All organizations with a focus on quality need to conform to requirements in ISO 9001 to maintain customer satisfaction and provide superior products and services. Medical device organizations also need to conform to requirements in ISO 13485 to maintain high levels of safety, to minimize risk, and meet regulatory requirements. Both standards require top management to review the organization quality system at planned intervals. In addition, the later standard requires documented evidence of the Quality System Management Review (QSMR) “The organization shall document procedures for management review. Top management shall review the organization’s quality management system at documented planned intervals to ensure its continuing suitability, adequacy, and effectiveness. The review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives.”, as stated in ISO 13485:2016 Medical devices.
Organizations regardless of size and type face challenges to conform with management review regulatory requirements. Here are some examples we heard from our customers related to this area:
How can we streamline the periodic reviews and demonstrate business value gains and cost savings?
Executive management sees management reviews as dull and time consuming tasks that need to be done to maintain compliance. How can we engage them and do the management review in an efficient way that helps the company by focusing efforts on key issues?
How do we effectively provide visibility and insight to executive management without spending days putting together power point presentations?
How do we significantly reduce non-value added work?
Follow up action items get lost and are difficult to track. How can we automate the QSMR process and make it more effective?
Your organization can maintain the suitability, adequacy and effectiveness of its Quality System through a range of activities including management reviews. In this blog, we have put together 5 benefits of investing in a tool that automates your quality system management review.
1- Eliminate inefficient manual processes for management representatives
Per ISO 13484, top management shall designate a member of management as its management representative. Among other responsibilities, management representatives need to document quality system processes, and report the effectiveness of the quality system to top management. They need to improve awareness of applicable regulatory requirements and quality management system requirements throughout their responsibility area such as at site, business unit, or corporate levels. Using a tool allows management representatives to:
Address tougher regulatory requirements through an out of box scheduled QSMR compliant process
Start with an out of box compliant process with required management review inputs and outputs and modify it to fit your specific metrics and review cycles
Communicate management reviews effectively and in consistent basis across the enterprise
Gain cost savings by reducing the time it takes to perform a review from multiple weeks of preparation down to hours
2- Identify improvement opportunities and reduce risk globally
We hear from our customers that they have little visibility into process data across geographies, making root cause analysis and trending inefficient. Measurement, analysis, and improvement is a key requirement in ISO 13485. The management representative can delegate authority for management review activities to others in the organization. For example, the management representative delegates responsibility for the Complaints process improvement to the Complaints process owner. Organizations define a set of metrics and threshold levels that are aligned with the organization’s business plans. An automated tool helps process owners meet their responsibilities since the tool:
Includes analytical dashboards that are used to visually track and analyze data from different data sources for each process such as complaints and eliminates the needs for manually using spreadsheets to analyze data points.
Facilitates identification of trigger points and when threshold levels are exceeded for the various key performance indicators. The tool allows for customization of views at site level, business unit level, or roll up to global level to monitor the health of a specific process, regional area or the global business.
Displays analyzed results in effectiveness pleasing dashboards that eliminate the need for manual creation of power point slides for the management review meeting. A business process owner may apply filters to assess performance over the previous period since the last management review meeting.
Reduces risk by identifying trends and discovering insight from the large amount of data analyzed. It provides the information necessary to create a strong plan for improvement to address identified weaknesses, facilitate investigating root cause, and identify actions to correct.
3- Collect all QSMR artifacts in one repository
“Records shall be maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system.” ISO 13485. An automated tool for QSMR serves the need for being a central repository for QSMR artifacts. A QSMR process is represented as a record in the tool with its inputs, outputs, and linked processes. Current and previous QSMR records are also linked. We hear from our customers that they need a compliant electronic QSMR solution to replace their current hybrid approach that relies on documents and non-compliant data collection methods. A central repository helps provide:
All QSMR inputs, outputs and dashboards are managed in a central location
A site QSMR, business unit QSMR, and corporate QSMR can be linked together to provide an organization view
Easy auditing since the records of the management review are kept as evidence
Inputs to the QSMR such as internal audits, external audits, effectives SOPs and quality policy from the document management system can be integrated to the QSMR record
4- Provide visibility and insight to top management
We heard from our customers that top management does not appreciate the lengthy dull power point presentations put together manually. Top management want to see executive level dashboards that show through easy visuals and colors for example green, yellow or red the overall health of a unit or a business. Intuitive icons with up arrows or down arrows for example show trends quickly. Benefits for an automated QSMR include:
Management representative and process owners can engage top management in a review process that drives value added activities and focuses on key risks, provides ability to drill into risk maps as an example to ensure the organization is spending time on the most value-added action items.
Process owners can provide easy digestible information based on the data and dashboards highlighting key findings and actions to address. They come back to top management with key takeaways and a plan for improvement. Top management can make informed decisions. When they review, and approve the plan, it gets documented in the QSMR record.
Management reviews become easier by following an automated process with workflows based on industry best practices, approval and attendance e-signatures for audit trail as objectives evidence of the review meeting, and system generated notifications and reminders.
Enable evidence based decision making. Decisions are made based on analysis of up to date quality, product, and customer data.
5- Manage and track continuous improvements
Leading up to and during management review meetings, improvement opportunities and changes to address risks are identified and planned as follow up actions. Top management needs to ensure that these actions are tracked and are implemented to address risks and opportunities and expected results are achieved. The follow up actions identified may be tracked manually in a project plan. However, tracking them in a QSMR tool and linking them to the QSMR record ensures that they are acted upon and completed on time. An automated QSMR tool provides:
Easy tracking of follow up actions. Actions are not buried in project plans and managed manually but rather through a tool with automated workflows, improving efficiency and completion time.
Ability to monitor and report on related processes such as CAPAs that are created to address a finding from the analysis phase.
Enhanced collaboration and increased transparency and accountability across the organization and the supply chain.
Effectiveness check measurements for changes implemented as a result of the QSMR.
Stay tuned for more innovations from Sparta Systems.