Guidance on corrective action and preventive action and related QMS processes GHTF/SG3/N18:2010
Should the nonconformity recur within the QMS, during manufacture or after the medical device has been delivered to a customer, it is an indication that improvement action(s) may be needed. In either case the QMS requires that a corrective action should be carried out with the aim to prevent recurrence. The corrective action may be as simple as retraining, or as complex as rede-signing the manufacturing process.
The manufacturer may encounter situations that have not actually caused a nonconformity, but may do so in the future. Such situations may call for preventive action. For example, production or acceptance testing trend data indicates that control limits are being approached and revision of product or production (process, equipment or facilities) requirements may be necessary. These revisions could constitute a preventive action. Preventive action would not include planned process adjustments intended to return process performance to nominal values from the edges of the process control range.
Actions taken to eliminate observed nonconformities within the scope of a single QMS (regard-less of whether the actions are taken at more than one site or facility operating within that QMS) would be considered corrective actions. However, similar actions applied within another QMS (regardless of whether it is the same site, facility, or organization) that has not yet experienced these nonconformities, would be considered preventive actions.
Figure 1 illustrates typical Phases to be considered when planning, implementing and maintain-ing effective processes for measurement, analysis, improvement and providing input to manage-ment. See Annex A for a list of possible activities corresponding to the phases in Figure 1.
As a check on the effectiveness of the processes defined, management should regularly review the outputs of processes and make adjustments as needed.
Documented procedures, requirements and records should be maintained by the manufacturer to ensure and demonstrate the effective planning, operation and control of the processes. Docu-mented evidence of decisions and actions taken will be a part of the QMS.
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Guidance on corrective action and preventive action and related QMS processes GHTF/SG3/N18:2010
4.0 Phase IPlanning4.1 Plan for Measurement, Analysis and Improvement Processes4.2 Establish Data Sources and CriteriaExamples of defined Data SourcesSupplier Performance/ControlsMarket / customer survey Quality Audits(internal / external)Returned ProductProcess Controls5.1 Measure and 5.2 Analysecoordination / linkage of data / data sources / “horizontal analysis”6.0 Phase IIIImprovement6.6 Determine Effectiveness of Implemented Actions6.1 Investigate6.2 Identify Root CauseImprovement6.3 Identify Actions6.5 Implement Actions6.4 Verify identified Actions7.0 Phase IVInput to Management7.1 Report to Management and 7.2 Management Review
Figure 1: Processes for measurement, analysis and improvement
4.0 Phase I: Planning
Planning involves specifying processes and associated resources in order to meet specific objec-tives. Factors to consider during the planning phase should be aligned with the manufacturer?s overall business planning and include the device?s intended use, markets and users, as well as regulatory requirements.
The involvement of management at appropriate levels (e.g. review, approval) in actions taken in response to nonconformities or potential nonconformities should be established. Management should ensure that measurement criteria are defined for identified data sources and communi-cated across the organization.
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Feedback Service ReportsComplaints5.0 Phase IIMeasurement and Analysis within and across Data SourcesWithin each data sourceSpare parts usageGuidance on corrective action and preventive action and related QMS processes GHTF/SG3/N18:2010
4.1 Plan for Measurement, Analysis and Improvement Processes
Factors to consider during this planning phase should be aligned with the manufacturer?s overall business planning and as a minimum include the type of device being manufactured, intended markets and users, and regulatory requirements. As part of planning, management should review the processes critical to the operations with regard to quality and regulatory requirements and select relevant data sources to measure, analyze and facilitate improvement as necessary.
In the process of planning measurement and analysis, a manufacturer needs to take into account data sources, the measurement of the data elements within each data source, the frequency of monitoring, and the analysis to be performed within a data source, or across data sources.
The measurement of data elements should be done in a way that ensures the manufacturer is ef-fective in managing the operations and maintain an effective QMS. Each of the data elements should be planned and established with specific requirements for measurement that are moni-tored routinely.
The scope of the QMS and the scope of the measurement, analysis and improvement processes will provide the boundaries as to whether the data source is reactive/corrective or proac-tive/preventive.
The planning phase should ensure the following:
? Identification of relevant internal and external data sources that are indicators of process and product performance.
? Provision for adequate resources and establish responsibilities and authorities to enable the necessary actions. Resources may include technical experts, testing laboratories, data management, infrastructure, training, etc.
