6 Tips for Mitigating Manufacturing Risk

Medical device manufacturers partner with contract manufacturers to identify potential risks and help produce safe, reliable, high-quality products

By Leigh Toole

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Amidst increased customer expectations and heightened regulatory requirements, medical device manufacturers must be able to meet the demands of an increasingly competitive marketplace. Many medical device manufacturers partner with contract manufacturers and suppliers to help produce safe, reliable and high-quality products.

Selecting the right partner can help ensure the success of a drug product, and medical device manufacturers should perform a comparative analysis of the options available. Start by performing an audit of the potential contract manufacturer’s quality management processes. To begin, request a copy of the organization’s quality manual. Compare quality manuals from three to six firms; pinpoint differences and determine how each potential partner’s approach aligns with the manufacturer’s own quality processes. Such an analysis can be completed quickly with minimal expense, and will narrow the list considerably.

Prior to entering into a partnership, conduct a site audit to further compare the contract manufacturer’s ability to meet specific needs. Site audits can help medical device manufacturers review each supplier’s ability to meet specific needs and establish the firm as an approved, certified and qualified supplier.

In conjunction with a site audit and a thorough comparative analysis, medical device manufacturers should evaluate a firm’s quality management system, risk management tolerance, technical fit/manufacturing core competency, design control capability and root cause analysis tools. These factors can help medical device manufacturers identify potential risks associated with outsourced manufacturing and support an informed partnership decision.

Tip 1: Measure the strength of a quality management system against regulatory standards
and verify company-wide implementation

In order to ensure product safety and efficacy, medical device manufacturers must comply with quality system regulations as defined by the standards set by the countries in which their products are sold. In the United States, medical device manufacturers and partners must develop a quality management system that meets the standards outlined in the FDA Code of Federal Regulations Title 21 Part 820 Quality System Regulation (QSR). In Europe and several other countries, medical device manufacturers must ensure compliance with requirements outlined in the International Organization for Standardization (ISO) 13485.

A comparative analysis can determine how suppliers plan to meet predetermined FDA QSR and ISO requirements. Many firms do not define key processes needed for the quality management system, as well as the sequence, interaction and associated control strategy. Failure to meet this requirement can have implications on the quality culture of the organization and effectiveness of the management team.

During evaluation, review how the contract manufacturer has elected to meet the ISO 13485 requirement in section 4.1 (a) to “identify the processes needed for the quality management system and their application throughout the organization” and in section 4.1 (b) to “determine the sequence and interaction of these processes.” Comparative analysis will determine whether the firm has failed to meet this requirement or invested the time to define these processes.

It is important to confirm that all employees have been trained and understand the firm’s quality policies and objectives. Review the content of the contract manufacturer’s quality policy and quality objectives with the management team. Request the team provide documented and objective evidence that verifies the quality policy and objectives have been implemented and are well understood across the organization. The strength of an organization’s quality management system can be an early indicator of things to come. A new partnership between a medical device manufacturer and a firm whose approach aligns with its own quality management system will be much stronger than one that does not.

Tip 2: Select a partner whose risk management program aligns with the manufacturer’s approach

Contract manufacturers must establish rules for when to use a particular risk management tool. The requirement in ISO 13485 section 7.1 (d) notes, “the organization shall establish documented requirements for risk management throughout product realization.” This section also indicates “… ISO 14971 [for] guidance related to risk management.”

Risk management shortcomings may require greater oversight, and more rigorous review and approval of issues. As such, it is important to determine the potential firm’s comfort level of residual risk and strength of an organization’s risk management rules. Questions to ask include:

  • When should a preliminary hazard analysis be performed?
  • When should a design Failure Mode and Effects Analysis be generated?
  • What are the rules of engagement for risk priority numbers in terms of when risk mitigation activity is appropriate?
  • Does the firm provide a documented evaluation (based on frequency and severity) that establishes a defendable rationale regarding when issues will be investigated and/or escalated to the corrective and preventive action (CAPA) system?
  • Is risk management applied throughout the entire product lifecycle?

One contract manufacturer may be more risk tolerant than another. If the potential firm’s comfort level of residual risk varies greatly, it will be more accepting and comfortable of higher risk priority number outcomes than the device company’s system allows without the need for mitigation, reduction or the elimination of the source(s) of the 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.

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