Medtronic Controlled Informationlmsgbl.medtronic.com/production/cninv000000000127331/content.pdf · (QMS-SOP) - Global IT Corrective and Preventive Action SOP. 86967-SOP. Medtronic

Medtronic Controlled Information

This document/record is electronically controlled; printed copies are considered uncontrolled.System of Record: Medtronic Records Control System (MRCS)

Identifier Version Author

86967-SOP 14.0 Eickhof, Le Anne

Title:(QMS-SOP) - Global IT Corrective and Preventive Action SOP

Approved Effective

04-Aug-2016 19:41 UTC 04-Aug-2016 19:59 UTC

APPROVALS

Signed by Date/Time (UTC) Meaning of Signature

Eickhof, Le Anne 03-Aug-2016 18:00 Author

Branch, Michael 03-Aug-2016 19:59 Manager

Branch, Michael 03-Aug-2016 20:00 Global IT QA Lead

Moon, Darci 04-Aug-2016 19:41 Quality Group

Global IT Quality Management System Page 1 of 21

Table of Contents

DOCUMENT HISTORY......................................................................................................... 3

OVERVIEW ......................................................................................................................... 3

PURPOSE ............................................................................................................................ 3

SCOPE................................................................................................................................. 4

REFERENCES ...................................................................................................................... 4

TERMS AND DEFINITIONS ................................................................................................. 4

PROCESS OVERVIEW ......................................................................................................... 7

1. CORRECTIONS AND CONTAINMENT ....................................................................... 7

2. CAPA Phases ............................................................................................................ 7

3. CAPA PROCESS INPUTS........................................................................................... 8

3.1. Quality Data Sources ........................................................................................................8

3.2. Data Analysis....................................................................................................................8

4. PROCESS.................................................................................................................. 8

4.1. KEY ROLES WITHIN THE CAPA PROCESS...........................................................................8

4.2. APPROVAL MATRIX...........................................................................................................9

4.3. GOVERNANCE ................................................................................................................10

4.4. ASSESSMENT PHASE ......................................................................................................10

4.4.1. CAPA Request...................................................................................................................... 10

4.4.2. CAPA Request Review.........................................................................................................10

4.4.3. Decision Not to Perform a CAPA Investigation ...................................................................10

4.4.4. Decision to Perform a CAPA Investigation..........................................................................10

4.4.5. Establish CAPA Priority........................................................................................................11

4.4.6. CAPA Scope ......................................................................................................................... 12

4.5. INVESTIGATION PHASE ..................................................................................................13

4.5.1. Document Initial Correction and Containment...................................................................13

4.5.2. Identify Investigation Team ................................................................................................ 13

4.5.3. Investigate and Identify Root Cause ................................................................................... 13

4.5.4. Create Corrective/Preventive Action Plan ..........................................................................13

4.5.5. Create Effectiveness Strategy ............................................................................................. 14

4.5.6. Set the Action Phase Due Date ........................................................................................... 14

4.5.7. Investigation Review...........................................................................................................14

This document/record is electronically controlled; printed copies are considered uncontrolled Confidentiality:

Identifier: Title: Version:

14.0

(QMS-SOP) - Global IT Corrective and Preventive ActionSOP

86967-SOPMedtronic Controlled Information


4.5.8. Approval of Investigation Phase Completion......................................................................14

4.6. ACTION PHASE...............................................................................................................14

4.6.1. Action Execution ................................................................................................................. 14

4.6.2. Verify/Validate .................................................................................................................... 15

4.6.3. Implementation Results......................................................................................................15

4.6.4. Set Effectiveness Phase Due Date....................................................................................... 15

4.6.5. Approval of Action Phase Completion ................................................................................ 15

4.7. EFFECTIVENESS PHASE ..................................................................................................15

4.7.1. Execute & Summarize Effectiveness Results ......................................................................15

4.7.2. Effectiveness Review and Approval/CAPA Closure............................................................. 15

4.8. EXTENSIONS..................................................................................................................16

4.8.1. Extension Request...............................................................................................................16

4.8.2. Extension Request documented in CAPA ...........................................................................16

4.8.3. Required Approvals.............................................................................................................16

4.9. MANAGEMENT REVIEW...................................................................................................16

4.10. TRAINING ......................................................................................................................16

DELIVERABLES................................................................................................................. 17

APPROVALS ...................................................................................................................... 17

APPENDIX A– Root Cause Critical Review ....................................................................... 18

APPENDIX B – CAPA Determination Questions ............................................................... 19

APPENDIX C – TrackWise CAPA PR States and Roles ...................................................... 21



14.0




DOCUMENT HISTORYThe history table shows recent change descriptions. Change descriptions for prior versions are available

in previously retained versions of this document.

