co10060015 corrective and preventive action...

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This document is electronically controlled. Printed copies are considered uncontrolled. Medtronic Confidential

Procedure and Work Instruction Template MPR-DOC-TMP-008418, Revision 3 Father / Parent Document: MPR-DOC-WI-008987

MPR-CPA-WI-009001 Revision 4 Change Order # CO10060015

Document Type Corrective and Preventive Action Process

Quality System Element

Corrective and Preventive Action

Scope All personnel owning and managing Corrective Action and Preventive Actions in Medtronic Puerto Rico Operations Company (MPROC). The requirements contained in this procedure will apply to new CAPAs or when a CAPA opened prior to the first release date of this procedure moves to the next phase in the life cycle.

Purpose Define the procedure to be followed for the CAPA process.

030 - Corporate Policy Corrective and Preventive Action

030-028 – Corporate Guidance Corrective and Preventive Action

MPR-CPA-PP-009000, Corrective and Preventive Action Policy

MPR-CPA-WI-009002, Event Generation

MPR-CPA-WI-009004, GCAPA User Guide

MPR-CPA-FRM-009017, Extension Request Form

MPR-CPA-JTS-009005, Investigation and Root Cause Analysis Summary

MPR-CPA-JTS-009014, CAPA Phase Review Checklists

Reference Documents

MPR-CPA-JTS-009015, Human Error Analysis Tool

Groups or Functions Impacted

Quality, Engineering and Manufacturing

Records and Maintenance

Record Description Start of Retention

Period Record Code1

N/A N/A N/A 1See Corporate Retention Schedule for record code definitions and length of time to retain the record.

MPR-CPA-WI-009001, Revision 4 of 47 Corrective Action Preventive Action Process



A. Change Information

Reason for Change Process Improvement

Background / Why is Required

In response to QIP PHO initiative and process improvement.

In Definitions, Abbreviations and Acronyms Section B, Initial Containment Date definition was updated, MHN abbreviation was removed and QH abbreviation was included.

It was included in CAPA Board responsibilities section D that the Business Unit Quality Manager is responsible to notify the Division Quality Management of the corresponding Business unit when there is affected product in DC, in transit to DC to determine if PHO is required.

• It was included in Section 2.4.4 to create an investigation task type to track the completion of the FMEA document update when the internal risk assessment determine that is required and update to FMEA.

• It was included in section 2.4.6 table, an instruction to provide seven (7) days to provide required information when event record has deficiencies, and to add rationale for due date change.

It was included in section 2.4.7 a question to verify if the event record has pending actions to be completed.

It was included in section 2.4.9 an instruction to provide seven (7) days to provide required information when event record has deficiencies, and a note that the event record shall not be closed if there are pending actions to be completed.

Add in section 2.5.6 an instruction to the Board Contact to change the due date when monitoring period ends or when the requested information is gathered to be presented in the next CAPA board meeting.

Clarify section 2.18 in which Quality Manager needs to notify the BU when there ir product in the field to determine further actions.

Include a note in section 3.3 to to document a justification if no PHO or Field Action was issued.

Description of Change

Add in section 3.11 an instruction in which the CAPA owner will include the investigation report (MPR-CPA-JTS-009005) and the supporting evidence in an Attachment task type (this attachment will be opened until the critical review activities are close done).




Justification for Change

It is necessary to notify Business Units when there is affected product with a non-conformance in transit to Distribution Center or in Distribution Center to request Risk Assessment from BU. Also identifies process improvement feedback was included.

Process Section Affected

Sections B, D, and 2.0




B. Definitions and Acronyms

Term Definition / Description

Awareness Training Training offered to all personnel certified in a specific area/process in order to notify a quality event has been identified. The purpose is to prevent recurrence of the event.

Bounding

Identification of the product or components affected by a non-conforming event with the potential of non-detection.

CAPA Corrective Action Preventive Action. It is a mechanism to: collect and trend information on existing or potential quality events, analyze and investigate the quality events to identify root cause, take appropriate corrective action and/or preventive action and monitor the effectiveness of corrective and/or preventive actions.

CAPA Owner

The individual assigned by the CAPA Board to manage the completion of the CAPA activities. The role in GCAPA is known as Event Owner or GCAPA Owner.

CAPA Start Date Refers to the date an Event is determined to be a CAPA by the CAPA Board.

Comment A note that is included in certain document to provide specific information for clarification purposes.

Containment Steps taken to prevent the release or spread of a potential or existing nonconformity.

Correction Immediate steps taken to eliminate a detected nonconformance. These steps can be done without knowledge of root cause.

Corrective Action Action taken to eliminate the cause(s) of a detected nonconformity, defect, or other undesirable situation in order to prevent recurrence.

Critical Review Review of the CAPA at a specific phase for proper scope, conclusions and content.

Critical Reviewer Board member assigned to review a CAPA at the investigation phase for proper scope, conclusion and content.

Date confirmed Date a data source owner identifies an issue that meets the criteria to escalate for consideration to CAPA.

Date occurred Date a quality event occurs. Designee Any employee with training and/or knowledge and/or educational

background on equipment, product, process, system that can act or take decisions on behalf of the main responsible person.

Effectiveness Monitoring or assessments taken after implementation or deployment of





Evaluation (Measure/Check)

Corrective or Preventive Actions to ensure the Actions accomplish their intended purpose.

FCA Field Corrective Action GCAPA System Global Corrective and Preventive Action (GCAPA) System Initial Containment Date Earliest Product Hold Order approval date. Investigation Review of an event to determine the scope and depth of an issue in

order to determine the root cause. Mitigation Steps taken to alleviate or lessen an issue; include corrections and

containment. These are typically required when an issue is first identified but may also be required throughout the CAPA life cycle.

Monitor GCAPA state that allows the collection of data to determine whether an investigation of an event is conducted formally.

Nonconformance A non – fulfillment (deviation) of a specified requirement established in a product / process /material specification, quality system procedure or company policy.

PHO Product Hold Order Post Any Activity A dynamic section of GCAPA that allows the user to change the state of

the record allowing the progress through the CAPA life cycle. PR Project record is the basic, or default name, for a record within the

GCAPA. Each PR has a unique number, which is generated by the system. The PR number is the unique identifier (primary key) for all e-records in the system.

PR state State that denotes the status of the PR in the GCAPA workflow. Preventive Action Action taken to eliminate the cause of a potential nonconformity, defect,

or other undesirable situation in order to prevent occurrence. Process cause A non-conformance root cause reason due to a gap in policy, process or

behavior that led to a technical cause or allowed a technical cause to occur. May have multiple levels.

Product in the field Product is now or once was beyond a Medtronic controlled distribution center and has the condition identified in the CAPA.

PRR Product Review Request QA Hold Quality Hold in Factory Works system Risk Analysis A systematic use of available information to identify hazards and to

estimate risk. Root Cause Analysis The documented analysis necessary to determine the original or true

cause of a system, product, or process problem. This effort extends beyond the effects of a problem to discover its most fundamental cause.

Task Originator Individual that creates and assigns tasks to Task Owner through the CAPA life cycle.

Technical cause An immediate reason of why a symptom(s) occurred. May have multiple





levels. TrackWise Medtronic Global Corrective and Preventive Action electronic application

used to record objective evidence of CAPA investigations. Validation Confirmation through provision of objective evidence that the

requirements for a specific intended use or application have been fulfilled. The use conditions for validation can be real or simulated.

