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ISO 14644 Cleanroom Change Control Audit Checklist

A comprehensive checklist for auditing change control processes in pharmaceutical cleanrooms to ensure compliance with ISO 14644 standards, focusing on the evaluation, implementation, and documentation of changes that may impact cleanroom operations, classification, or performance.

ISO 14644 Cleanroom Change Control Audit Checklist

by: audit-now
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About This Checklist

The ISO 14644 Cleanroom Change Control Audit Checklist is an essential tool for managing and documenting changes in pharmaceutical cleanroom environments. This comprehensive checklist aligns with ISO 14644 standards, focusing on the evaluation, implementation, and documentation of changes that may impact cleanroom operations, classification, or performance. By systematically auditing change control processes, pharmaceutical companies can maintain cleanroom integrity, ensure regulatory compliance, and minimize risks associated with modifications to cleanroom systems, equipment, or procedures. Regular implementation of this checklist supports continuous improvement, enhances traceability, and reinforces a culture of controlled and well-documented change in cleanroom management.

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Industry

Healthcare

Standard

ISO 14644 - Cleanroom Standards

Workspaces

Pharmaceutical Facilities

Occupations

Quality Assurance Specialist
Cleanroom Manager
Change Control Coordinator
Regulatory Affairs Officer
Cleanroom Engineer
1
Was a change impact assessment conducted prior to the modification?

Select the appropriate response.

To ensure that potential impacts of changes are evaluated to maintain compliance.
2
Please provide the reference number for the change documentation.

Enter the reference number.

To track and verify the documentation associated with the change.
3
Does the change comply with ISO 14644 standards?

Select true if compliant, false otherwise.

To verify that changes adhere to regulatory compliance standards.
4
How many changes were reviewed during this process?

Enter the number of changes reviewed.

To assess the thoroughness of the change review process.
Min: 0
Target: 0
Max: 100
5
Please provide any additional notes from the quality assurance review.

Add any relevant notes.

To capture any important observations or actions taken during the review.
6
Was a performance assessment conducted post-modification?

Select the appropriate response.

To ensure that the cleanroom maintains its required performance levels after modifications.
7
What is the justification for the cleanroom modification?

Provide a brief justification.

To document the rationale behind the changes for future reference and compliance.
8
What is the date of the cleanroom modification implementation?

Select the implementation date.

To establish a timeline for the modification process.
9
How many personnel were trained on the new cleanroom procedures?

Enter the number of trained personnel.

To ensure that all relevant personnel are adequately trained following modifications.
Min: 0
Target: 0
Max: 50
10
Please provide any observations made after the modification.

Add any relevant observations.

To capture any issues or improvements noted after changes were implemented.
11
Was the change approved by the necessary stakeholders?

Select the appropriate response.

To ensure that all changes are properly vetted and approved to maintain compliance.
12
Who was responsible for implementing the change?

Enter the names of the team members.

To identify the team or individuals involved in the change process.
13
When was the change last reviewed for effectiveness?

Select the review date.

To ensure regular reviews are conducted to evaluate the effectiveness of changes.
14
How many incident reports have been filed post-change?

Enter the number of incident reports.

To assess the impact of changes on operational performance.
Min: 0
Target: 0
Max: 20
15
What lessons were learned from this change management process?

Add any relevant lessons learned.

To document insights gained for future change management efforts.
16
Was a regulatory impact assessment performed prior to the change?

Select the appropriate response.

To confirm that any regulatory implications of the change have been assessed.
17
Provide a detailed description of the change made.

Enter a detailed description.

To document the specifics of the change for regulatory and quality assurance purposes.
18
When was the change implemented?

Select the implementation date and time.

To keep a precise record of when the change was made.
19
How many follow-up audits are scheduled to assess the change?

Enter the number of scheduled audits.

To ensure that adequate follow-up measures are in place to monitor the change.
Min: 0
Target: 0
Max: 10
20
Summarize any feedback received from stakeholders regarding the change.

Add any relevant feedback.

To capture stakeholder perspectives and improve future change management processes.
21
Is all required documentation complete for the change?

Select the appropriate response.

To ensure that all necessary documentation has been finalized for compliance and review.
22
What is the Change Request ID associated with this modification?

Enter the Change Request ID.

To track changes through a unique identifier for auditing purposes.
23
When was the final review of the change conducted?

Select the final review date.

To confirm that a final review has been completed as part of the change control process.
24
How many changes were implemented in the last quarter?

Enter the number of changes.

To analyze the volume of changes and ensure proper management practices are in place.
Min: 0
Target: 0
Max: 50
25
Provide any notes regarding compliance issues related to this change.

Add any compliance-related notes.

To document any compliance concerns that need to be addressed.

FAQs

The checklist covers change request procedures, risk assessments for proposed changes, approval processes, implementation plans, post-change verification, documentation updates, and training requirements related to cleanroom modifications.

By ensuring that all changes are properly evaluated, implemented, and documented, change control helps maintain cleanroom performance, prevents unintended consequences, and ensures ongoing compliance with cleanroom standards.

The audit should involve quality assurance personnel, cleanroom managers, engineering specialists, regulatory affairs officers, and relevant subject matter experts depending on the nature of the changes being reviewed.

Comprehensive change control audits should be conducted quarterly, with ongoing reviews of individual change requests as they occur. Major changes should trigger immediate audits of the change control process.

Identified deficiencies should prompt a review of the change control system, including revision of procedures, retraining of personnel, and potentially reversing or re-evaluating recent changes. A follow-up audit should be scheduled to verify the effectiveness of corrective actions.

Benefits of ISO 14644 Cleanroom Change Control Audit Checklist

Ensures changes in cleanroom environments comply with ISO 14644 standards

Minimizes risks associated with modifications to cleanroom systems or procedures

Enhances traceability and documentation of cleanroom alterations

Supports regulatory compliance by demonstrating controlled change management

Facilitates impact assessment of changes on cleanroom classification and performance