Revision Reason/Description14.0 Removed a watermark “Draft” that was on page 14 of the document. No other

changes were made in this revision.

13.0 Updated document throughout to align with the Global CAPA SOP defined by the

Global CAPA Sub Council.

12.0 Added a question to the Root Cause Critical Review regarding the consideration of

business input when determining CAPA risk priority.

11.0 Added the SCAPA process as an output of the Global IT CAPA assessment. As part of

this, the SCAPA SOP and Supplier Management SOP were added to the reference

section. Also aligned the text in the SOP with the Timeline in Appendix B to indicate

business days instead of calendar days for Action Planning, Effectiveness Planning and

CAPA Closure.

10.0 Added objective evidence definition to the “Abbreviations, Acronyms, and Definitions”

section. Added responsibility to CAPA owner to ensure documentation and objective

evidence is complete. Added responsibility to Task Owners to include objective

evidence in CAPA tasks. Added text to “Investigate Cause and Manage Risk”, “Action”

and “Evaluate Effectiveness” sections to include objective evidence. Moved the

“History” section to the front of the document.

11.0 Added section 7.10

OVERVIEW

PURPOSE

The purpose of this procedure is to provide a consistent and effective Corrective Action and Preventive

Action (CAPA) procedure across Global IT and, in so doing, ensure compliance with the CAPA

requirements of the Quality System Regulation and applicable International Standards.



14.0




SCOPEThis procedure applies to Global IT organizations that are governed by the Global IT Quality

Management System and all Medtronic personnel that are involved in work related to Corrective and

Preventive Action (CAPA) for processes, product and/or services related to Global IT.

This procedure details the CAPA procedure for the Global IT Quality Management System. This procedure defines the method to:

assess and investigate product and quality issues (existing and potential)

take appropriate and effective corrective/preventive action to prevent recurrence/occurrence disseminate the information to both those responsible for the quality of the product and to

those conducting management review

REFERENCES

Reference ID Document of External Origin (Y/N)1

Title / Description

030 – Corrective and Preventive Action

N Corrective and Preventive Action Policy (Corporate)

30031560 N Global IT CAPA Governance SOP 87055-P N Global IT Quality Management System Manual92712-SOP N Global IT Management Review SOP30004713 N Global IT SCAPA SOP117427-SOP N Global IT Supplier Management SOPISO 13485:2012 Y Medical Devices Quality Management SystemsFDA 21 CFR Part 820

Y Quality Management System Regulation

70654 N Global Records & Information Management Retention Schedule

034 N Product Risk Management 30026101 N Global IT QMS Management Representative

Appointment Record1 Identification of Document of External Origin (document originates from outside of Medtronic) is required by the Corporate Global Policy 028 Quality Records and Document Control Policy.

TERMS AND DEFINITIONS



14.0




Term Definition

Affected Product Product that has the issue described in the CAPA, whether or not the product is in

the field.

CAPA Decision Result of review of a CAPA Request. A decision can be “yes” or “no”; yes indicates

that the CAPA Request warrants moving forward to the Investigation Phase.

CAPA Board Comprised of cross-functional members and oversees CAPA activity including

ensuring consistency across CAPAs, allocating resources, driving accountability

throughout the organization, ensuring records are complete, and providing

guidance to CAPA responsible people.

Causal Factor The condition (human error, equipment failure, or material failure) that directly

caused the problem, allowed it to occur, or allowed the consequences to be worse.

Containment Immediate actions taken to control the degree of risk of a nonconformance and to

prevent its continuance until a full investigation is complete (e.g. stop processing,

quarantine, and place product on hold).

