Management of Change Quality Review Checklist [FREE PDF]

Management of Change (MOC) is a critical quality system requirement under ISO 9001:2015 Clause 6.3, mandating that organizations plan and control changes to the QMS in a systematic manner. Failure to properly evaluate and document process changes can introduce uncontrolled risks, product nonconformances, and regulatory violations. This checklist guides Quality Managers through a structured MOC quality review to verify risk assessment, stakeholder approval, implementation controls, and post-chang

Industry: Manufacturing
Frequency: Per Event
Estimated Time: 35-50 minutes
Role: Quality Manager
Total Items: 37
Compliance: ISO 9001:2015 Clause 6.3 - Planning of Changes, ISO 9001:2015 Clause 8.5.6 - Control of Changes, IATF 16949:2016 Clause 8.5.6.1 - Control of Changes - Supplemental, AS9100 Rev D Clause 8.5.6 - Control of Changes, ISO 19011:2018 Clause 6.4 - Performing the Audit

Change Initiation and Documentation

Verify that the change request is properly initiated, documented, and contains all required baseline information before review proceeds.

Has a formal Change Request form been completed with a unique identifier assigned?
Does the change request clearly describe the current state and the proposed change in sufficient detail?
Has the originator of the change request been identified and their contact information recorded?
Has the business justification or reason for the change been documented?
Has the proposed effective date and implementation timeline been specified in the change request?

Risk Assessment and Impact Analysis

Confirm that a comprehensive risk assessment and impact analysis has been performed to evaluate potential consequences of the proposed change.

Has a formal risk assessment been conducted using an approved methodology (e.g., FMEA, risk matrix)?
Have all affected processes, products, and services been identified in the impact analysis?
Have customer-specific requirements been evaluated for impact by the proposed change?
Has the risk assessment identified and documented all mitigation actions required before change implementation?
Have regulatory or statutory compliance implications of the change been evaluated?
Has a Risk Priority Number (RPN) or equivalent risk score been assigned and documented?

Approval and Authorization

Verify that the change has received appropriate approvals from all required stakeholders, including customer notification where mandated.

Has the change been reviewed and approved by the Quality Manager or designated authority?
Have all cross-functional stakeholders (engineering, operations, supply chain) provided documented approval?
Where required by contract or customer-specific requirements, has formal customer approval been obtained prior to implementation?
Is the approval record dated and does it include the approver's name and title?
Has any conditional approval been documented with specific actions required before implementation?

Documentation and Procedure Updates

Ensure all affected documentation including procedures, work instructions, control plans, and specifications are identified and updated as part of the change.

Has a complete list of all documents requiring revision been identified and included in the MOC package?
Have all relevant procedures and work instructions been updated to reflect the change?
Have Control Plans and Process FMEAs been revised where applicable?
Have obsolete versions of updated documents been removed from point of use and properly archived?
Have document revision levels been incremented and change history updated for all revised documents?

Training and Communication

Confirm that all personnel affected by the change have been trained and that the change has been communicated to relevant internal and external parties.

Has a training needs assessment been completed to identify all personnel requiring training on the change?
Has training been delivered and documented with attendance records for all affected personnel?
Have affected suppliers or subcontractors been notified of changes that may impact their deliverables?
Has internal communication been distributed to all departments affected by the change?
Are training effectiveness records available to verify that personnel have understood and can apply the change?

Implementation and Verification

Verify that the change has been implemented as planned, with appropriate controls and verification activities completed to confirm effectiveness.

Has a pre-implementation checklist or go-live readiness review been completed before activating the change?
Were first article inspections or process validation runs performed to verify the change produces conforming output?
Have all risk mitigation actions identified during the risk assessment been completed and verified?
Has a rollback or contingency plan been documented and is it readily accessible if the change needs to be reversed?
Has the implementation date and responsible person been recorded in the MOC record?

Post-Change Monitoring and Closure

Confirm that a monitoring period has been established to assess change effectiveness and that the MOC record is properly closed and archived.

Has a defined post-implementation monitoring period been established with specific performance metrics to track?
Have monitoring results been reviewed against defined acceptance criteria to confirm change effectiveness?
Has the MOC record been formally closed with a closure date and responsible authority signature?
Has the completed MOC record been filed in the document management system with appropriate retention period assigned?
Have lessons learned from this change been captured and shared for use in future MOC processes?
Have any nonconformances or issues identified during or after implementation been linked to corrective action records?

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Why Use This Management of Change Quality Review Checklist [FREE PDF]?

This management of change quality review checklist [free pdf] helps manufacturing teams maintain compliance and operational excellence. Designed for quality manager professionals, this checklist covers 37 critical inspection points across 7 sections. Recommended frequency: per event.

Ensures compliance with ISO 9001:2015 Clause 6.3 - Planning of Changes, ISO 9001:2015 Clause 8.5.6 - Control of Changes, IATF 16949:2016 Clause 8.5.6.1 - Control of Changes - Supplemental, AS9100 Rev D Clause 8.5.6 - Control of Changes, ISO 19011:2018 Clause 6.4 - Performing the Audit. Regulatory-aligned for audit readiness and inspection documentation.

Frequently Asked Questions

What does the Management of Change Quality Review Checklist [FREE PDF] cover?

This checklist covers 37 inspection items across 7 sections: Change Initiation and Documentation, Risk Assessment and Impact Analysis, Approval and Authorization, Documentation and Procedure Updates, Training and Communication, Implementation and Verification, Post-Change Monitoring and Closure. It is designed for manufacturing operations and compliance.

How often should this checklist be completed?

This checklist should be completed per event. Each completion takes approximately 35-50 minutes.

Who should use this Management of Change Quality Review Checklist [FREE PDF]?

This checklist is designed for Quality Manager professionals in the manufacturing industry. It can be used for self-assessments, team audits, and regulatory compliance documentation.

Can I download this checklist as a PDF?

Yes, this checklist is available as a free PDF download. You can also use it digitally in the POPProbe mobile app for real-time data capture, photo documentation, and automatic reporting.