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Medical Device Management Review Procedure Improvements

management review Medical Device Management Review Procedure ImprovementsThe author provides suggestions for improving the writing of your medical device management review, scheduling meetings, and engaging top management. 

If the US FDA is not allowed to see Management Review meeting minutes, why were there one-hundred and seven 483 inspection observations against the Management Review process in FY 2012?

The US FDA is also not allowed to view records for internal audits and supplier audits, but there are 483 observations for these processes too. The FDA will assess the effectiveness of these processes by reviewing your procedures by verifying that you have a schedule, and you’re sticking to it. The ultimate test is to look for CAPAs initiated from these processes.

To avoid a 483 inspection observation against your Management Review process, you need four things:

  1. Procedure for Management Reviews
  2. Schedule for your Management Reviews
  3. Template to prevent errors
  4. The top management team that is trained

Writing a Medical Device Management Review Procedure

There is no requirement for a Management Review procedure in ISO 13485, but 21 CFR 820.20c states that the quality system shall be reviewed “at defined intervals and with sufficient frequency according to established procedure.” This frequency may be documented in the Quality Manual, or a Management Review procedure.

If you choose to write a procedure, keep it simple and reference a controlled template that includes each of the requirements listed above. Your procedure should also allow flexibility for each of the following probable events:

  1. Management Review requires rescheduling
  2. Some of the Management Team is unable to attend
  3. Some of the Management Team can only attend by conference call
  4. An action item from a previous review is left incomplete
  5. An action item is changed after the Management Review
  6. There is insufficient time available to review all the inputs during a single Review

Your Schedule for a Medical Device Management Review

The most common procedural requirements for the frequency of Management Reviews are:

  1. At least once per year
  2. Semi-annually
  3. Quarterly

Most companies choose to require a schedule of “at least once per year,” but what’s the point of reviewing quality system data from last February in January?

13485 Plus is a guidance document for the implementation of ISO 13485. Section 5.6.1 of the guidance document states, “If changes are planned or being implemented, more frequent reviews are normally needed.” Some companies even include this statement in their Management Review procedure. Unfortunately, most companies do not remember to change their schedule when they plan significant changes to their quality management system—such as mergers, new product launches, or an employee lay-off.

Every Management Review should include an action item scheduling the next Management Review. The timing of the next Management Review should reflect changes planned for the quality system and improvements needed to maintain effectiveness.

Conducting more than one Management Review also gives you the flexibility, assuming your procedure allows it, to review only some of the required inputs during a single Management Review. If you are short of time during your next management review, you could intentionally skip a required element. However, this approach also requires that you track which elements have been covered during your annual schedule and which elements were not. Any skipped elements must be covered at least once during the annual schedule for Management Reviews.

A Template for Medical Device Management Review

One of the most common nonconformities during an ISO audit is a finding that one of the required inputs or outputs was not included in the Management Review. The best way to ensure you don’t forget something is to use a template that is maintained by your document control process. This template should include the following:

  1. Eight Inputs (ISO 13485, Clause 5.6.2)
  2. Three Outputs (ISO 13485, Clause 5.6.3)
  3. Review of the Quality Policy (ISO 13485, Clause 5.3)
  4. Review of the Quality Objectives (ISO 13485, Clause 5.4.1)
  5. Review of the QMS effectiveness (ISO 13485, Clause 5.6.1)

The last item should be a conclusion in your management review meeting minutes. Often, the conclusions are worded in the following way, “The Quality Management System remains suitable, adequate and effective—with the exception of the areas that have been identified as requiring corrective actions in this management review.”

Engaging Top Management

Roles and responsibilities for the Management Review must be assigned. Some leaders choose to assign 100% of the Management Review to the Management Representative, and then the same executives complain that reviews are boring and take too long. To get the management team engaged, the responsibility for preparing reviews must be assigned to all members of the team. The Management Representative is responsible for “reporting to top management on the performance of the quality management system and any need for improvement.” Still, the ISO Standard does not imply that the representative cannot seek help from the rest of the team.

Each member of top management should be assigned responsibility for preparing and reporting on the part of the Management Review. This approach will ensure that all members of the management team are involved and engaged in the process. Your team may be assigned to work in pairs or smaller teams. Your team’s responsibilities may also be rotated to ensure that each member of the team is cross-trained and understands the importance of each Management Review requirement.

