Guidance on corrective action and preventive action and related QMS processes GHTF/SG3/N18:2010
A failure to act is only considered a cause if there was a pre-existing requirement to act. The re-quirement to act may arise from a procedure, or may also arise from regulations, standards or guidelines for practice, or other reasonably expected actions.
Some of the more common tools and techniques include: ? Cause and effect diagrams ? 5 Why?s analysis ? Pareto charting
? Fishbone/Ishikawa cause and effect diagrams ? Change analysis
? Risk analysis techniques ? Is/Is Not
The outcome of an investigation should include: ? Clearly defined problem statement
? What information was gathered, reviewed and/or evaluated ? Results of the reviews/evaluations of the information ? Identification of cause(s) or contributing factors
? Solutions to address the cause(s) or contributing factor(s)
6.2 Identify Root Cause
Causes or contributing factors of detected nonconformity or potential nonconformity should promptly be identified so that corrective action can be taken to prevent recurrence, or preventive action taken to prevent occurrence. The process to identify the root cause should start with the output(s) of the investigation (see 6.1).
When assessing relevant data, the following should be considered:
? Systematic generation of cause and effect conclusions supported by documented evidence ? Evaluate significant or underlying causes and their relationship to the problem ? Ensure that causes are identified, not the symptoms
? Check for more than one root cause (above processes if necessary)
Causes or contributing factors of nonconformities or potential nonconformities may include the following:
? Failure of, or malfunction of, incoming materials, processes, tools, equipment or facilities in which products are processed, stored or handled, including the equipment and systems therein
? Inadequate or non-existent procedures and documentation ? Non-compliance with procedures ? Inadequate process control ? Inadequate scheduling ? Lack of training
? Inadequate working conditions
? Inadequate resources (human or material) ? (Inherent) process variability
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Guidance on corrective action and preventive action and related QMS processes GHTF/SG3/N18:2010
For further details on aspects to be considered when doing the root cause analysis see Annex C.
The output of the root cause analysis should be a clear statement of the most fundamental cause(s) resulting in the nonconformity (see Annex D for examples).
6.3 Identify Actions
When the root cause(s) has been determined, the manufacturer should identify and document the necessary corrections and/or corrective actions or preventive actions. These actions should be reviewed to ensure that all necessary actions are identified. The review may benefit from a cross functional approach. Where applicable, product disposition decisions should also be documented.
The following outcomes are possible and should be documented:
? No further action necessary
(provided that no safety issue exists and regulatory requirements are met) - With continuous monitoring
- Acceptance under concession and continuance of monitoring
? Correction
It may be necessary to take initial corrections (e.g. containment, stop of shipment/supply, issuance of advisory notice) in order to address an immediate risk or safety issue. This may be necessary before investigation has been completed and root cause has been de-termined. However, after investigation and root cause determination, additional and/or possibly different corrections may become necessary.
? Corrective action
Corrective action should address systemic problems. For example, changing the proce-dure and training of personnel to the revised procedure may not, by itself, be appropriate or sufficient to address the systemic cause(s).
? Preventive action
By its very nature preventive action can not follow a nonconformity.
As a result of this step, a list of action items should be documented. These may include: ? A detailed description of the implementation
? Review regulatory requirements (e.g. submissions, licensing, certifications) ? Roles and responsibilities for execution of action items
? Identification of the necessary resources (e.g. IT, infrastructure, work environment) ? Verification and/or validation protocols of the action(s) with acceptance criteria ? Implementation schedule, including timelines
? Method or data for the determination of effectiveness with acceptance criteria
? Identify the starting point of monitoring, and end point of correction and/or corrective ac-tion or preventive action as described above
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Guidance on corrective action and preventive action and related QMS processes GHTF/SG3/N18:2010
6.4 Verify Identified Actions
Before the implementation of action(s), a manufacturer should verify the identified action(s) and approve their implementation. In addition validation may be required where process validation or re-validation may be necessary, or where user needs or intended uses are changed and design va-lidation will be required.
