If your company’s Management Review sessions are a waste of time, that’s your fault.
Change your approach!
Change the format!
Change the players!
Make it real!
Management Review, a regulatory requirement, can be a value-added experience with thoughtful accountability, expected responsibility and successful compliance. Look at them as business tools without the dollars.
Take ownership and make them impactful. Avoid presenting dreary bar and pie charts that send the same message over and over again. This is not complicated, but it can be tortuous if handled in an incorrect or in a highly politicized manner. Keep the politics in the board room and remember that Management Review is actually a good thing. Here’s why.
Accountability is Key
When it comes to the global manufacturing of medical devices, conducting Management Reviews on a consistent and periodic basis is a requirement of 21 CFR, Part 820 and ISO 13485:2016, respectively. Part of total quality management requires companies and individuals to measure performance, compliance and, although not a direct requirement, business acuity.
Yes, you and your company are accountable and this accountability is an edict for doing business in the medical device industry.
I have observed many companies that treat Management Reviews like a necessary evil, or a bitter pill to take. Many companies hold Management Review sessions four times a year, but some only have formal reviews twice (or maybe even once) a year. (See the sidebar below for thoughts on frequency.)
Comments Heard in the Hallway
Here are some of the typical comments I hear from process owners and top-level management alike:
“I don’t have time to spend reviewing measurements and metrics that we don’t take action on anyway.”
“FDA can’t look at the minutes anyway.”
“This is the Quality Manager’s meeting…..he puts it together, writes the agenda, records the minutes and shows the same measurements using five different graphing formats. What a bore.”
“Don’t bother me with this quality stuff; we need to make the numbers for this month.”
Management Review is not a Quality Manager’s meeting. If it is teed up that way at your company, no wonder it seems boring and ineffectual. Nothing against the quality managers of the world, but if the rest of management are not hands-on involved, Management Reviews can turn into snooze sessions.
Efficient and meaningful preparation and an energized approach can make or break Management Review. 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 or Management Review—everyone who participates in the Management Review has a part to play.
Gathering and presenting the information for these reviews is the responsibility of each individual process owner. These owners should present both prescribed and purposeful metrics that demonstrate to executive management the success of each process. Compiling these indicators can paint a bigger picture about the health of your quality and business systems in terms of suitability, acuity, adequacy and effectiveness.
Process Owners and Contributors Make it Genuine
Process owners representing their functional responsibilities within the Quality Management System (QMS) should come to Management Reviews prepared to discuss measurements and ensuing metrics to compare that data with prior reviews. We’re looking for improvement or lack thereof. These metrics should be consistent from review to review to help participants realize trends and draw conclusions concerning corrective and preventive actions, quality improvement initiatives, areas of risk, business strategy, glitches, etc. The Management Representative will coordinate these sessions, but it is (and always has been) very clear, from a process architecture standpoint, that 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. When you think about it, Management Reviews are a very simple, straight-forward concept. At times, politically-charged reviews become turf battles and combat zones for blame. Strive to avoid those situations.
There is no right or wrong number. The notorious answer starts with “at least” (X amount a year) to give you procedural flexibility and the right to cancel at the last minute. Commonly, this is a risk-based decision that is dependent 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 empowered customer base, and commitment from management to (really) participate.
For instance, an established QMS that supports the processes for Class I medical devices might require only one Management Review per year. A Class II or III medical device company could commonly have upwards of four 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.
- John Gagliardi
Choose an Approach and Then Improve It
Management Reviews are sometimes viewed with some ambiguity because there are many different ways to conduct them. Most of the approaches taken by medical device companies are just compliant, and even go so far as to fulfill only the very basic requirements of the regulations and standards.
Being compliant and fulfilling perceived needs are sometimes not enough, however. Management Review is commonly driven by the use of various quality tools, depending upon the level of deliverables that are expected and the sophistication of your planned, legacy-based metrics.
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 a top-shelf management representative. Just because it’s yours and company-unique doesn’t mean it’s effective or value-added.