Verification Confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.




C. Process Flowchart




D. Responsibility

Role Responsibility

CAPA Board • Determines CAPA level

• Assigns CAPA Owners

• Assigns CAPA Priorities

• Approves CAPA plans and phase closure (may be done through a designee)

• Escalates resource constraints to appropriate management

• Approve any rationale or deviations that are required (may be done through a designee)

• Determines if the scope of event need to be expanded to the MPROC, Business or Global CAPA Board.

• Ensures that information related to quality problems or non-conforming product is disseminated to those directly responsible for assuring the quality of such product or the prevention of such event.

• Business Unit Quality Manager is responsible to notify the Division Quality Management of the corresponding Business unit when there is affected product in DC, in transit to DC to determine if PHO is required.

CAPA Board Contact • Reviews the CAPA record for compliance to CAPA process.

• Completes Root Cause Analysis, Action and Effectiveness planning, checklists and escalates to CAPA Board any discrepancies that result from them.

• Executes on behalf of the CAPA Board in GCAPA.

• Requires the Board Member Certification.

• Ensures that the CAPA Owner is certified on the system.

CAPA Board Member • Controls resources and timeline and have decision making authority.

• Reviews investigation and root cause analysis records for completeness and adequacy.

• Reviews and approves CAPA action and effectiveness plans to ensure support from the appropriate resources and are aligned with organizational objectives and timelines.

• Escalates resources issues to appropriate management.

• The role in GCAPA is known as GCAPA Board Member. It requires




Role Responsibility

the Board Member Certification.

CAPA Coordinator • Individual with the required access to move CAPAs into correction states and add or modify information to a CAPA post closure.

• This role is restricted to assignment within the GCAPA Core Team and requires approval by the global GCAPA leader.

• The role in GCAPA is known as GCAPA Coordinator. It requires the CAPA Coordinator Certification.

CAPA Owner

• The individual assigned by the CAPA Board to manage the

completion of the CAPA activities. The role in GCAPA is known as Event Owner or GCAPA owner. It requires GCAPA Owner Certification.

• Responsible to complete the certification for the CAPA Owner role.

• Coordinates investigation and Action Plan (CAPA) activities through completion and define Effectiveness.

• Contacts the Task Owner to agree on the task is being assigned.

• Ensures that individuals assigned to complete tasks have completed the Task Owner training.

• Responsible to escalate any action out of the site scope to the CAPA Board for management or facility review. Actions may include but are not limited to, design changes, process changes, and Quality System changes.

Critical Reviewer • CAPA Board Member responsible of conducting a critical review when the Investigation phase is completed and before moving the record to the Action phase.

Peer Reviewer • Individual assigned to approve a task when a CAPA Owner is the same as a task originator.

• Must be a certified CAPA Owner or a trained CAPA Board member. Task Originator • Generates and approves tasks in GCAPA

• Responsible to complete required CAPA and GCAPA trainings

Task Owner • Responsible to complete the GCAPA Viewer Certification and required CAPA training.

• Responsible for on time completion of the task assigned by the Task Originator.

• Provides evidence (as applicable) to support task’s completion.




E. Instructions

1.0 Sections

1.1 For the Event Generation process, refer to MPR-CPA-WI-009002. For specific instructions on how to use GCAPA TrackWise, refer to MPR-CPA-WI-009004, GCAPA User Guide.

2.0 Assessment Phase

The goal of the Assessment phase is to decide whether to escalate an Event to a CAPA, considering impact to patient safety, business, regulatory compliance, input source process requirements, and customer satisfaction. Rationale of the decision making shall be documented.

2.1 The CAPA Board will evaluate the event within the timing requirements specified in the table below:

Action Conditions Time Requirements

If there is affected product in the field

Seven (7) calendar days from date confirmed

CAPA Board - performs assessment of event If there is no affected

product in the field 14 calendar days from date confirmed




2.2 The Board Contact must complete a search for related CAPAs/events including closed Event records for a minimum of a rolling year back and document the search criteria used in the Related Event Search Approach field in GCAPA. This field is required to assess events for escalation. It is intended to document the search for related or recurring events in GCAPA and define what the relationship is. Search criteria should be documented to facilitate the retrieval of the search for future occasions. The search criteria could be keywords such as product model number or product family.

2.3 In case that the Related Event Search results in a repeated non-conformance, bounding activities must be performed to ensure products manufactured between non-conforming events are properly examined for the same issue.

2.4 When making the event assessment, the CAPA Board:

2.4.1 Reviews the data on the Event Information tab for record adequacy and completeness.

2.4.2 Determines if the assigned Board is correct. If not discuss, agrees and re-assigns the event to the correct Board.

2.4.3 Determines if the scope of the event will be expanded to the MPROC Board.

2.4.4 The Board Contact or Board Member review the internal risk assessment, mitigations and analysis of related events. These fields/tasks must be completed before select the Closed with Justification. In case the internal risk assessment determines the FMEA requires update, create an Investigation task type to track the completion of the document update.

2.4.5 If Product affected is selected as yes, the Board Contact reviews the mitigation for the product bounding (why, when and how) and its rationale for that bounding. Also, the product disposition must be documented in the record (when applicable). Reference of PRR or quality hold shall be included (when applicable).

2.4.6 The Board Contact reviews the record using the Board Assessment Checklist contained in the MPR-CPA-JTS-009014, CAPA Phase Review Checklists.




If Then

The Event record has deficiencies.

• The Board Contact communicates with the Initiator to point out the deficiencies in the record and to work on the strategy for correct it. Seven (7) days will be provided to include the required information. Rationale for due date change will be included.

• The Initiator makes the necessary corrections the record.

2.4.7 Once all the event information is complete, the CAPA Board should answer the following questions when assessing the record for closure:

• Does the event record have enough information to assess a rationale for closure?

• If the issue in the Event encompasses more than one defect, noncompliance or quality concern, does the rationale for closure apply to all of them?

• Does the rationale for closure properly apply to one or more of the rejection reasons?

• Does the event record have pending actions to be completed? (e.g. FMEA update, Dissemination activities, etc).

2.4.8 The Board may close an Event for the following reasons:

• The problem does not comply with event confirmation guideline.

• The issue is a duplicate of an existing record and it is referenced in the Related Event Search Approach and/or Related Event #(s) field.

• The issue is addressed through another quality process and this quality process is referenced in the Close with Justification field.

• Data is insufficient to support confirmation of the problem.

2.4.9 The Board Contact reviews the record using the Closed with Justification Checklist contained in the MPR-CPA-JTS-009014, CAPA Phase Review Checklists. If deficiencies are found the Board Contact will provide 7 days for the corrections. Note: Event record shall not be closed if there are pending actions to be completed.

When an event is not escalated to CAPA, the record is completed by selecting the Closed/Justify disposition in GCAPA rationale for closure is included in the Close with Justification field.




2.4.10 The Board Contact opens an Investigation task called Rationale for Closure and assigns it to the Board Chair or Board Member. This task is to document the assessment done by the CAPA Board by answering the questions used to assess the record for closure.

2.4.11 The Rationale for Closure task is approved by the Board Contact.

2.4.12 The task owner and the Board Contact have seven (7) days to complete and approve the task.

If Then

The Event is not escalated to CAPA by the CAPA Board and record is complete and accurate,

• The Board Contact on behalf of the Board completes the closure process selecting the decision of Closed/Justify. A justification explanation is required in the Close with Justification field.

