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ISO 14644 Cleanroom Garment Management Audit Checklist

A detailed checklist for auditing cleanroom garment management practices in pharmaceutical facilities to ensure compliance with ISO 14644 standards, focusing on garment selection, maintenance, handling procedures, and lifecycle management to maintain cleanroom integrity and prevent contamination.

ISO 14644 Cleanroom Garment Management Audit Checklist

by: audit-now
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About This Checklist

The ISO 14644 Cleanroom Garment Management Audit Checklist is an essential tool for ensuring the integrity of cleanroom garments in pharmaceutical manufacturing environments. This comprehensive checklist aligns with ISO 14644 standards, focusing on the selection, maintenance, cleaning, and handling of cleanroom apparel. By systematically evaluating garment management practices, pharmaceutical companies can minimize the risk of garment-related contamination, maintain cleanroom classification, and ensure compliance with regulatory requirements. Regular implementation of this checklist enhances overall contamination control, supports product quality, and reinforces best practices in cleanroom garment management.

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Industry

Healthcare

Standard

ISO 14644 - Cleanroom Standards

Workspaces

Pharmaceutical Facilities

Occupations

Cleanroom Manager
Quality Assurance Specialist
Contamination Control Officer
Cleanroom Garment Technician
Pharmaceutical Production Supervisor
1
Is the integrity of the cleanroom garments maintained?
2
Are there records of garment laundering?
3
What is the total count of cleanroom garments available?
Min: 0
Target: 20
Max: 100
4
Are the donning procedures for cleanroom garments followed?
5
Was a garment inspection performed before entering the cleanroom?
6
Are the types of garments used compliant with ISO 14644 standards?
7
How many personnel are currently using cleanroom garments?
Min: 1
Target: 10
Max: 100
8
Please provide any notes regarding issues with garments.
9
Was a quality control inspection performed on cleanroom garments?
10
What were the findings from the latest quality control inspection?
11
What is the current defect rate of cleanroom garments?
Min: 0
Target: 2
Max: 100
12
When was the last garment quality review conducted?

FAQs

The checklist covers garment selection criteria, laundering and sterilization processes, storage conditions, donning and doffing procedures, garment integrity checks, and disposal practices for contaminated or worn-out garments.

Well-managed cleanroom garments act as an effective barrier against human-generated particles and microorganisms, helping to maintain the required cleanliness levels and prevent contamination.

The audit should involve cleanroom managers, quality assurance personnel, garment suppliers or laundry service providers, and contamination control specialists to ensure a comprehensive evaluation of all aspects of garment management.

Comprehensive audits should be conducted quarterly, with more frequent spot checks on critical aspects such as garment integrity and donning procedures. Laundry facilities should be audited at least annually.

Deficiencies should trigger immediate corrective actions, including retraining of personnel, revision of garment handling procedures, or reevaluation of garment suppliers. Follow-up audits should be scheduled to verify the effectiveness of these actions.

Benefits of ISO 14644 Cleanroom Garment Management Audit Checklist

Ensures cleanroom garment practices comply with ISO 14644 standards

Reduces risk of contamination from improperly managed cleanroom apparel

Promotes consistent adherence to garment donning and doffing procedures

Facilitates proper maintenance and lifecycle management of cleanroom garments

Supports overall contamination control strategy in pharmaceutical cleanrooms