For Medical Device Professionals

Management Review - Measuring the "Heartbeat" of Your Quality Management System
by John Gagliardi, President of MidWest Process Innovation, LLC


May 17, 2010 | Free Downloads | email | Print

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Management Review is sometimes viewed with some ambiguity because there are so many different ways to conduct these planned sessions. Most of the approaches taken by medical device companies to organizing these reviews are (just) compliant and even go so far as to fulfill only the very basic requirements of the Regulations (21 CFR, Part 820) and the standards (e.g. ISO 13485:2003 and ISO 9001:2000).

Being compliant and fulfilling perceived needs are not enough, however. Management Review is commonly driven by the use of various quality tools, depending upon the caliber of deliverables that are expected and the sophistication of your planned metrics. The following article is not a primer for management review but does contain practical approaches to process orientation and communication techniques. This sometimes indescribable information relates to those subtle demands that combine your company’s Quality Management System (QMS) with business goals and objectives. You’ll find that Management Reviews commonly have your company’s unique signature embroidered on the agenda, affecting the approach used to conduct a meeting of this highly visible gathering of process owners and executive management.

This is not a complicated concept. It can be tortuous if handled in an incorrect or highly politicized manner.

Preparation and Logistics

Management review is a requisite requirement for compliance. Management reviewing the suitability and effectiveness of your company’s quality management system is also essential from both a regulatory standpoint and from a position of being accountable for successfully running your business operation.

This is not a complicated concept. It can be tortuous if handled in an incorrect or highly politicized manner. Management Review should be a value-added part of your operation depending upon the value of the inputs and outputs you have planned for and then appropriately realized over time. All too often companies treat this session as "just another long, meaningless meeting" where the Quality Manager conducts a half-day slide demonstration with every kind of color graph and chart, and a lunch is served at break. The quality manager is happy when the ordeal is over because it took three weeks to prepare for the extravaganza and everyone else leaves the meeting feeling rather lethargic and out of sorts with the QMS.

Where’s the return on investment? Efficient and meaningful preparation and an energized approach can "make or break" this review process. Process owners who have a defined responsibility for their process should advocate for the viability and compliance of its content and measure how effectively it is operating in terms of link-related outputs. The Quality Manager doesn't solely own Quality---everyone who participates in the Management Review has a part to play.

Compliance and Business Intelligence

Both the regulations and standards take a rather "broad brush" view of conducting these sessions, although ISO is much more prescriptive. It should be noted that ISO 14969 has many worthwhile suggestions for conducting these reviews. There is little mystery involved with this process of formally embracing certain key metrics and then measuring these marks of success (and failure) periodically to see if goals and objectives are being met.

This periodic review makes good business sense as well. If your company is not connecting "business and quality" then the executive team has truly missed the point. When this review becomes more than just redundant PowerPoint slides and starts dealing with the company’s business strategy, goals and objectives for success, the return on investment is permeated with energy and commitment. Basically, management reviews fail because of the lack of sincere commitment on the part of executive management. Much of the success or failure of this reporting process comes down to top-level commitment and the use of "real" metrics linked to the core competency (s) of your company. It's as simple (and as complicated) as that!

Management Responsibility and Process Ownership

Let's make this even simpler. Management review has been aptly written into the overarching section of both ISO and the cGMPs entitled Management Responsibility. The ultimate responsibility and care for the success (or failure) of your quality system, whether it is viewed from the world of ISO or cGMP-QSR compliance, lies with executive management. It's not just the responsibility of the quality manager or the quality department to enable this process. Top executives at the policy and strategy decision levels of the company should ensure that the quality objectives and related business strategies are in line with the overarching quality policy. Gathering and presenting the information for these reviews is the responsibility of each individual process owner. These owners should present prescribed and purposeful metrics that demonstrate to executive management the success of each process. Compiling these indicators can "paint the big picture" concerning the health of your quality and business systems in terms of suitability, acuity, adequacy and effectiveness.

Basic Inputs and Outputs from Process Owners

ISO is very prescriptive as to the minimal subjects to address during management review sessions. In terms of process ownership and measurement responsibility, they are as follows:

  • The results of Quality Audits (from the Quality Audit Process Owner)
  • Feedback from Customers (from the Regulatory Affairs and Sales Process Owners)
  • Process Performance and Product Conformity (from the Production and Process Control Process Owner)
  • Status of Corrective and Preventive Actions (from the CAPA Process Owner)
  • Follow-up actions from previous review sessions (from the Management Representative)
  • Changes that could affect the Quality Management System (from the Quality Systems Process Owner)
  • Recommendations for Improvement (from Management Review attendees) and
  • Reporting on new and revised regulatory requirements (from the Regulatory Affairs Process Owner)

Minimally, ISO is also prescriptive as to decisions and actions related to outputs from Management Review sessions. These include outputs involved with improvements needed to maintain the effectiveness of the Quality Management System (QMS) and improvements related to product, customer requirements and resource needs.

