Putting the ‘Management’ into Quality Management System
Over the past decade, FDA Quality Management System (QMS) deficiency findings in the form of warning letters consistently rank corrective and preventive actions (CAPA) (CFR 820.100), complaint files (CFR 820.198), and design controls or process controls (CFR 820.30 and 820.70 respectively) as the top areas that companies struggle with. Hidden within these statistics is a lesser known but just as critical QMS requirement: management responsibility.
Management responsibilities are described in 21 CFR 820.20 and consist primarily of the following:
Establishing quality policies, practices and processes.
Managing, qualifying and organizing resources.
Reviewing the effectiveness and suitability of the QMS.
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Within many warning letters attributed to the “heavy hitters” described in the opening are deficiencies related to management not having sufficient oversight over other quality processes. For example, within many CAPA findings you may stumble upon a finding related to CFR 820.20 where “management was not made aware of a critical issue” or that a “CAPA plan lacked sufficient management oversight.” In the example below, a warning letter describes that deficiencies related to poor management and reporting of complaints per 820.198 are also likely due to lack of management involvement:
[…] your firm's lack of compliance with 21 CFR 820.198(d) may involve more than just inadequate procedures and lack of employee training, and may involve ineffective management oversight. Your response does not state the period of time that the QA/QR Manager will continue to review complaints with appropriate personnel. Effective management oversight should be ongoing.
This example is a great illustration of how FDA inspectors do not review management responsibility requirements in a vacuum; rather, they apply the requirements to all quality management system elements to ensure that management is deeply entrenched in decision making within the company.
Here are five tips to demonstrating management commitment within your quality management system:
Management review frequency and scope should be commensurate with your company’s scope and size, product complexity, and product risks and “quality health.”
CFR 820.20(c) mandates that “management with executive responsibility” reviews the suitability and effectiveness of the quality system at a defined frequency. First of all, what exactly does “suitability and effectiveness” mean? The answer lies in your quality policy and quality objectives, also defined within the management responsibility section of the QSR.
For instance, within a contract manufacturing organization, a quality policy and supporting objectives may relate to customer satisfaction. These objectives may be defined within key performance indicators (KPIs) or other metrics, such as complaint percentage, customer satisfaction feedback, and/or audit results. Ensure that what you’re reviewing directly traces back to the quality policy and quality objectives. For example, if a quality objective is to have a field complaint rate less than 1%, your review of CFR 820.198 (complaints) and CFR 820.100 (CAPA) system’s suitability will depend on how well they have helped achieve the objective.
When it comes to determining frequency and scope of the management reviews, consider the following:
Size of your company. Larger companies generally require more robust quality management systems, which is no exception for management review requirements. As a rule, larger companies should have more frequent or larger scope management reviews.
Product complexity and risk. Manufacturers of Class III products are usually expected to hold a more comprehensive management review or hold multiple reviews on a yearly basis. The higher the risk of a product, the more frequently the review of the processes that develop and manufacture said product. Furthermore, if a company is known for manufacturing very complex medical devices, it may be useful to review QMS suitability more frequently to ensure that the complexity of the product’s development, manufacturing and post-production processes are adequate.
Quality “health.” If your company is under an FDA action or warning letter, or internal findings from previous audits or management reviews have yielded poor results, management review frequency may be adjusted to more closely monitory the QMS.
Practically speaking, I usually advise clients to hold management reviews yearly only if they are manufacturers of low-complexity, low-risk devices and have a stellar track record of quality. Otherwise, quarterly management reviews or semiannual design reviews are preferable.
Design reviews should preferably be reviewed by multiple management representatives.
Review of design progress per 21 CFR 820.30(e) already requires an unbiased, “independent” reviewer. Just as important, however, is having relevant functional managers participate within design reviews. Functional managers within a design inputs review early in the development process may be limited to project management and engineering, for example, versus bringing in the manufacturing management team prior to and during a design transfer review, as an example.
I often see clients hold multiple reviews with zero management involvement until the product is ready for design transfer. This inadequate practice leads to stakeholders being left in the dark until its too late—or too expensive—to make a design change. Having a manager merely as an approver on a design review may not be sufficient if the representative did not participate within the review.
The CAPA process is both an input and an output of a successful management review—and management should be heavily involved at both ends.
Management review determines the “health” of your quality management system. Properly diagnosing QMS effectiveness and suitability involves reviewing several inputs, including (but not limited to) the following:
Previous management review findings.
Audit results (internal/external and supplier).
QMS requirement updates (regulations, standards, etc.).
Postproduction information (customer feedback, complaints).CAPAs.
Interestingly enough, management reviews may also determine that a systemic or high criticality issue exists within the QMS that needs to be addressed, which also may become a CAPA. Just a word of caution here: management review content is exempt from FDA review (refer to CFR 820.180(c)), but if results are used as a basis for opening a CAPA, that will be discoverable by the agency.
Management may be involved in CAPA systems at multiple points of the process including (but not limited to):
During containment and/or disposition activities, a management representative may be involved to help determine the impact of an issue and whether product must be contained or, if the severity is high enough, recalled from the field. A regulatory manager or quality manager helping make or at least approve containment and disposition activities is a welcomed site to an FDA investigator.
During investigation, managers may be called upon to review investigation results including determination of the root cause. Management oversight of root cause investigation activities shows solidarity with investigators and commitment to building and enhancing quality practices.
During the corrective and preventive action planning, managers should review the plans and ensure that proper quality techniques and practices are being used.
During CAPA metrics review, managers should be informed of open CAPAs, CAPA closure rates and other CAPA KPIs. Many companies host “CAPA Dashboards” or “CAPA Reviews” on a weekly or monthly basis that reviews this information with management, a sure way to involve managers in escalating and resolving issues as they arise.
Management responsibility is a critical underlying element to the entire quality management system that often gets overlooked. Ensuring that management is integrated within key QMS processes like CAPA, design controls, and postproduction monitoring helps ensure that critical deficiencies are caught and addressed early and often.