The purpose of this whitepaper is to show the effectiveness of a well-structured management review process and prove that, by management reviewing quality indicators, they can instill into the company the immense importance of a highly developed Culture of Quality.

What Can You Do As A Quality Professional To Help Establish A Quality Culture Of Quality In Your Firm?

As one who previously worked at FDA and also in the Life Science industry as a RA/QA manager, Director of RA/QA and V.P of RA/QA, I came to realize that if quality was to be in the minds all management, it would have to be important to the person in charge, i.e. CEO or General Manger.  Of course, the extent to which a CEO assumes leadership in culture of quality, they must see the value in helping them in leading a successful company.

The Management Review Process

FDA has provided assistance to you as the quality officer in establishing the culture of quality when they wrote the FDA Quality System Regulation (21 CFR Part 820).   Specifically, Sec. 820.20 Management responsibility, “(c) Management review. Management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer’s established quality policy and objectives. The dates and results of quality system reviews shall be documented.

So how do you make Management Review be viewed as THE way to have the most successful company with a true culture of quality? This can be done by accepting the theory that you cannot manage what you cannot measure. Each functional area of the company should identify how they can provide data to show that their functional area is operating in a controlled manner that is efficient and effective. Thus, each functional area must identify what I refer to as “Quality Indicators.”

In the medical device regulation, it shows the need for a “Management Representative” for purposes of handling management reviews. Generally, this is the Quality Director or VP, but in any case, the CEO should decide who the Management Representative will be and establish the identity in a written document.

Quality Indicators

These are suggested Quality Indicators for each functional area of the company. These suggestions should be discussed by the executive in charge of each functional area and modified as needed to better fit your organization and allow for monitoring desired performance. For each functional area, the agreed upon quality indicators will be reported at each management review. The Management Representative will be responsible for collecting the Quality Indicators from each functional area and compiling the report for the management review.

We will now look at the suggested quality indicators for the following functional areas.

  • Sales and Marketing
  • Manufacturing
  • Quality Assurance
  • Research and Development
  • Clinical Studies
  • Personnel/Training

Quality Indicators for Sales and Marketing

  1. Sales Dollars per month
    • Total Sales, Sales by product category
  2. Dollars per salesperson per month
    • Average and range. A target goal should be identified.
  3. Dollars per account per month
    • This should be the five major accounts. The review should look at both positive and negative trends.
  4. New Customers per month
    • A reasonable goal should be established.
  5. Re-Orders per month
    • A key indicator of customer satisfaction

 Quality Indicators for Manufacturing

  1. Standard Cost
    • This is a standard accounting
  2. Yield/Scrap
    • An indicator of process control
  3. Material Cost
    • This is a standard accounting tool.
  4. Labor Cost
    • Finished units per Employee/work cell.
    • Becomes less important with automated process.
  5. Inventory Cost
    • This is a standard accounting tool.
  6. Days of Inventory
    • This is a standard accounting tool.
  7. Back Order Status
    • This should be trended towards a minimum value.

Quality Indicators for Quality Assurance

  1. Complaint Data by product type and complaint code
    • This is data that FDA reviews during inspections but is also valuable to monitor.
  2. CAPA data Number of new CAPA’s Number of CAPA closed, Number of overdue CAPA’s.
    • This is also data that FDA reviews, and it is important that the Management Review SOP contain a link to the CAPA program for quality indicators that are not acceptable.
  3. NCMR per month by products, process, or errors
    • Non-conforming materials must be monitored as indicators of problems.
  4. Receiving Inspection Efficiency – Average time to receive.
    • This should be monitored, and a minimum performance level be established.
  5. Number of documentation errors – Batch records or DHR’s
    • For automated quality assurance programs with electronic production documents, this indicator may not apply.
  6. Number and types of Material Review Board (MR0 decisions per month)
    • This indicator is valuable as MRB involvement should be minimal. If a trend shows an increase a root cause should be determined.

Quality Indicators for Research and Development

  1. Project Schedule adherence rate
    • Each project should monitor adherence to the approved product schedule. A delay should be identified, and potential corrective actions discussed if necessary.
  2. Design Review Schedule adherence rate
    • This is a key indicator for demonstrating FDA compliance and a key requirement for design control.
  3. Number of engineers per project
    • This should be reported and modified as might be necessary to correct problems.
  4. Failure rate of verification testing
    • Each verification protocol should identify expected acceptable outcomes. This will allow calculation of the failure rate and trends.
  5. Number of Design Changes per month in production for new products.
    • This quality indicator monitors the effectiveness of design control. The goal should be no design changes once the product has been turned over to production.
  6. Number of unanticipated failures in field related to design.
    • Field failures related to design should not occur if the design process is working correctly. However, this is a key indicator if it occurs, and the complaint processing process should identify root cause of failure and report it to the R & D operation if a defect in design is the root cause.

Quality Indicators for Clinical Studies

Most clinical trials today are managed by electronic systems, and as such, the following indicators may be captured electronically and reported. It is suggested that this ability to capture this data should be a criterion for selecting an electronic system to manage clinical trials:

  • Enrolment Rate per Site
  • Number of Errors per CRF
  • Number of Days to Receive CRF
  • Protocol Violations per Site
  • Compliance to Roll Out Schedule
  • Average Days to Start New Centers
  • IRB Approvals on First Pass

Personnel/Training Quality Indicators

It is common in some organizations for Human Resources to manage employee training. If in the case of your organization training is not managed by Human Resources, then the training indicators should apply to the other department:

  • Turnover Rate
  • Rate of Performance Appraisals on Time
  • Training Dollars per Employee
  • Adherence to Training Schedules
  • Employee Accident Rate
  • Time to Fill Open Positions

Clear Messages To The Employees On The Importance Of A Culture Of Quality

The CEO should address an all-employee meeting and present the plan to conduct a quarterly management review of the Quality Indicators. Each employes should identify the quality indicators that cover their responsibilities. The CEO should emphasize these efforts are designed to help everyone, all employees and all customers, and will allow for improvements to be made when needed.  For FDA regulated businesses the employees should know this effort will also show FDA compliance when evaluated during an FDA inspection

At future all-employee meetings, the CEO should recognize those departments that show improvement via the Quality Indicators. Public acknowledgment will encourage other departments so that they can be recognized at future meetings. It also shows how important Quality Indicators are to the CEO and the business.

How Do You Measure The Effectiveness Of Your Efforts?

The written record of each Management Review should document improvements noted from the previous review. In addition, the written record should include a report on corrective actions noted as required in the previous review.

Consider some type of meaningful reward, consistent with your overall company culture, for the functional managers who show consistently acceptable data regarding controls in their area. The reward will send a message to all employees on the importance of a Culture of Quality.

Now More Than Ever Quality & Regulatory Compliance Remains Critical

These are certainly unique times for the Pharmaceutical & MedTech manufacturing industry, and it could be helpful to work with Quality and Regulatory experts to navigate an unprecedented environment.

Premier FDA Solutions focuses solely on Quality and Regulatory compliance for the Life Sciences industry. Premier FDA Solutions will leverage its deep bench of expertise to keep your operations compliant, whether you need one consultant for a day or several FDA experts for a long-term project, we can provide the right scale at the right time.

Developing a culture of quality might sound daunting, but Premier FDA can make the process more manageable and streamlined. We are here to help your Life Science manufacturing be the best they can be. Contact Premier FDA today and Get FDA ready!

WRITTEN BY J. LAWRENCE STEVENS OF RAC OF ONE WAY CONSULTANTS, LLC FOR PREMIER FDA SOLUTIONS, LLC