A signature at this process step means: The Event has been reviewed, an accurate and adequate description of the problem has been documented in the Event, the justification for closure has been entered, and the reason for closure complies with the CAPA procedure. This signature must be performed by a Board Member with GCAPA Board Access.

2.5 During the assessment of the Event, the CAPA Board may request additional information or monitor the circumstances of the event in order to make a decision to escalate an Event or not.

2.5.1 The Board Contact sets the event record at Request More Information state and sends the record back to the Initiator to request more information.

2.5.2 The Board Contact documents the request of additional information and due date for the submittal in the Activity Summary field.

2.5.3 The Board Contact changes to Date Due field in the Event Information tab to the expected date when the Board will meet to re-assess the event.

2.5.4 The CAPA Start Date shall not be set until the Board reviews the event after the requested information has been provided.

2.5.5 In case the event needs to be monitored,

If Then




If Then

The Event record does not yet meet the quality escalation criteria and the CAPA Board requests additional monitoring,

• The Board Contact moves the record to Monitor state.

• Creates instructions for Monitoring on the Board Assessment tab in GCAPA.

• The instructions must include:

A rationale for the monitoring period

Intended information that will help make a decision on whether to escalate the Event to CAPA

Frequency and duration of the monitoring period

Monitoring criteria

• Change Event Date Due to be aligned with the period designated for monitoring.

NOTE: The CAPA Start Date must not be set until the Event is reviewed by the CAPA Board after the monitoring is complete.

2.5.6 When the monitoring period ends or when the requested information is gathered, the CAPA Board must re-assess the event in a CAPA Board meeting and make the decision to escalate to CAPA or not. To allow this re-assess the Board Contact will change the due date to the next CAPA board meeting.




2.6 Once the CAPA Board decides to escalate an Event to a CAPA, the CAPA level is determined using the criteria established in the following table:

When … Then CAPA? is …

• Quality Issue does not meet condition for Global or Business Sector CAPA

Local-Non CAPA

• Issue impacts product in the field AND only one Business Sector reliability risk analysis (FPI Triage, HHA or HHE) is required

• Issue related to 483 delivered by FDA or a major nonconformance issued by a 3rd party agency

• Informal concerns/issues raised by external regulatory or inspection agency, which is deemed as systemic by the Quality organization

Business Sector

• Issue impacts product in the field AND more than one Business Unit product requiring multiple reliability risk analysis (FPI Triage, HHA, or HHE)

• A systemic failure impacting more than one Business Unit

Global




2.7 The compliance risk may be determined using the guidelines in the following table:

When … Compliance Risk

• System breakdown that could be the basis of regulatory action, a threat to the business license or quality system certification.

• Failure to implement and maintain required regulatory or quality management system elements.

• Packaging/labeling error, such as incorrect product in package or incorrect device operation information on label.

• A recurring event with a medium risk priority.

High

• A pattern or trend of deficiencies in a given activity or against a given element of the Quality System.

• A portion of a regulatory requirement not addressed or not being followed in daily operations.

• A result of a process not being followed that impact the fundamental intent of the quality system element.

• A recurring event with a low risk priority.

Medium

• Isolated deficiency related to the quality system that does not compromise the fundamental intent, implementation or effectiveness of the system.

Low

2.8 The following matrix sets the CAPA Priority, based on these following combinations:

If these GCAPA values are… Then enter…

Product in Field? Patient Safety Risk Compliance Risk CAPA Priority Yes Not assessed Any value High Yes High Any value High Yes Medium High High Yes Medium Medium Medium Yes Medium Low Medium Yes Low High High Yes Low Medium Medium Yes Low Low Low No Not Applicable High High No Not Applicable Medium Medium No Not Applicable Low Low




2.9 The next table shows some examples of how to document the risk priority rationale in GCAPA:

CAPA Priority Risk Priority Rationale Example Priority is high because there is product in the field and patient impact has not yet been determined. Field Product Issue Triage, or Field Product Impact Report or HHA/HHE confirmed the issue as high priority.

High

Issue related to a 483 / warning letter delivered by the FDA or a major nonconformance issued by a 3rd party regulatory agency, e.g. TÜV, PMDA, etc. Field Product Issue Triage or Field Product Impact Report or HHA/HHE identified the issue as medium priority. Failure to address a nonconformance could result in a warning letter/483 or revocation of the authorization to market/export product. Issue affects labeling, but does not affect product in the field. Issue is based on internal systemic issue.

Medium

Product/process improvement (preventive action) is identified. Field Product Issue Triage or Field Product Impact Report or HHA/HHE identified the issue as low priority Issue relates to a minor nonconformance issued by a 3rd party regulatory agency, e.g. TÜV, PMDA, etc. Issue will cause a near-term supply chain stoppage. Customer friendliness issues.

Low

Issue will cause a product release delay.

2.10 The CAPA priority shall be re-assessed and/or updated as needed when the following situations are presented:

2.10.1 CAPA Board decides that an event or more than one event will be Closed with Justification are linked to an open CAPA.

2.10.2 Multiple non-conformances issued by a 3rd party regulatory agency, any quality record or risk assessment are referring to an open CAPA. This decision shall be made by the CAPA Board.

2.10.3 The Field Product Issue Impact Report or HHA/HHE or Field Product Issue Triage is updated.

2.10.4 The CAPA scope changed during the investigation phase and the risk associated to it also changed.

2.11 The Board Contact will document the decision of the CAPA Board in the CAPA Risk Priority Rationale field located on the Board Assessment tab.

2.12 The Board Contact reviews the record using the Board Assessment Checklist contained in the MPR-CPA-JTS-009014, CAPA Phase Review Checklists.




2.13 The Board Contact verifies that the Date Confirmed is the one that the Initiator determined when the issue met the criteria to escalate for consideration to CAPA.

If Then

There is affected product in the field, • The Board Contact verifies the status of the Field Product Impact Assessment.

• If an interim report is required, document the report in the record and update the due date to allow for completion of the assessment.

2.14 Events that meet escalation criteria for CAPA must be investigated using the Root Cause with Investigation Task decision in GCAPA. The intent of using this path in GCAPA is to create the necessary tasks to manage risk, understand the problem and determine root cause and to simplify the phase documentation process.

2.15 The CAPA Board must identify the CAPA Owner (Assigned To field) for the event and the Board Contact.

2.16 The Board Contact moves the Event record to Investigation in Progress, changes the parent record Date Due using the following table:

If the Event Then Date Due Minimum

High • 30 days

Medium and Low • Depending on the nature and scope, the CAPA Board may approve additional time for investigation without extension.




2.17 The Board Contact assigns the CAPA Owner the task described on the following table:

Task Title Task Description Due Date Maximum

Duration from CAPA Start Date (calendar days)

Investigation Plan • Define Investigation team – team of people who will investigate the non-conformance.

• Define actions required to perform the investigation – steps or tasks necessary to investigate the non-conformance.

7*

*The seven (7) days allotted for the investigation plan development are included in the total duration of the Investigation phase. The Board Contact is required to change the record Date Due accordingly.

2.18 For Neuromodulation Business Unit: When CAPA priority is High and/or there is product in the field, Quality Manager need to notify the BU to determine further actions. The CAPA Owner and/or Board Contact need to notify to the respective BU and present each phase results for approval when required.

