Guidance on corrective action and preventive action and related QMS processes GHTF/SG3/N18:2010
The manufacturer should have documented procedures for the analysis of data against the estab-lished criteria (see 4.1). Analysis is performed to identify nonconformity or potential noncon-formity or identify areas where further investigation should be initiated. In addition analysis is used to demonstrate the suitability and effectiveness of product, process and QMS. Analysis can be performed utilizing analytical tools, a team of experts, process owners or independent review-ers. The results of the analysis should be documented.
After it is determined what will be measured, statistical techniques should be identified to help understand variability and thereby help the manufacturer to maintain or improve effectiveness and efficiency. These techniques also facilitate better use of available data to assist in decision making. Statistical techniques assist in identifying, measuring, analyzing, interpreting and mod-eling variability.
For the analysis of nonconformity, appropriate statistical and non-statistical techniques can be applied. Examples for statistical techniques are: ? Statistical Process Control (SPC) charts ? Pareto analysis ? Data trending
? Linear and non-linear regression analysis
? Experimental design (DOE – Design of Experiments) and analysis of variance ? Graphical methods (histograms, scatter plots, etc.)
Non-statistical techniques are for example: ? Management reviews
? Results from quality meetings
? Safety committees (internal/external)
? Failure Mode and Effect Analysis (FMEA) ? Fault Tree Analysis (FTA)
Analysis will likely occur at several different points (time and/or organizational level). For ex-ample, a certain amount of analysis and possible failure investigation (where there is evidence of a nonconformity) will occur for each data source.
In addition to the analysis within the data sources there should also be a level of analysis across data sources to determine the extent and significance of nonconformity or potential nonconformi-ty. The linkage of data from different data sources will be referred to as “horizontal analysis”. The horizontal analysis may:
? determine that the action proposed from the data source analysis is appropriate without further progress into Phase III (see 6.0); or,
? provide additional information warranting progress into Phase III (see 6.0), regardless of whether the data source analysis escalated the nonconformity or potential nonconformity.
The outcome of measurement and analysis leads to different scenarios as shown in Figure 2.
November 4, 2010 Page 11 of 26
Guidance on corrective action and preventive action and related QMS processes GHTF/SG3/N18:2010
No CorrectionCorrectionProgress toPhase IIIProgress toPhase IIIAmonitorBmonitorCorrectionCmonitorDanalyzemonitormeasureanalyzeanalyzeanalyzemeasuremeasuremeasure
Figure 2: Outcomes of measurement and analysis
The following tables provide more details to support the use of Figure 2. Each scenario is de-scribed with an example showing the different outcome of measurement and analysis. Basic The documentation requirements in a research design and development procedure Example were not followed. The missing documentation involves changing to a different supplier of an electronic board. The requirement is to document the supplier name and supplier number in the research report. Scenario A No correction required, continue measurement and monitoring The decision is made not to take any correction nor escalate the handling of the nonconformity to Phase III (see 6.0). Example Nonconformity Key Results of Measurement and Analysis Conclusion The supplier number was not included in the research report. (however, the supplier name is documented). Analysis indicates that the procedure is adequate and well known to the us-ers of the research procedure. Following a review of the issue this appears to be a one time oversight. The intent of the requirement is for convenience only. No initial correction - It is not necessary to update the research report, as the supplier is documented by name, hence traceability is maintained. Do not escalate to Phase III. Scenario B Correction required, continue measurement and monitoring Example The decision is made to perform a correction but not to escalate the handling of the nonconformity to Phase III (see 6.0). Nonconformity Key Results of Measurement and Analysis The supplier name and number was not included in the research report. Analysis indicates that the procedure is adequate and well known to the us-ers of the research procedure. Following a review of the issue this appears to be a one time oversight. The intent of the requirement is to ensure traceability to the supplier and this could be lost if the research report is not updated. Take an initial correction to update the research report with the supplier name and number. Do not escalate to Phase III. Conclusion
November 4, 2010
Page 12 of 26
Guidance on corrective action and preventive action and related QMS processes GHTF/SG3/N18:2010
Scenario C Correction and escalation to further investigation under the improvement phase. The decision is made to perform an initial correction. However, there is a need for escalation to Phase III (see 6.0) to further investigate as a result of the analysis performed in order to determine the appropriate corrective action. Example Nonconformity Key Results of Measurement and Analysis The supplier name and number was not included in the research report. Analysis indicates that the procedure may not be adequate and it is not well know to the users of the research procedure. The issue has been identified in multiple reports. In some cases, traceability to the supplier could be established via other means, and in other cases it could not. Take an initial correction to update the research report with the supplier name and number (in the cases where the supplier could be identified). Escalate to Phase III for corrective action. Conclusion Scenario D Escalation for further investigation under the improvement phase. Example The decision is made that there is not enough information at this time to determine the required action. Therefore the investigation is escalated to Phase III. Nonconformity Key Results of Measurement and Analysis Conclusion The supplier name and number was not included in the research report. Analysis indicates that the procedure may not be adequate and it is not well know to the users of the research procedure. The issue has been identified in multiple reports. Traceability to the supplier could not be established via other means in any of the cases. No initial correction - The supplier is not known so an initial correction can-not be taken at this time. Escalate to Phase III for corrective action.