Frequency (What Does Periodic Mean?)

There is no set frequency for conducting management reviews. The famous answer starts with "at least" (X amount a year) to give you procedural flexibility. Commonly, this is a risk-based decision that is contingent upon the types and classifications of medical devices that your company produces or distributes into the marketplace, the complexity and maturity of your QMS, risk-related issues from previous management reviews, your customer base, and commitment from management to participate.

For instance, an established QMS that supports the processes for Class I medical devices might require only one review per year whereas a Class II or III medical device company could commonly have upwards of four reviews per year. Best practices in this industry tend to lean toward four sessions per year to enable timely responses to trends and critical issues in a formalized fashion. Holding more reviews is acceptable if your QMS is still being built and has yet to mature into an effective and efficient process. Holding one Management Review per year doesn't allow for trends to be captured in a timely manner. The industry "norm" is to conduct reviews at least four times per year to allow for the compilation of trends and to have the ability to realize the successes and failures of deliverables in a timely manner.

Contributors and Deliverables

Process owners representing their functional responsibilities within the QMS should come to the meeting prepared to discuss the measurements recorded since the last review and to compare that data with prior reviews. These metrics should be consistent from review to review to enable the participants to realize trends and draw conclusions concerning corrective and preventive actions, quality improvement initiatives, areas of risk, business strategy, etc. The Management Representative will coordinate these sessions but it is very clear, from a process architectural standpoint, that process owners should bring their results and conclusions for review and decision-making. Outputs from these quantitative results could potentially be addressed by Corrective and/or Preventive Action initiatives and then tracked within the QMS. Simply put, management review deliverables can commonly initiate other actions toward resolving issues and realizing improvement.

Objective Evidence

The top-level objective evidence generated from a management review includes a procedurally-driven process, agenda points, attendance sheets, minutes and—as necessary—ensuing corrective/preventive actions. These sessions are not merely meetings with a beginning and an end (i.e, they are dynamic from review to review to review). The metrics that your company decides upon commonly evolve until you reach the conclusion that these measurements are necessary to show how suitably and effectively your QMS is operating. Every company has different expectations within the range of the necessary points to address (at least with ISO). There is not a magic or silver bullet for success.

One aspect of metrics development and implementation is imperative: once your process owners have chosen viable metrics, don't change them every other review session because it will be impossible to recognize trends if the baselines keep changing. It's not that change is unacceptable but your process owners should be sensitive to trends, risk ramifications and improvements based on consistency. Find measurements that link (with a successful return on investment) to compliance as well as to business indicators and stick with them. This will add consistency to a system–based approach.

Conclusion

Management reviews can be stimulating and an ongoing, rolling phase that keeps the Quality Management System healthy. Your management team can use these reviews to gauge how well the business of quality improvement and compliance is operating and plan for ongoing initiatives to enable process excellence, to produce and market medical devices that are safe and effective and to realize business success and profitability. These sessions don't have to be just another boring meeting but, in fact, can be highly energized, relevant, and indicative of management's commitment to satisfy customer requirements and enable your company to remain in compliance. Producing safe and effective medical devices should be a business goal as well as a compliance deliverable. Smart procedures, relevant metrics, serious process owners who take charge of their responsibilities and measurable outcomes are in your company's future when this process becomes part of your company culture.



John Gagliardi has been successful over the past forty years in the Medical Device and Pharmaceutical industries because of his practical approach to process orientation and business acuity. His career has included active involvement in the areas of research and development, quality assurance, training, operations, process architecture, FDA inspections and regulatory affairs. At Midwest Process Innovation, John specializes in building systems in a compliant and "business-ready" manner.

John is a third-party auditor for ISO 13485, 21 CFR, Parts 820 and 211. He is a US Agent and Official Correspondent to over twenty companies worldwide. MidWest Process Innovation offers training curriculums in design controls, the handling of FDA inspections, purchasing controls, CAPA, CAPA management, Quality auditing, cGMP-QSR and ISO 13485:2003. Reach John at (513) 573-0085 (phone and fax) or email JGAGL777@One.Net.


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