Correction Action taken to eliminate a detected nonconformance. Examples of corrections are:

rework, sort, correct records, repair equipment, calibrate, re-train, issue Quality

Alert; or implement temporary additional controls, e.g. added inspection.

Corrections are typically one-time fixes, and may be done in concert with a

corrective action if the problem recurs or otherwise persists. (Corrections are also

known as remedial or containment action).

Corrective Action Action taken to eliminate the cause(s) of a detected nonconformance or other

undesirable situation. The corrective action should eliminate the root cause to

prevent the recurrence of the issue.

Corrective Action and

Preventive Action (CAPA)

A term used to describe a process that includes actions needed to correct

(correction), avoid recurrence (corrective action), and eliminate the cause of

potential nonconforming product and other quality problems (“preventive action”).

Data Sources The processes within a Quality Management System that provide quality

information that could be used to identify nonconformities, or potential

nonconformities.

Effectiveness Check Monitoring or assessments completed after implementation of Corrective and/or

Preventive Actions to establish whether actions taken were effective and

accomplished their intended purpose.

Effectiveness Evaluation Documented process to establish that an action was effective and accomplished the

intended objective(s).



14.0




Term Definition

Effectiveness

Measure/Action

Actions (such as monitoring or assessments), taken after implementation or

deployment of corrective and preventive actions to ensure the actions accomplish

their intended purpose.

Event The primary record about an issue that may become a CAPA. It provides an

executive summary and key data about the issue and its progress towards

resolution. This record is parent to task and attachment records.

Mitigation Steps taken to alleviate or lessen an issue, including Corrections and Containment;

these steps are typically required when an issue is first identified but may also be

required throughout the life of a CAPA.

Nonconformance Non-fulfillment of a specified requirement.

Objective Evidence Evidence that establishes results achieved or provides evidence of activities

performed.

Patient Safety Risk A product related risk assessment value derived when evaluating patient risk that is

known or suspected to be affecting clinical or market released products.

Preventive Action Action taken to eliminate the cause of a potential nonconformance, defect, or

other undesirable potential situation. Preventive action should prevent the

occurrence of the potential issue. If the corrective action can be extended to other

products/processes/systems not yet affected by this root cause, then it may be

considered preventive action.

Product in the Field Affected product is beyond a Medtronic-controlled distribution center, or was

retrieved for quality reasons from locations beyond a Medtronic-controlled

distribution center.

Potential Root Causes The chain of causes that result in the root cause(s) including the consideration of

people, method, machine, materials, environment and management system.

Quality Data Sources The processes within a Quality Management System that provide quality

information that could be used to identify nonconformances, or potential

nonconformances.

Risk Analysis The technique used to identify and assess risk factors associated with an event.

Root Cause True reason for the non-conformance and or failure in a process, component or

product. Root causes are the basic reasons for why causal factors occur or persist.

Refer to “Causal Factor” definition.



14.0




Term Definition

Root Cause Analysis The analysis needed to determine the original or true cause of a system or process

problem. This effort extends beyond the effects of a problem to discover its most

fundamental cause. It includes the analysis of multiple data sources to identify

either existing or potential causes of nonconforming product or quality problems. If

appropriate, statistical methodology shall be employed.

SCAPA Supplier Corrective and Preventive Action

Trend A series of events leading to the conclusion that a shift or change from normal

operating levels happened.

PROCESS OVERVIEWThe CAPA process establishes requirements to ensure that identified quality issues (both actual and

potential) are reviewed and actions are taken to prevent their occurrence or reoccurrence.

1. CORRECTIONS AND CONTAINMENTCorrection and containment actions relevant to the quality issue are expected to be performed, as

needed, during CAPA process.

2. CAPA PHASES

Assessment Phase Assesses the CAPA Request and documents the decision whether or not the quality issue

requires a CAPA Investigation. If CAPA Decision is yes, a CAPA Priority is determined.

Investigation Phase Determines the root cause(s) of the quality issue.

Summarizes initial correction and containment actions.

Includes definition of Action Plan and Effectiveness Strategy.



