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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?
2
Please provide the reference number for the change documentation.
3
Does the change comply with ISO 14644 standards?
4
How many changes were reviewed during this process?
Min: 0
Target: 0
Max: 100
5
Please provide any additional notes from the quality assurance review.
6
Was a performance assessment conducted post-modification?
7
What is the justification for the cleanroom modification?
8
What is the date of the cleanroom modification implementation?
9
How many personnel were trained on the new cleanroom procedures?
Min: 0
Target: 0
Max: 50
10
Please provide any observations made after the modification.
11
Was the change approved by the necessary stakeholders?
12
Who was responsible for implementing the change?
13
When was the change last reviewed for effectiveness?
14
How many incident reports have been filed post-change?
Min: 0
Target: 0
Max: 20
15
What lessons were learned from this change management process?
16
Was a regulatory impact assessment performed prior to the change?
17
Provide a detailed description of the change made.
18
When was the change implemented?
19
How many follow-up audits are scheduled to assess the change?
Min: 0
Target: 0
Max: 10
20
Summarize any feedback received from stakeholders regarding the change.
21
Is all required documentation complete for the change?
22
What is the Change Request ID associated with this modification?
23
When was the final review of the change conducted?
24
How many changes were implemented in the last quarter?
Min: 0
Target: 0
Max: 50
25
Provide any notes regarding compliance issues related to this change.

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