3.0 Investigation Phase

The goal of the Investigation phase is to perform an analysis to determine the root cause and to manage the risk of the event. During the investigation, the information collected may clarify the magnitude of the event. If so, the initial magnitude may change while the investigation is taking place requiring a change in CAPA level or priority. The decision and rationale for the decision to change priority and/or CAPA level shall be documented.

During the Investigation phase, the CAPA Owner is responsible for managing the CAPA activities needed to determine root cause and manage risk. The CAPA Owner shall also ensure Investigation results are documented in the CAPA record.

3.1 Investigation in Progress - This is the state of the Event record that requires tasks to be created and completed.




3.2 As a minimum, the CAPA Owner must comply with the information contained in MPR-CPA-JTS-009005, Investigation and Root Cause Analysis Summary in order to conduct and document the investigation. The completed form must be attached as a supporting document to the Investigation tab once the investigation is finished.

3.3 The CAPA Owner is responsible for reviewing the mitigation activities performed and documented in the CAPA record to determine if an update is needed. Ensure that the link to an approved Field Action and Product Hold identifiers (if applicable) are tracked in the Mitigation Grid on the Event Information tab.

Note: if no PHO or Field Action was issued justification shall be documented in the mitigation field.

3.4 The CAPA Owner performs a retrospective review based on the event to be investigated. In certain cases where the CAPA is related to a Quality System element a retrospective review should be performed and it should go back a rolling year (as a minimum) and look for other possible problems that may need to be addressed or remediated. In addition, the CAPA Owner should also use the related events report performed by the Board Contact as a reference. The results of the retrospective review should be documented in the record.

3.5 The CAPA Owner may create additional tasks to help manage risk, understand the problem, and determine root cause. Reference to the containment activities must be documented in the Mitigation section of the Event record.

3.6 The CAPA Owner submits the Investigation Plan to the Board Contact for review and approval.

If Then

The Board Contact determines that the Investigation plan needs corrections and more information is required,

• The Board Contact rejects the task, documents the reason for the rejection in the Activity Summary field and adds seven (7) days the record’s Date Due to allow for the CAPA Owner to implement the changes.

• The CAPA Owner provides the required information and re-submits for review and approval.

3.7 The CAPA Owner creates and assigns the necessary CAPA investigation tasks to the Task Owner based on experience and knowledge of the task to be completed.

3.7.1 The Task Owner completes the task and enters the investigation results on the field of the Investigation Results tab of the Task record. The Investigation




Results content should adequately describe how the results have addressed the task requested. The Task Owner must provide evidence of completion of each task. If any, attachments need to be added to the Investigation record. Refer to Attachment II for Attachment guidelines.

3.7.2 As each investigation task is completed, the CAPA Owner must be notified. The CAPA Owner is responsible to conduct the analysis of all completed tasks and results.

3.8 The task originator or Board Contact approves the completed tasks in the CAPA record. Approval of the task means an agreement with the content in any attached file.

3.9 For those cases where the CAPA Owner is the same as the Task Owner, a Peer Reviewer must be selected as the task approver. The approval by the Peer Reviewer means that the results have addressed the task and that there is adequate evidence of task completion.

3.10 Once all tasks have been approved and have a PR State of Closed – Done, the system automatically changes the Event PR State from Investigation in Progress to Root Cause Analysis.

If Then

The determined Root Cause of the event is a human error,

• The CAPA Owner should complete MPR-CPA-JTS-009015, Human Error Analysis Tool.

3.11 The CAPA owner will include the investigation report (MPR-CPA-JTS-009005) and the supporting evidence in an Attachment task type (this attachment will be opened until the critical review activities are close done). When all Investigation tasks have been completed, the CAPA Owner is responsible for summarizing the work completed during the Investigation. This is done by filling out the Investigation Summary, Root Cause Method & Analysis and the Root Cause Grid fields.

3.11.1 Investigation Summary field - Among other information the content must include the following:

• Clarification of the problem – Consider the following questions:

– What is the problem?

– When did it happen?

– How did it happen?

– Where did it happen?

– How was discovered?

– What should have happened? Include the process/procedures step where the event occurred. Specify the process/procedure/system that was not followed.




– Who/what was involved?

• Include a justification for the scope. As guidance always ask:

– What is the bounding for the involved product and the criteria used to establish it?

– Why the other areas or products are not impacted?

– Why the other businesses are not impacted?

• What was the disposition of the affected product (if applicable)?

• What information was gathered, reviewed and/or evaluated.

• Results of the reviews/evaluations of the information.

• Results of the risk assessment performed by the Business Unit in cases where there is affected product in the field.

• Rationale for extended durations to the Investigation phase (if applicable).

3.11.2 Root Cause Method & Analysis field must include:

• Root cause methodology used

• Analysis of the data collected by the investigation tools, i.e., Pareto, distribution analysis, scatter diagrams, histograms, capability analysis and gauge R&R.

• Summary of root cause findings (in alignment with the Root Cause grid)

• Conclusion of each cause evaluated

• A rationale that includes enough evidence to justify when a root cause could not be confirmed.

3.12 When documenting the Root Cause Analysis and based on the information documented in the Event record, the CAPA Owner must consider the questions used by the CAPA Board during the critical review (see below).

3.13 The CAPA Owner reviews and updates any entries required in the Product Affected Grid, Product in Field, Material Affected Grid and/or Process Affected Grid (if applicable). Once the Event is moved past the Investigation Phase, the grids can no longer be updated, unless the Event is moved into Correction state by a GCAPA Coordinator.

3.14 If the Event was marked for Product in Field = Yes, then the Field Product Impact documentation must be a final document or rationale for no Impact Assessment should be complete before the Investigation phase can be concluded.

3.15 Once the task of the Field Product Impact Assessment is complete, the Board Contact or a BU representative shall review and update the CAPA Risk Information to be aligned with the approved document:

• Priority

• Risk Priority Rationale – identifies the procedure or document that was used to set the priority and risk values.




• Patient Safety Risk – high, medium or low based on the Field Product Impact. This field will be blank if there is no product in the field.

• Compliance Risk – high, medium or low based on the Field Product Impact or process assessment of the actual or potential nonconformance.

• Patient Severity – the hazard and health consequences from the Field Product Impact issue category matrix. This field will be blank if there is no product in the field.

• Rate of Occurrence – the probability/rate of occurrence from the Field Product Impact issue category matrix. This field will be blank if there is no product in the field.

• Predicted Product Failures – derived from the Field Product Impact and will be blank if no report is completed.

• Predicted Injuries – derived from the Field Product Impact and will be blank if no FPIR is complete.

3.16 The Board Contact also reviews and updates the Mitigation information in the event record:

• Initial Containment Date with the earliest Product Hold Order approval date, if applicable. This field will be blank if there if no PHO is required.

• FCA Determination Date - When the Field Product Impact has been approved with an FCA recommendation, update the FCA Determination Date field with the approval date. This field is not required if there is no product in the field.

3.17 The CAPA Owner notifies the Board Contact when the Root Cause Method & Analysis is complete and ready to be reviewed.

3.18 The Root Cause Analysis review is documented through an Investigation type task defined as Critical Review. The Board Contact opens and assigns two Critical Review tasks, one to a Quality/Compliance Manager and the other to the Affected Area Manager.