14.0




Action Phase Implements and verifies actions to prevent occurrence/recurrence of the quality issue.

Effectiveness Phase Determines whether or not the actions taken addressed the identified cause(s).

3. CAPA PROCESS INPUTS

3.1. Quality Data SourcesCAPA input sources include, but are not limited to, the various processes that identify or measure the conformance or nonconformance of product, process, and/or quality system requirements (e.g. complaints, nonconforming material, internal/external audits, clinical trials, environmental monitoring, quality records, disaster recovery exercises).

Input source processes may include requirements to define occurrences or trends that require assessment for CAPA. These potential input source data to the CAPA System are established, maintained and monitored outside of this procedure.

Input source procedures that specify triggers for opening a CAPA that use the term “Mandatory CAPA” shall result in a decision to initiate a CAPA as described in 4.4.2. (i.e. an ineffective CAPA, a significant finding by notified body or regulatory agency, or an issue affecting product in the field).

Input source procedures that specify triggers for opening a CAPA that do not use the term “Mandatory CAPA” will be treated as a CAPA Request as described in 4.4.1.

3.2. Data AnalysisInput source data monitoring and analysis shall be conducted to detect single significant occurrences and/or possible trends and determine when to initiate a CAPA Request.

Where specific trend data requirements, intervals of measure, or thresholds for which issues shall be assessed for CAPA have been established, appropriate statistical and/or non-statistical methodologies shall be employed to enable detection and decide when to initiate a CAPA Request.

4. PROCESS

4.1. KEY ROLES WITHIN THE CAPA PROCESSThe CAPA process was established in a manner that ensures that sufficient resources and subject matter expertise are available. The responsibilities for accomplishing this have been distributed among the following roles (one individual may fulfill multiple roles).



14.0




Roles and Responsibilities

Role Responsibilities

CAPA Board ChairHas the authority to approve date extensions or other unusual

circumstances in the CAPA Record.

CAPA Board MemberParticipates in decisions about CAPA execution.

Provides resources to support CAPA execution.

CAPA SpecialistEnsures that the CAPA record complies with this process.

Provides resources to support CAPA execution.

CAPA RequesterRequests that a quality issue be evaluated for CAPA Decision.

Initiates CAPA Request.

CAPA OwnerEnsures all the activities required by the CAPA are completed and

comprehensively documented in the CAPA file.

CAPA Owner’s Manager Provides resources for CAPA ownership.

Should the person appointed to a role be unavailable, tasks assigned to that role may be performed by a designee. The assigning of designees is done in accordance with applicable procedures.

4.2. APPROVAL MATRIX

Approval Matrix

CAPA Phase Event What is Approved Approver*

Assessment CAPA Decision is NORationale for CAPA Request Closure

CAPA ChairCAPA Specialist

Investigation No Actions RequiredRationale for CAPA Closure


InvestigationInvestigation Phase Completion

Root Cause AnalysisAction PlanEffectiveness Strategy


ActionAction Phase Completion

Action ImplementationEffectiveness Plan


EffectivenessEffectiveness Phase Completion

Effectiveness ConclusionCAPA Closure


All Extension Request Rationale

Original phase approval rolesCAPA Chair and CAPA Owners Manager

*Indicates minimum approvers, additional approvers can be added, if needed. Should one person be filling the roles of multiple approvers for a phase, an additional approver shall be added.



14.0




4.3. GOVERNANCE Management with Executive Responsibility is accountable to implement and maintain an

effective CAPA Process.

Global IT’s CAPA governance is documented in the Global IT CAPA Governance SOP.

Global IT Quality Management System CAPA Board’s name is “Global IT”.

The above board shall implement the requirements of this Process and lead the CAPA (orSCAPA) Process efforts as it affects global or functional areas within Global IT.

The CAPA Board will have a CAPA Board Chair that shall be designated as identified in the Global IT QMS Management Representative Appointment Record.

Records of CAPA Board Chair appointments shall be maintained.

4.4. ASSESSMENT PHASE

4.4.1. CAPA RequestThe CAPA Requester shall provide the following information, at minimum:

a scoped problem statement

initial risk assessment

reason for requesting CAPA Assessment

corrections and/or containment performed as a result of detection

completed GLOBAL IT CAPA determination questionnaire (See appendix B).