Before you can expect your management team to accept responsibility for preparing and reporting on the performance of the quality management system and improvement needs, Top Management needs the training to understand each of the requirements.

Free Webinar Training

Medical Device Academy also offers free webinar training on the Management Review process. If you are interested in training your top management team, please register for this management review webinar. It will also be available as a free recording for anyone that is registered. Registrants will also receive a copy of the webinar slide deck and a copy of the Medical Device Academy’s Management Review template.

 

Posted in: ISO Certification

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Management Representative Requirement: ISO 9001:2008

The author reviews the Management Representative section 5.5.2 of ISO 9001:2008 requirement and provides eight (8)  proposed actions to take for companies who receive a finding against this section.

The idea for this posting was from a thread I found on Elsmar Cove: http://elsmar.com/Forums/showthread.php?t=45658

One person posted a question about the requirement for the Management Representative (MR) to be a member of the organization’s management (see section 5.5.2 of ISO 9001:2008). Companies that are seeking initial certification sometimes struggle with this requirement. Some struggle because they do not have anyone in-house that is sufficiently trained to be the MR. Other companies struggle because they are very small and outsource their QA functions to a consultant. The following blog is targeted at helping these companies.

Auditing

I audit companies to the ISO 13485 (medical Quality Management System (QMS) & 9001 (QMS) Standards. The intent of both Standards was always to have the MR be part of management, but some companies did not interpret the Standards in this way. With the 2008 revision of 9001, the possibility of misinterpreting the meaning is much less likely. Companies that receive findings during the Stage 1 or Stage 2 audit for this requirement usually fall into one of two categories. Category #1: our company is small, and the only person that knows enough about ISO requirements is not a member of management. Category #2: our company is small, and we outsource QA functions.

The good news is that any manager can be assigned the responsibility of being MR. One of my clients assigned this responsibility to the VP of Sales. Another company appointed this responsibility to the Director of R&D. Both of these individuals had to put in the time to learn about their quality management systems, but both have embraced the challenge, and I have learned much from them. They have a different perspective and bring a lot of value to the MR role. The bad news is: whomever you assign has to learn enough to be competent in the position.

The definition of “Management” is typically a stumbling block. Most people think of managers requiring that they have other people reporting to them. This is not absolute. The MR should report directly to a top manager, such as the President or CEO, to prevent conflicts of interest. As a manager, they should not require a great deal of direct supervision, and the President or CEO should not be overly burdened by adding one person to their list of direct reports. Some auditors like to see a “deputy MR” identified. My advice is to have the CEO or President sufficiently trained that they can be the “back-up” when the MR is on vacation.

Every manager should know enough about their subordinate’s job duties that they can “fill in. MR’s should be involved in senior staff meetings too, but not necessarily at the same frequency as every other senior staff manager. Typically, operations and sales have the most frequent meetings with the CEO–often weekly. Finance generally is monthly. HR and the MR might be bi-monthly or quarterly. Communication of the status of quality objectives should be regular reports to all senior staff, but you don’t have to have a Management Review to communicate the status. If the company is small enough to have only one QA person, there probably isn’t a need for more than one or two management review meetings per year.

Management Representative Finding: 8 Proposed Actions to Take

If your company has a finding against clause 5.5.2, I recommend the following actions:

1. Assign a person that is already a member of your senior staff as MR.

2. Document the responsibility in the person’s job description.

3. Document the responsibility in the org chart.

4. Assign the person’s direct supervisor (typically the CEO or President) as a “deputy MR.”

5. Find an excellent webinar on ISO training for the new MR and their boss (ideally one with a quiz and a certificate).

6. Have the new MR develop a 45-minute presentation for the senior staff on the topic of Management Responsibilities. This training should cover all of section 5 in the Standard.

7. Give the senior staff a 15-minute multiple-choice quiz to evaluate the effectiveness of the training.

8. Have the new MR discuss the delegation of various management review inputs (see section 5.6.2) with their boss. Quality should be a shared responsibility, and Management Reviews will be more effective if everyone participates.

Posted in: ISO 9001:2008, ISO Certification

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