3.19 The critical review is to determine if the investigation is complete and adequate.

3.20 The critical review must be completed within a 7-day period after the Root Cause Analysis has been reviewed by the CAPA Board.

3.21 The questions specified below must be answered for the Critical Review by the Board Member:

• Was the problem scope appropriate and rationale provided?

• Is there a distinction between primary and contributing causes?

• If appropriate, were detection methods reviewed to determine if they permitted an escape of the issue?

• Are the root cause analysis methods used appropriate for the type of problem?

• If root cause could not be confirmed, is there compelling evidence for completing this phase based on the information in the record?




3.22 The questions specified below must be answered for the Critical Review by the Affected Area Manager:

• Is the root-cause analysis conclusion substantiated by data? Are these cause and effect inferences legitimate and unbiased? In the absence of data, is there a rationale for the conclusion?

• If the CAPA has a technical cause, has the CAPA Owner considered if there is also a process root cause?

• Were the appropriate subject matter experts involved in determining or reviewing the root cause and supporting work?

• If appropriate, were detection methods reviewed to determine if they permitted an escape of the issue?

3.23 The Critical Reviewer documents the results of the review on the Investigation Results tab of the task record. Note any deficiencies with a description of the issue, or provide a statement that the questions have been fulfilled.

3.24 The Critical Reviewer is responsible for working with the CAPA Owner to solve the identified deficiencies within the record.

If Then

The Critical Review identifies that the Investigation needs corrections and more information is required,

• Notifies the CAPA Owner.

• The Board Contact ensures that the Event is in the state necessary for the CAPA Owner to make the necessary changes.

• CAPA Owner makes necessary changes to the Event record.

• Once all Critical Review deficiencies have been corrected, the Critical Reviewer will promote the task for review, by choosing Complete from the Activity/Activity Type dropdown.

3.25 The Board Contact reviews the results of the Critical Review task to ensure:

• An adequate response exists for each request or question.

• All deficiencies noted have been fulfilled. If not, rejects the task. When this happens, the Board Contact will change the Event Date Due to allow for seven (7) days for the Critical Reviewer to implement the changes to the record and re-submit.

3.26 The Board Contact approves the Critical Review task when the record is deemed complete and adequate.




The signature at this process step means: The Critical Review was completed and each request and question was successfully answered with no remaining deficiencies.

3.27 During the period of the critical review and prior to the approval, the Board Contact assesses the record completeness and adequacy using the Root Cause checklist contained in MPR-CPA-JTS-009014, CAPA Phase Review Checklists.

3.28 Once the Investigation results are reviewed by the Board Contact, the CAPA Owner promotes the record to the state of Analysis Complete.




If Then

• The CAPA Owner changes the CAPA record status to Analysis Complete.

CAPA Contact approves the Investigation and Root Cause Analysis and the Event record is complete and accurate,

• Saves the record in Post Any Activity/Activity Type of Root Cause Review Complete. This action will lock the fields on the Event Information and Investigation tabs (except for the Mitigation fields, which remain editable as long as the record is not closed).

• Approves Root Cause Analysis. • GCAPA automatically promotes the record

to Action Plan. NOTE: This action triggers a notification to the CAPA Owner that the record has changed state.

Board Contact determines Root Cause Analysis record needs corrections or insufficient and more Investigation tasks are required,

• The Board Contact rejects the Root Cause Analysis and changes the Date Due adding seven (7) days to allow for correction and approval.

• The CAPA Owner corrects the record and re-submits the Root Cause Analysis for approval.

3.29 When a root cause analysis is rejected by the CAPA Board and it takes more than seven (7) days to correct the record or further investigation is required, an extension must be requested by the CAPA Owner.

3.30 If a change needs to be made to an approved Date Due in the Investigation phase, approval needs to be obtained for the change, refer to Section 7.0, Escalation and Extensions.

A signature at this process step means: Root Cause analysis is sufficient, the attachments (if any) support the root cause conclusions and the risk and product affected data are accurate based on the attachments. This signature must be performed by someone with the responsibility to make this assessment and the individual signing as Board Contact has completed the CAPA Checklist to ensure conformity with CAPA and quality record processes.




4.0 Action Phase

The CAPA Owner develops a comprehensive set of corrective and/or preventive actions to address the root cause of the potential or existing nonconformance and avoid occurrence or recurrence of the problem. Provide a detailed Action Plan to implement the corrective and/or preventive action as needed.

4.1 The CAPA Owner has 20 days to develop an Action Plan strategy after the Root Cause Analysis has been approved. As a recommendation, the CAPA Owner should present the Action plan for the CAPA Board’s review before the allowed time ends in order to implement any feedback and to obtain approval.

4.2 The Board Contact creates an Investigation type task under the Action Plan state and updates the record Date Due to allow 20 days for the development of the plan.

4.3 The Action Plan must be approved within a 7-day period after the Action Plan is developed and submitted. The Board Contact changes the Date Due in the Investigation type task to 7 additional days for the Action Plan approval.

4.4 The CAPA Owner must set the Event Date Due in GCAPA to allow for the duration of the Action plan implementation.

If Then

Action plan is required, the CAPA Owner

• Decides if the Action plan requires planned tasks or not.




If Then

The actions were taken during the Investigation phase and no further activities are required,

The CAPA Owner:

• Documents a rationale for the decision in the Action Plan Summary GCAPA field.

• Documents results of actions taken during the investigation phase in the Action Result Summary GCAPA field.

• Presents to the CAPA Board for review.

• The CAPA Owner selects Action Plan without Planned Tasks. This will move the record to next state Action Execution in Progress - No Tasks.

• Submits the record for the CAPA Board approval according to Attachment I, Minimum Approvers Matrix.

The Board Contact:

• In the Activity Type field, selects No Action Task to promote the record to Effectiveness Plan.

4.5 As guidance for CAPAs where actions were taken during the Investigation phase and no further activities are required, the CAPA Board should consider the following questions during the review of the CAPA Owner Action Plan Summary:

• Is there objective evidence or rationale provided which supports the justification in the Action Plan Summary?

• Are there any corrective actions that address root-cause, outside of this CAPA (or another referenced CAPA)? If so, is it justified that the CAPA be closed with no action?

4.6 The CAPA Owner develops the Action plan, with or without planned tasks.

If Then

The Action plan is without planned tasks,

• Documents a rationale for the decision and a description of the action plan in the Action Plan Summary field.




If Then • Saves the record.


• The CAPA Owner selects Action Plan without Planned Tasks.

• Schedules the Event record for Action Plan Approval according to Attachment I, Minimum Approvers Matrix.

• The CAPA Board reviews the Action Plan Summary.

• If the Action Plan Summary needs corrections, the Board Contact rejects the record and changes the Event Due Date to allow seven (7) days for the CAPA Owner to make the changes to the record and re-route for approval. NOTE: The Board Contact will ensure that the Event is in the state necessary for the CAPA Owner to make changes.

• This only applies to the CRDM Business Unit: If there is affected product in the field and 30 days has passed since the last update to the Field Product Impact documentation, a Field Performance Review Investigate task must be completed prior to submitting the Event for Action Plan Approval.

• Plan is submitted for approval.

• After approval, in the Activity Type field, the Board Contact selects No Action Task to promote the record to Effectiveness Plan.