4.4.2. CAPA Request ReviewThe CAPA Board shall review and determine whether or not the CAPA Request should be moved into Investigation. Except for those requests that are called out by the Quality Data Source as mandatory, the CAPA Board has final discretion on which CAPA requests are progressed into investigation.

The Board should consider the responses to the Global IT CAPA Determination Questionnaire in their decision to investigate.

If the assessment identifies that the source of the issue is supplier related, the board should consider if the issue is a SCAPA. If a SCAPA is indicated, follow the Global IT SCAPA SOP.

The CAPA Board may determine that there is insufficient information to make a decision and can ask the CAPA Requester to provide more information; the Requester and CAPA Specialist will agree on a timeframe for re-review of the CAPA Request.

The full extent of a problem need not be determined in order for a CAPA decision to be made.

4.4.3. Decision Not to Perform a CAPA InvestigationIf the decision is to not move a CAPA Request into Investigation, the rationale shall be documented by the CAPA Specialist and approved by CAPA Board Chair, at a minimum; the CAPA Requester shall be notified of the decision.

4.4.4. Decision to Perform a CAPA InvestigationIf the decision is to initiate a CAPA Record, the CAPA record shall include the following information, at a minimum:

Problem Statement

CAPA Owner



14.0




CAPA Specialist

The Investigation Phase Due Date shall be established commensurate with risk.

The Investigation Phase Due Date should consider the guidelines below along with risk.

The following have been proposed to help evaluate base line metrics and may be used as guidelines.

High priority: 45 days

Medium priority: 60 days

Low priority: 90 days

Changes to the due date after initiation require the use of the extension process.

The movement of the CAPA Request into CAPA Investigation marks the completion of the Assessment Phase and the beginning of the Investigation Phase.

4.4.5. Establish CAPA Priority The CAPA Priority Matrix in Table 1 will be used to establish CAPA Priority. The CAPA Priority may be set higher than indicated by the CAPA Priority Matrix, if appropriate, but is not permitted to be set lower. CAPA Priority may be changed if new information changes the risk during the CAPA lifecycle.

Table 1: CAPA Priority Matrix

Product in Field*

Patient Safety

Compliance CAPA

Priority

Yes Not Assessed High/Not High High

Yes High High/Not High High

Yes Medium High High

Yes Medium Not High Medium

Yes Low High High

Yes Low Not High Medium

Yes n/a High High

Yes n/a Not High Medium

No n/a High High

No n/a Not High Low

*If unknown, assign “Yes” value

Product in Field

Yes – Affected product is beyond Medtronic Control, or was retrieved for quality reasons from locations beyond Medtronic Control.

No – All affected product has been within Medtronic Control.

Compliance

High – 1. CAPA addresses external audit finding or other Regulatory actions (i.e. Warning Letter, 483, Major Nonconformance).



14.0




2. CAPA addresses failure to meet regulatory reporting requirements (i.e. late MDRs).

Not High – Does not meet the criteria for High.

Patient Safety – Determined per Policy 034, Product Risk Management

High – Maps to Zone 3

Med – Maps to Zone 2

Low – Maps to Zone 1

n/a – No Effect on Patient Safety

4.4.6. CAPA ScopeThe scope of a CAPA is designated as Global, Business Sector or Local. The CAPA Board has discretion to

raise an issue to a higher level than shown in the decision tree below.

Scope Criteria

Global For issues that impact the product/quality process where more than one business sector is affected and/or the issue is a high compliance risk that affects more than one business sector. (Includes more than one business)



14.0




Business Sector

Used for issues that impact the product /quality process within the business sector scope and/or the issue is a high compliance risk that affects only the business sector scope.

Local Used for issues that do not affect product in the field, and compliance risk is not high.

4.5. INVESTIGATION PHASE

4.5.1. Document Initial Correction and ContainmentThe CAPA Owner and/or CAPA Specialist shall review and document initial correction and containment actions relevant to the CAPA.