Verification activities are to ensure that all the elements of the proposed action (documentation, training etc) will satisfy the requirements of the proposed action. These activities should be per-formed by persons who are knowledgeable in the design or use of the product or process that is the subject of corrective or preventive action. Verification of a preventive action can be accom-plished by introducing the conditions that would induce a nonconformity and confirming that the nonconformity does not occur.
Validation activities generate data and information that confirm the likelihood of the effective-ness of the corrective action to eliminate the nonconformity or proposed nonconformity.
Examples of items to be considered when planning the verification/validation activities include: ? Does the action(s) eliminate the identified root cause(s)? ? Does the action(s) cover all affected products/processes? ? Does the action(s) adversely affect the final products?
? Is it possible to finalize the actions timely in planned schedule (resources, materials/kits, logistics, communications, etc.)? ? Is the execution of the action commensurate with the degree of risk previously established?
? Are new risks or nonconformities derived from the action?
6.5 Implement Actions
The following items that may be considered at implementation should be documented: ? Parties involved ? Materials ? Processes ? Training
? Communications ? Tools
? Timelines for the implementation of the approved action
Verify that the implementation has been completed.
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Guidance on corrective action and preventive action and related QMS processes GHTF/SG3/N18:2010
6.6 Determine Effectiveness of Implemented Actions
The manufacturer should gather data over a period of time related to the effectiveness of the im-plemented action (see Annex D for examples).
Management should ensure and be involved in a review and confirmation that actions taken were effective and did not introduce new issues or concerns. The following questions should be consi-dered at appropriate times throughout the process and be revisited in the final review: ? Has the problem been comprehensively identified?
? Has the extent of the problem been identified (e.g. range of affected devices, patient out-come, process, production lines, operator)?
? Have the root cause/contributing factors of the problem been identified and addressed? ? Has the improvement action(s) been defined, planned, documented, verified and imple-mented?
If the manufacturer finds the actions are not effective, the manufacturer should re-initiate Phase III activities (see 6.0). If the manufacturer finds the actions create a new issue or a new noncon-formity then the manufacturer needs to initiate Phase II (see 5.0) activities.
7.0 Phase IV: Input to Management
Management at different levels in the organization should be involved in each improvement ac-tion either through approval of the improvement steps or reporting.
The Management Review is the overall mechanism for management to ensure that the Quality Management System as a whole is effective.
7.1 Report to Management
The manufacturer should have a mechanism/procedure that expeditiously raises safety related issues or other high risk issues to management. These issues can be identified in the data sources, the improvement phase (see 6.0), or originate from other sources external to the Quality Man-agement System. In addition to this expeditious escalation mechanism, the manufacturer should define management and personnel responsibilities (i.e. process owner) for the measurement, analysis and improvement processes, to ensure that the processes and the actions being imple-mented are effective. For this purpose there needs to be a mechanism for management at differ-ent levels to stay informed of the information or data from:
? The measurement and analysis activities from the individual data sources
? The investigations, actions, implementations, etc. from the improvement processes
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Guidance on corrective action and preventive action and related QMS processes GHTF/SG3/N18:2010
7.2 Management Review
The manufacturer has procedures for what is provided as input for the management review, in-cluding relevant information from the improvement processes, such as improvement actions (corrective actions, and/or preventive actions) as well as important corrections.
The manufacturer needs to define what meaningful data is to be reported for a management re-view. Data should be specific to the quality objectives of the manufacturer and be reported regu-larly. Merely providing the number of improvement actions or the number of how many im-provement actions are opened or closed to the management review process are not sufficient in assessing the effectiveness of the processes.
Included in this review would be an assessment of any opportunities for improvement of the de-vice, manufacturing process, QMS or the organization itself.
An outcome of the review could be the allocation of funding or personnel to a particular area, project or device that the review has identified as not meeting customer and regulatory safety and effectiveness expectations.
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