4.7 The following list provides guidance for the CAPA Owner when preparing action tasks:

• Define clear, unbiased supporting evidence or rationale to explain how the actions will prevent recurrence/occurrence of the root cause.




• If the solution (set of actions) is not immediate, define interim short term actions if possible. If not, include evidence that they have been assessed.

• Define and plan verifications or validations to ensure that proposed changes result in the desired outcome and that does not adversely affect the finished device.

• If needed, consider the implementation of monitoring and/or detection that would prevent recurrence of the issue from escaping.

• If the solution does not completely eliminate the issue and prevent recurrence, confirm alignment with the proper stakeholders with the current solution.

• Are the corrective actions broad enough to address the root cause? What risks may arise if the planned actions are taken?

• As part of the developing the set of actions, use the duration guidelines as a baseline or reference to assign the due date. Duration guidelines are established by action category; refer to Attachment III, in Estimated Action Task Duration Guideline.

4.8 The following tasks are required in case they apply:

• Does the FMEA need revision? If so, is there a task to review the FMEA?

• If there are periods between actions that are greater than 30 days, tasks need to be created in order to show record progress.

If Then

The Action plan is with planned tasks, • The CAPA Owner creates child Action tasks in GCAPA for the proposed activities, assigns owner and task approver.


• The CAPA Owner Selects Action plan with planned tasks.

• Schedules the Event record for Action Plan Approval according to Attachment I, Minimum Approvers Matrix.




If Then

• The CAPA Board reviews the Action Plan Summary.

• CAPA Board determines that the Action Plan needs corrections, the Board Contact rejects the record and changes the Event Due Date to allow seven (7) days for the CAPA Owner to make the changes to the record and re-route for approval. NOTE: The Board Contact will ensure that the Event is in the state necessary for the CAPA Owner to make changes.

• Plan is approved according to scheduled approvers selected by the CAPA Owner.

• GCAPA promotes the record automatically to Action Execution in Progress and the tasks to Work in Progress.

4.9 In evaluating the action plan submitted by the CAPA Owner, the CAPA Board should use the same set of guidelines stated above.

4.10 The Board Contact reviews the Action plan record using the Action Plan Checklist contained in the MPR-CPA-JTS-009014, CAPA Phase Review Checklists.

4.11 Once the Action Plan is approved, GCAPA notifies the Task Owner to start the execution of the action tasks.

A signature at this process step means: The Action Plan Summary and action tasks are adequate to address root cause and are supported by resources to accomplish the tasks as indicated by the due dates. This signature must be performed by someone with the responsibility to make this assessment and/or commit the resources and the individual signing as Board Contact has completed the CAPA Checklist to ensure conformity with CAPA and quality record processes.

4.11.1 The Task Owner enters the action results on the Action Results tab of the Task record. The action results content should adequately describe how the results have addressed the requested task. The Task Owner provides evidence of completion of each task.




4.11.2 The Task Owner submits the task for approval. TrackWise sends a notification to the CAPA Owner. The CAPA Owner is responsible to conduct analysis of all completed tasks and results.

4.11.3 If the CAPA owner is not the Task Originator, the CAPA owner must ensure that the Task Originator is notified of the need to approve a task.

4.11.4 For those cases where the CAPA Owner is the same as the Task Owner, a Peer Reviewer must be selected as the task approver. The approval by the Peer Reviewer means that the results have addressed the task and that there is adequate evidence of task completion.

4.12 If a change needs to be made to an approved Date Due in Action phase, approval needs to be obtained for the change, refer to Section 7.0, Escalation and Extensions.

4.13 In case a deviation from an approved action plan is warranted, re-planning and approval is required.

4.14 Once all tasks have been approved and have a PR State of Closed – Done, the Event will automatically be changed to the PR State of Effectiveness Plan.

5.0 Effectiveness Phase

The Effectiveness phase is the process to establish that corrective and preventive actions were effective and accomplished the intended objective.

5.1 Once the record state is in the Effectiveness Plan state, the CAPA Owner creates an Investigation type task to document the Effectiveness plan, assigns the Board Contact as approver and updates the record Date Due to allow 10 days for the task completion.

5.2 During this 10-day period, the CAPA Owner documents the action phase results in the Action Results Summary field and generates the Effectiveness plan and presents it to the CAPA Board for review.

5.3 When developing the plan, the CAPA Owner changes the Event Date Due in GCAPA to allow for the duration of the Effectiveness monitoring period and for documenting the Effectiveness Results Summary.

5.4 As a recommendation, the CAPA Owner should present the Action Results Summary to the CAPA Board before the effectiveness planning period ends in order to implement CAPA Board’s feedback (if any) and for approval.




5.5 The process for verifying that the corrective actions taken are effective and are unlikely to recur requires proactive assessment to confirm that the actions were successful in addressing the cause of problem.

5.6 Evidence that the cause of the problem have been removed or reduced should be provided (i.e., verification of improved processes, data of monitoring activities, etc.).

5.7 Recommended steps for the creation of the Effectiveness tasks are:

• What will be measured

• Duration of the measurement

• Frequency of measurement

• Person who will perform the task - must be assigned to a Quality representative.

• Closure criteria

5.8 The CAPA Owner can use Attachment IV – Effectiveness Plan Guide to develop the Effectiveness Plan.

5.9 As a guidance in the creation of the Effectiveness tasks consider the following monitoring time periods:

If Minimum Recommended Monitoring Period

Activity occurs every shift or daily 14 days

Activity occurs weekly 70 days

Activity occurs monthly 180 days

Activity is executed through a simulation

60 days

Activity does not takes place regularly

Consult a Compliance representative or designee to determine an appropriate monitoring period

5.10 For effectiveness periods longer than 70 days, a status report is required every month from that point on.

5.11 Evaluation conducted during the monitoring period shall demonstrate effectiveness by simulation exercises or the complete and definitive proof that actions sought, address each identified root cause.

5.12 For CRDM CAPAs only: If there is affected product in field, the CAPA Owner must include a task for a Final Field Performance Review.




If Then

• The CAPA Owner documents the Effectiveness Plan Summary.

• Presents to the CAPA Board for review

• The CAPA Owner selects Effectiveness w/o tasks and Yes in the Effectiveness Required field.

• Submits the Effectiveness Plan for approval according to Attachment I, Minimum Approvers Matrix.

• Selects Effectiveness Plan Defined in the Post Any Activity section of GCAPA. The record moves automatically to Effectiveness Plan Approval State.

Effectiveness plan is without planned tasks,

• The CAPA Board reviews the Effectiveness Plan Summary.

• If deficiencies are identified, the Board Contact rejects the record and changes the Event Due Date to allow seven (7) days for the CAPA Owner to make the changes to the record and re-route for approval. NOTE: The Board Contact will ensure that the Event is in the state necessary for the CAPA Owner to make changes.


• GCAPA promotes the Event record to Effectiveness Results Summary.




If Then

• The CAPA Owner creates child Effectiveness tasks in GCAPA for the proposed activities, assigned owner and task approver.

• Presents the plan to the CAPA Board for review.

• The CAPA Owner selects Effectiveness with tasks and Yes in the Effectiveness Required field.

• Submits the Effectiveness Plan for approval according to Attachment I, Minimum Approvers Matrix.

• Selects Effectiveness Plan Defined in the Post Any Activity section of GCAPA. The record moves automatically to Effectiveness Plan Approval State.