When the CAPA issue affects product (whether or not in the field), the CAPA record shall be owned by the board associated with the product. It is their responsibility to identify in the CAPA record what decisions have been made to contain the product; all decisions shall be in accordance with theProduct Hold Order Policy and Field Corrective Action Policy of the entity that owns the product.

Issues that do not affect product may have Corrections and Containment and, if so, these shall be documented or referenced in the CAPA record.

If no correction or containment actions are taken, the justification shall be documented.

4.5.2. Identify Investigation TeamThe CAPA Owner shall identify appropriate team members, as applicable.

The team shall include individuals from impacted functions to conduct a thorough investigation.

4.5.3. Investigate and Identify Root CauseThe depth of the investigation shall be based on the magnitude and severity of the problem.

The investigation includes determining the root cause (where possible). An appropriate method of root cause identification shall be used and documented within this phase.

Investigation and root cause results shall be documented in the CAPA.-

4.5.4. Create Corrective/Preventive Action PlanThe CAPA Owner shall identify the action plan.

If multiple root causes are identified during the Investigation, actions shall be taken to address each cause. If action is not taken on any one of the root causes, the rationale shall be documented.

If the decision is that no actions are required, the rationale shall be documented and approved by CAPA Specialist and CAPA Board Chair, at a minimum; the decision not to perform actions shall be communicated to the CAPA Requester.



14.0




4.5.5. Create Effectiveness StrategyThe effectiveness strategy shall define the method for determining that the corrective and preventive actions implemented are effective in addressing the root cause(s).

The method by which effectiveness is going to be performed, including acceptance criteria shall be documented in the CAPA Record. If a sampling plan if used, it must be statistically valid.

All corrective actions require effectiveness checks. Rationale shall be provided for other actions where effectiveness checks are not required.

4.5.6. Set the Action Phase Due DateThe Action Phase due date shall be set, taking into consideration the risk and the amount of work required.

The Action Phase due date shall also take into consideration the time required to implement actions, as applicable.

4.5.7. Investigation ReviewA task for the critical review of the root cause analysis will be part of the Investigation phase. It will help determine if the analysis is sufficient and if the Root Cause Review is complete. The Critical Review Analysis questionnaire will be completed and approved by a designated board member. (See appendix A for Critical Review Analysis).

4.5.8. Approval of Investigation Phase CompletionThe CAPA Board shall:

Review and confirm agreement of corrective and/or preventive action(s) and action due dates.

Ensure root cause is adequately addressed in corrective/preventive action(s). If corrective and/or preventive action(s) are not required, approve justification documented in CAPA Event.

If corrective action, preventive action, and/or justification are not approved, it will need to be determined if additional investigation needs to be done, the root cause needs to be re-reviewed or the action plan needs to be re-defined.

The date that the Investigation Phase is approved is the end date for the phase.

Completion of the CAPA Investigation Phase shall be approved by the CAPA Specialist and a CAPA Board Member, at a minimum.

CAPAs that remain in Investigation Phase for longer than 90 calendar days shall be reviewed by the Global IT CAPA board. A rationale for the time frame shall be documented in the CAPA record

4.6. ACTION PHASE

4.6.1. Action ExecutionImplementation of new and/or revised processes, procedures, or products as a result of the CAPA shall adhere to requirements of the relevant change process.

CAPAs that remain in action phase for longer than 180 calendar days shall be reviewed by the Global IT CAPA Board. A rationale for the time frame shall be documented in the CAPA record.



14.0




4.6.2. Verify/ValidatePrior to implementation, actions shall be verified and (if applicable) validated to ensure that such actions can be expected to address the causes and do not adversely affect the finished product.

Should implementation result in any impacts other than correction or removal of the root cause, those impacts shall be evaluated to ensure that they do not create any undesired consequences.

4.6.3. Implementation Results

Implementation Results of corrective and preventive actions shall be documented in the CAPA Record.

4.6.4. Set Effectiveness Phase Due DateThe Effectiveness Phase Due Date shall be established in accordance with the Effectiveness Strategy.

4.6.5. Approval of Action Phase CompletionCompletion of the CAPA Action Phase shall be approved by the CAPA Specialist and a CAPA Board Member, at a minimum.