The method of carrying out the review should suit your organization’s business practices and could include:
- Formal face-to-face meetings with an agenda, minutes and formally-identified action points
- A variant of the above by teleconference or internet links, when logistically necessary
- Partial reviews at various levels within your organization and a report to the top management that reviews the reports
Some Requirements are Prescriptive
To name a few of these requirements, your company must establish procedures for Management Review sessions that include:
- Adherence to mandatory inputs and outputs (at least in the case of ISO)
- Identification of who and how many process owners must attend
- Frequency and scope of these reviews based upon risk
- Presentation of measurements vs. strategically-challenging metrics for success and compliance
- Realization of trends toward improvement and part of fulfilling the company quality plan
This is not just a hallway conversation or a weekly staff meeting. These Management Review sessions should be documented, followed-up and should measure the effectiveness of your QMS in relationship to your business model. This is the closest your company will get to actually looking at the regulations and standards in terms of how the effectiveness of the QMS can (and should) have an effect on the strategic business goals, the bottom-line and the success of the business (ad)venture of the employees, whether or not they think in terms of the company’s best interests.
Management Review sessions can tell employees how effectively and efficiently they are working in terms of non-conforming product reports, training and competence indicators, complaints from valued customers and patients, corrective action effectiveness, process ownership in terms of compliance, etc. If you’re not sure what preventive action is or where you find it, attend a well-orchestrated Management Review session.
Management Review meetings should be designed to ensure that at least all required quality related functions are reviewed by top company executives, and that all levels of management affecting quality are made aware of changes, updates, revisions, verification activities and policies. The Management Review should take the form of a formal, recorded meeting.
Both the regulations and standards take a rather broad view of conducting these sessions. 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 quality goals and objectives are being met.
Individual Problems and Problem Solving
Individual problems should be dealt with as they occur, without waiting for the next Management Review. If you’re problem solving the latest rejected batch or lot number during a Management Review, you are wasting your time and aren’t compliant with the intent of this session. Management Reviews are intended to see if the same problems re-occur (establish trends), if the actions taken are appropriate and addressing a systemic approach, and if the customer and regulatory requirements are aligned with strategic business goals and objectives.
Attention given to individual problems should only be complemented by a review of the entirety of the QMS, in order to see if it is effective in meeting your organization’s systemic requirements. Management Review should not be devoted to repeatedly discussing relatively insignificant problems. Rather, it is more useful if it carefully considers reported trends to obtain a clear overview and does not just review a list of small, tactical details. Top management should analyze and decide on significant quality system tendencies for business and compliance reasons.
Management Reviews can be stimulating and eye-opening. These sessions don't have to be more ineffectual meetings. In fact, they can be highly energized, relevant and indicative of management’s commitment to satisfy customer requirements and enable your company to remain in compliance. This tool is also a complement to any business model and can be instrumental toward strategic business decisions.
Producing safe and effective medical devices should be a business goal as well as a compliance deliverable. Smart and timely procedures, pertinent, well-thought-out measurements and metrics and serious process owners who take charge of their responsibilities and measurable outcomes can be part of your company’s future when this process becomes part of your company’s culture.
If you dread Management Review sessions, think again. No one says that they have to be dull and lacking in ROI. It has always been your choice, since ISO and the cGMP-QSR became popular in the mid-1990s. I know that it is not as exciting as putting out fires and riding in on your white horse to save the day. But step back and see the big picture.
When they become more than just redundant PowerPoint slides and start dealing with the company’s business strategy, goals and objectives for success, the ROI on Management Reviews is permeated with energy and commitment.
Management Reviews fail because of the lack of sincere commitment on the part of management. Much of the success or failure of this process comes down to top-level commitment and the use of metrics linked to the core competency of your company. It’s as simple (and as complicated) as that!
John Gagliardi has had success over the past 45+ years in the medical device and pharmaceutical industries because of his practical approach to process-orientation and business. He has been actively involved in research and development, quality assurance, training, operations, process architecture, FDA inspections and regulatory affairs. Mr. Gagliardi specializes in building systems in a compliant and business-ready manner. Mr. Gagliardi can be reached by email.
MidWest Process Innovation, LLC