Effectiveness plan is with planned tasks,

• The CAPA Board reviews the Effectiveness Plan Summary.

• If deficiencies are identified, the Board Contact rejects the record and changes the Event Due Date to allow seven (7) days for the CAPA Owner to make the changes to the record and re-route for approval. NOTE: The Board Contact will ensure that the Event is in the state necessary for the CAPA Owner to make changes.


• GCAPA promotes the Event record automatically to Effectiveness Execution in Progress and the tasks to Work in Progress.




5.13 The Board Contact reviews the Effectiveness plan record using the Effectiveness Plan Checklist contained in the MPR-CPA-JTS-009014, CAPA Phase Review Checklists.

A signature at this process step means: The Action Plan Results and Effectiveness Plan Summary are adequate to provide evidence that the actions addressed the root cause and that the effectiveness phase is supported by the appropriate resources. This signature must be performed by someone with the responsibility to make this assessment and/or commit the resources and the individual signing as Board Contact has completed the CAPA Checklist to ensure conformity with CAPA and quality record processes.

If Then

Effectiveness plan with planned tasks is approved,

• The Task Owner starts executing the Effectiveness tasks

• When the tasks are complete, the Task Owner summarizes and documents the results and submits them for approval.

Effectiveness plan is without planned tasks is approved,

• The CAPA Owner documents the phase results in the Effectiveness Results Summary in the GCAPA record and presents it to the CAPA Board for review after the last Action task is complete.

5.14 If a change needs to be made to an approved Date Due in the Effectiveness phase, approval needs to be obtained for the change, refer to Section 7.0, Escalation and Extensions.

5.15 In case a deviation from an approved effectiveness plan is warranted, re-planning and approval is required.

5.16 When the Effectiveness ends, the CAPA Owner documents the phase results in the Effectiveness Results Summary in the GCAPA record after the last effectiveness task is complete.

5.17 The CAPA Owner determines if the CAPA is effective or ineffective in the Effectiveness Decision field. Notify the Board Contact to change Event Date Due.

5.18 Board Contact changes the Event Date Due in GCAPA to allow for the duration of a 15-day period for the closure of the record.

5.19 Then CAPA Owner selects Effectiveness Summary Complete to promote the record to Closure Approval.




If Then

CAPA is effective • CAPA Owner submits record for CAPA Closure.

CAPA is ineffective • TrackWise creates a new record once the decision is approved by the CAPA Board and the event record status is Closed-Done. New record is linked to the ineffective record.

6.0 Closure

The Closure phase of a CAPA formalizes the review of the CAPA record to assure that requirements were met, the conclusion of effectiveness is made and documentation is complete.

6.1 CAPA Board confirms the selection of Effective Decision as Effective or Ineffective.

6.2 Once the Effectiveness Summary Complete decision has been saved by the CAPA Owner, the event is promoted to Closure Approval state.

6.3 The system automatically schedules the Board Contact for approval.

6.4 Before completing Closure Approval, the Board Contact reviews the record using the CAPA Closure Checklist in MPR-CPA-JTS-009014 CAPA Phase Review Checklists.




If Then

CAPA record passes the checklist, • Board Contact approves the event for closure.

If review identifies items that need correction and/or completion in the Event record,

• The Board Contact communicates the deficiencies to the CAPA Owner and changes the event’s Date Due to allow for 10 days for the correction and approval. Six (6) days are allotted for the correction of the record and four (4) for the re-approval.

• Ensures that the Event is rejected in the state necessary for the CAPA Owner to make the changes.

• The CAPA Owner makes the corrections and re-submits for approval.

6.5 In case that the corrections needed to the record cannot be performed in the 10-day allotted period, a rationale of why the closure needs to be extended is required.

6.6 Once the Effectiveness Summary Complete decision has been saved, the system automatically schedules the Board Contact for approval and the CAPA Owner for scheduling of the Event for Closure Approval 1.

6.7 The additional approver approves the record.

The signature at this process step means: The evidence collected during effectiveness phase supports the owner’s conclusion of effectiveness of the actions to address root cause and the CAPA record is adequate. This signature must be performed by someone with the responsibility to make this assessment.




7.0 Escalation and Extensions 7.1 Once an Event is assigned to the CAPA Owner, email notifications are automatically

generated by TrackWise when the record will become due. The notifications are:

• Seven (7) days before the date due • Three (3) days before the date due • Same day the record becomes due

7.2 E-mail notifications on items that are due, are sent to the CAPA Owner and his/her direct Manager. Event items that are due are also discussed during the CAPA Board meetings. Notifications are generated as follows:

• One (1) day after the date due

• Three (3) days after the date due • Seven (7) days after the date due

7.3 If an approved date due needs to be changed in the Investigation, Action or Effectiveness phase, the CAPA Owner must request approval by means of an extension.

7.4 If a task within a phase becomes due, but does not affect the overall record due date, a statement providing status is required in the task.

7.5 A maximum of three (3) extensions may be granted during the CAPA lifecycle.

7.6 The Extension Request Form, MPR-CPA-FRM-009017, needs to be completed for this purpose.

7.7 Once the form is approved, the Board Contact modifies the Event record in GCAPA with the requested changes.

7.8 When extensions are not approved, the CAPA will be deemed overdue and will be reviewed and tracked in the CAPA Board meetings.

7.9 The approved Extension Request Form has to be attached to the Event record as evidence.

7.10 The following examples are considered as acceptable extension rationales:

• A task assigned to an external resource to MPROC

• All tasks are on schedule, but a scope change not known at the time of planning is needed.

• Resources are re-allocated to an issue of higher priority

• An unanticipated significant loss or turnover of key personnel directly associated to the action

• A severe natural catastrophe occurred




8.0 Training 8.1 Quality, Compliance, Engineering, and Manufacturing personnel require explanation of

this procedure and changes.

8.2 CAPA Owners are responsible to complete the certification before performing the role.

F. Change History

Revision Summary of Changes Effective Date

1.X Initial release 28 AUG 11

Modified scope of procedure.

Deleted MPR-QSM-PP-009010, MPROC Complaints Handling Procedure.

Clarified definition of Technical cause.

Added content to the CAPA Coordinator responsibilities. Added content to the CAPA Board Member responsibilities.

Added requirement of bounding activities in case of a repeat event. This is a change required by IKM. Added duration requirement to complete the Rationale for Closure task for an event with a CAPA Board decision of Closed-Justify. Deleted approval meaning since no approval occurs at that point.

Clarified tasks of the investigation plan.

2.X

Added content to the requirement of retrospective reviews in cases for event of Quality System non-conformances. Changed the responsibility of the review of the Investigation plan from CAPA Board to Board Contact. Rephrased sentence to add Board Contact as approver of tasks in Investigation phase. Changed from Patient Harm Probability to Rate of Occurrence to match with TrackWise. Added questions to help the CAPA Owner document the Investigation Summary and Root Cause Method & Analysis.