The date that the Action Phase Completion is approved is the end date for the Action Phase.

4.7. EFFECTIVENESS PHASE

4.7.1. Execute & Summarize Effectiveness ResultsThe effectiveness plan is executed, and results documented.

A summary of the effectiveness results, including a conclusion as to the effectiveness or ineffectiveness of the CAPA, shall be documented.

CAPAs that remain in effectiveness phase for longer than 365 calendar days shall be reviewed by the Global IT CAPA Board. A rationale for the time frame shall be documented in the CAPA record.

4.7.2. Effectiveness Review and Approval/CAPA ClosureIf established acceptance criteria are met during the effectiveness check, the CAPA is approved for closure, as effective.

If established acceptance criteria are not met during the effectiveness check, the CAPA is approved for closure as ineffective and a new Mandatory CAPA shall be created; the new CAPA must reference the ineffective CAPA for traceability purposes.

The CAPA shall be approved for closure by the CAPA Specialist and a CAPA Board Member, at minimum.

Approval by the CAPA Specialist indicates that a CAPA review was performed and that the CAPA was found to be in conformance with CAPA and quality record processes.

Approval by the CAPA Board Member indicates that the evidence collected during the Effectiveness Phase supports the arrived upon conclusion (effective or ineffective) of the actions taken to address identified causes.



14.0




4.8. EXTENSIONS

4.8.1. Extension RequestCircumstances where extensions to phase due dates may be requested are limited to:

Changes in timeframes that are beyond the reasonable control of Medtronic PLC personnel (e.g. change in production volumes, qualification/validation failures, product return time, un-announced inspections).

Scope changes are required, or there are additional discoveries (root cause or actions) during CAPA Investigation or Action phases.

More time is needed, due to extenuating circumstances, to provide a thorough, high quality, CAPA investigation or action

Preventive only CAPAs, which by definition do not have an existing nonconforming event.

4.8.2. Extension Request documented in CAPARequest for extensions to phase due dates shall be documented within the CAPA record and include rationale.

At a minimum, the extension request shall include:

Tasks completed

Tasks pending completion

Reason for the extension

Risk of delaying corrective action(s)

Proposed Due Date

4.8.3. Required ApprovalsCAPA Extensions require the following approvals, at a minimum:

Per Global IT CAPA Board Governance

CAPA Owner’s Manager

Same approvers of the phase to be extended

4.9. MANAGEMENT REVIEWTo maintain the effectiveness of the CAPA process, Management with Executive Responsibility defines

measurements of the CAPA Process (CAPA Metrics) to be reviewed as part of the Management Review

process.

4.10. TRAININGThe following are the CAPA training requirements:

Depending upon your CAPA role (initiator, owner or process administrator), individuals shall take and

complete the assigned Global IT Role based training for the CAPA process.

CAPA training shall be documented in our Learning Management System.



14.0




DELIVERABLESDeliverable Title Description Record Code1

CAPA Records CAPA records developed to manage

Medtronic’s quality system

QMT 1000

CAPA Metrics Metrics for CAPA QMT 1000

Board Chair Designations Responsibilities for Board Chair QMT 1000

TrainingCAPA training records in Learning

Management SystemQMT 1300

1 See 70654 for record code definitions and length of time to retain the record. The start of the retention period begins upon approval of the deliverable.

APPROVALSSigning constitutes applying an approval signature prior to issuance. This approval indicates that the

approver has reviewed the document and finds it to be adequate, complete and correct. Approvals of

this document are maintained using the e-signature functionality of the validated document repository.

Approvers Role/Responsibility

Michael Branch Approver: Manager and Global IT QA Lead: Global IT Quality Compliance Management Director

Le Anne Eickhof Author: Global IT Quality System Representative

Darci Moon Approver: Global IT Quality System Representative



14.0




APPENDIX A– ROOT CAUSE CRITICAL REVIEW

A Critical Review of the Root Cause is performed by a CAPA Board Member as part of approving the root

cause. The following questions are answered based on the written CAPA record:

1. Was the problem scope appropriate and rationale provided? (Is the problem well bounded –

what, when, where, extent. Can it be fixed – is it in the organization’s span of control or

influence?)

