select contract manufacturers based on a given organization’s manufacturing capabilities. During a comparative analysis, several factors can help indicate a firm’s technical fit and manufacturing capability core competency.

Determine if producing a particular product is a core competency for the contract manufacturer. Find out if the firm has a robust equipment calibration, qualification, process validation, preventive maintenance and statistical process control systems in place. Ask if the contract manufacturer is able to perform manual, semi-automated and/or fully automated assembly processes, final acceptance activities, drug handling, final packaging and labeling.

Ensure that the firm’s technical staff possesses the necessary qualifications, training and experience to be successful with the task at hand, and confirm that facility and infrastructure align with the product’s overall contamination control strategy.

More often than not, past performance acts as a strong predictor of future performance. Find out if the contract manufacturer has produced product with similar features and characteristics and a history of successfully producing projected volumes. In conjunction with a comparative analysis, this information will help make an educated decision and reduce the risk of poor quality.

Tip 4: Evaluate the strength and post-market surveillance activities of a potential contract manufacturer’s design control system

Medical device manufacturers must satisfy several design control requirements to remain compliant. Evaluate the answers to the following questions to help reduce risk and determine the strength of a potential contract manufacturer’s design control system:

• Has the firm established, and does it maintain a compliant design control system that could be leveraged to design and develop components, sub-assemblies, medical devices, pharmaceutical primary packaging components, combination product constituents and combination products?

• If a design control system has been established, does the system end with product launch?

• Does the system include post-market surveillance activities designed to provide input to management review to drive continuous improvement as the product and process is “monitored and measured” in accordance with ISO 13485 section 8.2.3 and 8.2.4?

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

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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.