20 APR 12




Changed task assignment from Board Member to Quality/Compliance Manager. Specified the period for the Critical Review task completion and for its review and approval. Step 3.26 – removed first and last bullet from table. Changed the approver for the Investigation/ Root Cause from the CAPA Board to the Board Contact. Deleted first three bullets from table in step 3.28. When updating the date due, the CAPA Owner only should allow time for the implementation of the actions tasks. Added bullet #3 and changed the order of instructions in the If/Then table. Correction in bullet #2 from Effectiveness plan to Action plan. Deleted bullet #5 from second If/Then table. Deleted Step 4.14`` Modified instructions to change responsible for the creation of a task to develop the Effectiveness plan from the Board Contact to CAPA Owner. Added instruction that establishes the deliverables to be completed during the 10-day period of the Effectiveness plan. Eliminated the requirement to add 15 days for the CAPA closure. Added a requirement for CRDM only for the inclusion of a task that requires a Final Field Performance Review (when applicable).

Removed the CAPA Owner from adding the extension request the record.

Includes Bounding definition in Section B.

Add certification requirements for CAPA Board Member, Owner and Coordinator in Section D.

3X

Add in Section 2.0: • These fields/tasks must be closed before select the

Closed with Justification • If Product affected is selected as yes, the Board

Contact reviews the mitigation for the product bounding (why, when and how) and its rationale for that bounding. Also, the product disposition must be documented in the record (when applicable). Reference of PRR or quality hold shall be included (when applicable).

• The Board Contact reviews the record using the Board

21 MAY 12




Assessment Checklist contained in the MPR-CPA-JTS-009014, CAPA Phase Review Checklists.

To add table indicating the Investigation date due depending of the Event.

Section 3.0 • Added the requirement to complete and attach MPR-

CPA-JTS-009005, Investigation and Root Cause Analysis Summary, as supporting documentation to the record.

Modify instruction for Field Product Impact documentation must be final document or rationale for no Impact Assessment.

Add instructions and situations in 2.10 for re-assessment of CAPA Priority.

Add a 2.15 for Neuromodulation and when a CAPA priority is High and/or product in the field.

Modify instructions in instructions in 2.4 to include the Search Related Events and the use of MPR-CPA-JTS-009014 for Closed with Justification.

Add in 4.0 the Instructions to the Board contact to move the Investigation task type for 7 additional days for the approval of Action Plan. Re-order instructions for section 4.0 Action Phase and 5.0 Effectiveness Phase. For clarification purposes, added instructions when Action Plan without Planned Tasks is selected. Correct typographical errors.

Add Attachment IV – Effectiveness Plan Guide

Add in 5.17 Notify the Board Contact to change Event Date Due.

Change in 5.1 Board Contact with CAPA Owner Add in 5.8 The owner can used Attachment IV – Effectiveness Plan Guide to develop the Effectiveness Plan.




Attachment I – Minimum Approvers Matrix

Required Approvals

All CAPAs • Board Contact

• Quality System Manager or Compliance Manager

• Affected Area Manager

Additional approvers will be scheduled according to the applicable input and BU source procedure.




Attachment II – Attachments Guidelines

Documents that reside in an electronic repository do not need to be attached to the record. Make reference with the document title and revision and the location where it resides.

All the attachments, supporting data or reports included as part of the Event record will be identified with the GCAPA PR number and each page will be numbered.

Attachments that require approval by other than the CAPA owner or Board Contact will either include the evidence of approval or reference the system that stores the approval evidence.

If any meeting or training is conducted as part of the investigation; attendance sheet, meeting minutes or training material will be included in the report.

All the scanned files need to be verified for completeness and correctness.

When attachments are created to support the CAPA and do not have a specific process guiding their creation, the approval gates within the GCAPA lifecycle provide the necessary accountability for their inclusion in the record.

• Data collected for the investigation – These documents can be attached as they are completed and will be approved when as part of the process flow of the CAPA record. Prior to that, they will be viewed as work in progress.

Draft versions of documents that require approval shall not be attached to the CAPA record as evidence. If progress toward completion is required to show continuity, a comment may be entered on the task completion notes.

The file format for attachments shall be portable (PDF) to ensure the content is accessible to all users. If the GCAPA system is the only repository where the file will be stored, include both the native (the file in the original and editable format) and portable versions as part of the attachment. Any file that requires a specialized program to run or view should also be accompanied by a file that has the same content in a portable (PDF) or other common use format.

Documents attached in GCAPA should not include embedded documents. These documents are not universally accessible to all users. If an exception is made, attach the embedded documents separately within the attachment record to ensure accessibility.

Attachments must be added prior to the submittal of the Event for Board review. Once the Attachment has been Completed (using the Post Any Activity/Activity Type of Complete), it cannot be changed.




Attachment III – Action Task Estimated Duration Guide

Action Category Description Estimated Duration

(calendar days)

Conduct Meeting Any meeting designed to collect inputs, brainstorm; where no additional actions are established

21

Conduct an assessment Evaluations, testing, data collection; where further actions or a plan may be developed for opening new actions

42

Equipment purchase – off the shelf

Purchase, supplier lead time, shipment and receipt of major equipment

168

Equipment purchase – custom design

Purchase, supplier lead time, shipment and receipt of major equipment

336

Tooling purchase – fixtures, templates, tools, etc.

Purchase, supplier lead time, shipment and receipt

84

Manufacturing process implementation – local approval

Local change (Reliability/Regulatory Affairs approval not required), document revision and routing, conduct training, approval and release of procedures.

28

Manufacturing process implementation – external approval required

Reliability/Regulatory Affairs approval is required, document revision and routing, conduct training, approval and release of procedures.

14

Change which requires a regulatory submission

Timing of approval from required functions. Regulatory Affairs must confirm final completion of approval

*

Validation/Qualification - Characterization process

Testing activities including applicable plan, execution and report

28

Validation/Qualification - Installation


14




Attachment III – Action Task Estimated Duration Guide (Continued)

Action Category Description Estimated Duration

(calendar days)

Validation/Qualification – Operational qualification


21

Validation/Qualification – Performance qualification


28

QS procedure implementation

Revision, document routing, training, approval and release

42

Generate project plan Development of a project plan where new actions are outlined. May fall under any other action category.

14

Software implementation/changes

Includes implementation of software that has never been used at the site, implementation of software used in other areas of the site, upgrades and improvements. Tasks include development, testing and release.

120

Design change implementation

Changes requested through an Engineering Change Order/Engineering Change Request process with the intent of changes to product design specifications

**

*Determined based on feedback from required functions. **Depends on scope of change (controlled through ECO process)




Attachment IV – Effectiveness Plan Guide

Stage What to check for

Preparation Assure that the determined root cause is addressed in the established corrected/ preventive actions.

• If this is not correct, then the root cause investigation process needs to be re-evaluated.

• If this is correct, then you can start defining the effectiveness verification plan.

Assure that all the actions were implemented as defined.

What will be measured Indicate what is going to be measured a particular process, procedure execution, PRR’s, documentation review, etc.

• Assure that is something that can be measured.

• If it cannot be measured, it needs to be excluded from the effectiveness verification.

How it will be measured Assure that a sampling plan is included with the corresponding rationale to justify it.

• Effectiveness verification cannot be conducted without a sampling plan.

How long it will be measured Assure that a period is established for the monitoring process. It needs to be based on the minimum periods in the Work Instruction.

Definition of how it will be reported

Assure that you clearly established how the data of the monitoring process will be taken, measured and how the results will be document to clearly understand the intention of the data and the results obtained.

Effectiveness Criteria Assure that it is clearly established the value, range or acceptance / rejection rationale that will help determine if the implemented corrective /preventive actions were effective in addressing the nonconformance.