2. Were the appropriate subject matter experts involved in determining or reviewing the root

cause and supporting work?

3. For CAPAs where the issue has occurred (Corrective): 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?

4. For CAPAs where the issue has not occurred (Preventative): Does the root cause analysis for

potential cause confirm the need for action to avoid a future problem?

5. Are the root cause analysis methods used appropriate for the type of problem or for the

understanding of the potential problem?

6. Is there a distinction between primary and contributing causes?

7. If the CAPA has a technical cause, has the CAPA owner considered if there is also a process root

cause?

8. If appropriate, were detection methods reviewed to determine if they permitted an escape of

the issue? (See note below for explanation)

9. If root cause could not be confirmed, is there compelling evidence for completing this phase

based on the information in the record?

10. Has business input been considered in determining risk priority when the CAPA’s scope has

business impact? If not, then indicate why it was not considered.

11. If the timeframe for the investigation exceeded 180 calendar days, does the Investigation

Summary include a rationale for why it requires that much time that aligns with quality and

business objectives.

If the answer is no to any of the questions or part of a question, indicate what the remediation or

rationale would be so that you could respond in the affirmative

Note: What process/system should have detected or prevented the issue initially. The answer can point

to processes/systems that either were not followed, or had gaps – and should be part of the

investigation. Or if there was not a process or system in place to prevent this, then it is not appropriate.



14.0




APPENDIX B – CAPA DETERMINATION QUESTIONS

Answer the questions with the information that you have regarding the CAPA issue.If you do not know the answer, state unknown.This is not a final determination if the issue is a CAPA, it is only a guide to help make an assessment.The Global IT CAPA Board makes the final determination.

CAPA PR (if known):Date:CAPA Descriptive Title:Name of Individual that completed questions:

CAPA DETERMINATION QUESTIONS YES NO

1.There is reasonable concern that there may be patient safety risk, complaint or

impact.

2. Is product affected? (either in the field or not)

3. Does the issue impact our ability to be compliant to any regulations?

4. Is the Quality system impacted (i.e. quality processes, work operations, quality

audit reports, quality records, service records, complaints, returned product or

other sources of quality data)?

5. This is a significant finding by notified body or regulatory agency, or a critical or

major finding from internal quality audit.

6. Is this an occurrence that is significant? (see note i)

7. Are there trends that would lead you to suspect an underlying systemic issue?

(see note ii)

8. Is this issue the result of a procedure that requires a CAPA? (see note iii)

9. The issue’s occurrence has exceeded a threshold established in a closed CAPA.

i. A single occurrence that is significant.

A significant occurrence is defined as being serious enough that the organization would not wait for a

second occurrence in order to take action because it could impact patient risk or compliance risk. If

escalation is not defined in local data source procedures, this would occur upon the discretion of the

data source originator to escalate to the CAPA board to determine if it warrants a CAPA.

ii. A trend is identified or suspected.

A trend is considered when it occurs more than one time and may or may not be statistically generated,

or if a threshold is exceeded, or if current performance is unfavorable from historical performance.



14.0




Example - Multiple tickets raised on the same issue over a period of time. Analysis should be completed

to understand if the event is an anomaly or part of a greater concern that could trigger a CAPA.

iii. A procedure that is already in place that requires a CAPA.

This includes any Quality System or other procedures that already require that a CAPA be opened.

(Example: Audit which requires CAPAs for Critical and Major Nonconformities, or Management Review

which may escalate an issue to a CAPA



14.0




APPENDIX C – TRACKWISE CAPA PR STATES AND ROLES

Role Flow -TrackWise CAPA PR States

CAPA Requester

CAPA Specialist

CAPA Board Chair / Member

CAPA Owner & Team

CAPA Specialist


CAPA Owner & Team

CAPA Specialist


CAPA Owner

CAPA Owner & Team

CAPA Owner

CAPA Specialist


End of Document



14.0



Documents

Medtronic Controlled Informationlmsgbl.medtronic.com/production/cninv000000000127331/content.pdf · (QMS-SOP) - Global IT Corrective and Preventive Action SOP. 86967-SOP. Medtronic