? Definition of requirements for each identified data source, including limits, acceptance criteria, escalation criteria and mechanisms for reporting of nonconformities or potential nonconformities.
? Analysis of data elements within data sources.
? Coordination and analysis of data across data sources.
For each data element individual criteria should be defined; however, criteria may be defined for a combination of data elements. Criteria should be quantitative whenever possible in order to maximize consistency and reproducibility for subsequent analysis. If the criteria and data are qu-alitative, subjectivity should be eliminated or minimized.
Acceptance criteria should be based on system, product and process specifications or require-ments which are typically identified during design and development activities. This includes the design of the Quality Management System, development and maintenance of assembly processes, delivery processes, servicing and installation processes.
Escalation criteria used for the purpose of initiating the improvement process (see 6.0) may often be called action levels, trigger points, thresholds, etc. These escalation criteria should be proce-duralized and would likely include certain generic action levels as well as specific action levels resulting from risk management activities. In particular, criteria should be established for imme-November 4, 2010
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diate escalation. For example, an incident alleging a death or serious injury should be escalated to the improvement phase (see 6.0) for immediate action.
For new technology and existing technologies with new intended uses/applications, initial escala-tion criteria may be difficult to define for the monitoring process. Therefore a manufacturer should plan for resources to analyze information in order to confirm initial assumptions and es-tablish or revise escalation criteria.
Planning should provide for confirmation that the defined limits, acceptance criteria, escalation criteria and mechanisms for reporting of nonconformities or potential nonconformities for the original data sources and data elements are still appropriate. Where new data sources need to be established, confirm that they have been identified and their criteria defined.
4.2 Establish Data Sources and Criteria
The manufacturer should identify and document relevant data sources and their data elements, both internal and external to the organization. Data elements provide information regarding non-conformities, potential nonconformities and the effectiveness of the established processes within the data sources.
Examples of data sources can be, but are not restricted to: ? Regulatory Requirements ? Management Review
? Supplier (performance/controls) ? Complaint Handling ? Adverse Event Reporting ? Process Controls ? Finished Product
? Quality Audits (internal/external) ? Product Recall ? Spare Parts Usage ? Service Reports ? Returned Product
? Market/Customer Surveys ? Scientific Literature ? Media Sources
? Product Realization (design, purchasing, production and service and customer informa-tion)
? Risk Management
For further examples of data elements see Annex B.
When an issue is identified in one of the data sources, it is also important that the manufacturer identify and review related information from other data sources across the organization. Fur-thermore a review of information from external data sources should also be considered. The ag-gregation of information from more than the original data source may lead to more comprehen-November 4, 2010
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sive knowledge. With this knowledge base a manufacturer will be positioned to better determine appropriate action.
5.0 Phase II: Measurement and Analysis within and across Data Sources
Once data sources, data elements and acceptance criteria have been specified, as part of the plan-ning process, the manufacturer is required to perform measurement, monitoring and analysis processes to determine conformity or nonconformity.
Software used in measurement, monitoring and analysis, whether purchased (Off-The-Shelf) or custom developed, should be validated for its intended use.
For example, a customer survey conducted by the marketing department, indicated that there was a general dissatisfaction with the packaging of product X. When investigated further (within and across other data sources) and reviewed with other data from complaints, returned product and service reports, it became evident that there was a potential for misuse, unsafe use, or damage to the device as a result of the current packaging design. As the result of this analysis, escalation to Phase III (see 6.0) for preventive action may be appropriate.
5.1 Measure
For the purpose of this guidance, measurement is a set of operations to determine a value of a data element (i.e. quantity, quality).
Data collected from the measurement of product, process and QMS are acquired throughout the life-cycle of the product. The manufacturer should define for example frequency of the mea-surement, precision and accuracy of the data. The manufacturer should also ensure that the data collected is current and relevant.
Measurement data should be retained as a quality record. The manufacturer should maintain the data in a form that is retrievable, suitable for analysis and meets both QMS and regulatory re-quirements.
Monitoring is the systematic and regular collection of a measurement. The manufacturer should define during the planning phase what, when and how data should be monitored. The data should be defined such that it can be analyzed for further action. The monitoring of data may be conti-nuous or periodic, depending on the type of data source and elements. The monitoring processes should be periodically reviewed for their continued suitability.
5.2 Analyze
For the purpose of this guidance, analysis is a systematic review and evaluation of data from measurements to derive a conclusion.
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