ISO 13485 is a regulatory standard whose focus is meeting customer requirements, including regulatory requirements, and maintaining the effectiveness of the Quality Management System (QMS).
Section 5 of the standard requires management involvement and responsibility for the effectiveness of the QMS. The management review meeting represents the forum where process objectives, metrics, and goals are reviewed and assessed. The outcomes of the periodic assessments should be directly correlated to the continuous improvement requirements built into the ISO13485 standard.
ISO 13485:2003 carries an obligation to continually monitor and maintain the effectiveness of a QMS through improvement efforts. It’s more than just a regulatory requirement of the standard, the need to continually improve an organization’s operations, to become more productive, to use fewer raw materials, and to reduce energy usage are competitive advantages.
Given the importance placed on the management responsibility and continuous improvement aspects of the standard, one could ask “What types of data should be evaluated in a management review meeting?” Since all companies are different, a comprehensive answer is difficult to arrive at; however, there are certain data sets that are more universal than others.
It is also critical for organizations to realize that the data and parameters which are reviewed must be well-thought out and actionable, lest data is reviewed “for data’s sake” that ultimately renders the review process to be mired in minutia and unproductive discussions and actions.
Finally, the data should be tied to the quality objectives as defined in the Management Review Metrics Scorecard where there are clear definitions on what the objectives are, how they are measured, and what the acceptable targets are. While listed as broad categories below, each organization needs to “slice and dice” the data to ensure it provides a realistic view and is meaningful. The use of Pareto and other statistical charts is common.
So, what types of data are generally evaluated in management review meetings?
• Product failure and/or defect rates
• Customer complaints
• Customer complaint cycle times including “time to closure” and “average days open”
• Number of adverse effects
• Number of recalls
• Customer survey summaries
Quality System Effectiveness Feedback:
• Number of non-conforming events including tracking and trending of types, sources and impacts
• Non-conforming record or report (NCR) cycle times including time to closure, average days open, and quantity by department, etc.
• Number of CAPAs opened including tracking and trending of types, sources and impacts
• CAPA closure cycle time and average days open
• CAPA effectiveness review
• Number of planned deviations opened
• Internal audit status and result summaries
• Internal audit remediation schedules, results, and targeted due date status
Supplier Performance Feedback:
• Supplier performance scorecard review including business risk analysis as related to key suppliers and/or critical raw materials and/or services
• Supplier audit status and result summaries including the status of remediation efforts/projects
Manufacturing Performance Feedback:
• Percent yields, scrap rates, rework rates, etc.
• Percent of lots manufactured without a NCR or planned deviation
• Labor utilization (to verify there is sufficient strategic deployment of resources)
• Production schedule adherence and backorder rates
• Qualitative and quantitative metrics to correlate training program investment with an appropriate return. For example, is there data that indicates employee training translates to positive trends in terms of better workmanship (less product defects), decreases in non-conformance rates and sources, reduced customer complaints, improving internal audit results, etc?
Present data that answers the following questions:
• Do all CAPAs, NCRs, planned deviations, internal audits, supplier audits, and continuous improvement projects have owners assigned and is progress tangible?
• Are all cycle time metrics associated with the QMS healthy?
• Are open positions being actively recruited and filled?
Opportunities for Improvement:
• Review the status of continuous improvement projects already in-progress.
• Use the data reviewed in the meeting to determine if additional projects need to be initiated
Management Review Metrics Scorecard:
• Review the scorecard to determine the overall health and direction of the QMS.
Look for an upcoming blog that focuses on the Management Review Metrics Scorecard.