Documented procedures should clearly delineate and define when escalation to Phase III is re-quired.
Typically manufacturers have organizational groups or processes surrounding some of their main data sources (e.g. complaint handling, handling of nonconformities, material review boards, change management process). Within these groups or processes certain activities described in Figure 2 can be implemented without escalation.
There may be predefined events that due to the significance of the risk will be escalated to Phase III without any delay that can not be justified. In the event a potential nonconformity is identified, it may be escalated into Phase III (see 6.0) for consideration of actions to prevent the occurrence of the potential nonconformity.
When no correction or only corrections within these groups or processes are taken, there needs to be data source monitoring and analysis (e.g. trending) to determine if escalation to Phase III may be necessary from accumulated information. Whenever an issue is escalated to Phase III, any in-formation gained within the defined activities of these groups or processes should be an input to the Phase III activities such as Investigation (see 6.1) or Identified Actions (see 6.3).
November 4, 2010
Page 13 of 26
Guidance on corrective action and preventive action and related QMS processes GHTF/SG3/N18:2010
6.0 Phase III: Improvement
The improvement phase of a corrective action process or preventive action process is designed to eliminate or mitigate a nonconformity or potential nonconformity.
The improvement activities are dependant on the specific nonconformity or potential noncon-formity. Any previous data from Phase II should be utilized as input to the Phase III process.
The improvement phase and the activities described in Figure 3 needs to be documented. Im-provement generally involves the following activities that the manufacturer would take sequen-tially or sometimes simultaneously:
? A thorough investigation of the reported nonconformity ? An in-depth root cause analysis ? Identification of appropriate actions ? Verification of identified actions ? Implementation of actions
? Effectiveness check of implemented actions
6.1 Investigate6.6 Determine Effectiveness of Implemented Actions6.2 Identify Root CauseImprovement6.3 Identify Actions6.5 Implement Actions6.4 Verification of identified ActionsFigure 3: Phase III – Improvement
6.1 Investigate
The purpose of investigation is to determine the root cause of existing or potential non –conformities, whenever possible, and to provide recommendations of solutions. The magni-tude/scope of the investigation should be commensurate with the determined risk of the noncon-formity.
Good practice shows that a documented plan should be in place prior to conducting the investi-gation (see Annex D for examples). The plan should include:
? Description of the nonconformity expressed as a problem statement ? Scope of the investigation
? Investigation team and their responsibilities ? Description of activities to be performed ? Resources
? Methods and tools ? Timeframe
November 4, 2010
Page 14 of 26
Guidance on corrective action and preventive action and related QMS processes GHTF/SG3/N18:2010
From the information obtained throughout the process the problem statement should be reviewed and refined as appropriate.
The investigation should:
? Determine the extent of the nonconformity or potential nonconformity
? Acknowledge that there are likely to be several causes of an event; hence, the investiga-tion should not cease prematurely
? Require that symptoms be distinguished from root causes and advocate the treatment of root causes rather than just the symptoms
? Require that an end point be defined for the investigation. An overly exhaustive investi-gation may unduly delay the correction of non-conformity or unnecessarily incur addi-tional cost. (For example, if removal of the causes identified so far will correct 80% of the effects then it is likely that the significant causes have been identified (Pareto rule)) ? Take into account the output of relevant risk management activities ? Agree on the form of evidence. For example, evidence should support: - the seriousness of the event
- the likelihood of occurrence of the event
- the significance of the consequences flowing from the event
The investigation should include the collection of data to facilitate analysis and should build upon any analysis, evaluation and investigation that were previously performed (see 5.0). This will require the investigator to identify, define and further document the observed effects/non-conformity, or already determined causes, to ensure that the investigator understands the context and extent of the investigation. It may be necessary to: ? Review and clarify the information provided
? Review any additional information available from an horizontal analysis ? Consider whether this is a systemic issue/non-systemic issue ? Gather additional evidence, if required
? Interview process owners/operators or other parties involved ? Review documents
? Inspect facilities, or the environment of the event
Previous investigations should be reviewed in order to determine if the event is a new problem or the recurrence of a previous problem where, for example, an ineffective solution was imple-mented. The following questions will assist in making the determination: ? Is the nonconformity from a single data source?
? Does the current nonconformity correlate with nonconformities from other data sources? ? Are multiple data sources identifying the same nonconformity?
? Do other nonconformities have an effect on the problem investigated here?
Many of the tools used in investigations rely upon a cause and effect relationship between an event and a symptom of that event. To ensure that causes are identified, not symptoms, the fol-lowing should be considered:
? There must be a clear description of a cause and its effect. The link between the cause and the undesirable outcome needs to be described.
? Each description of a cause must also describe the combined conditions that contribute to the undesired effect
November 4, 2010
Page 15 of 26