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ISO 14644 Cleanroom Personnel Practices Audit Checklist

A comprehensive checklist for auditing personnel practices in pharmaceutical cleanrooms to ensure compliance with ISO 14644 standards, focusing on gowning procedures, hygiene protocols, behavior guidelines, and contamination control awareness to maintain cleanroom integrity.

ISO 14644 Cleanroom Personnel Practices Audit Checklist

by: audit-now
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About This Checklist

The ISO 14644 Cleanroom Personnel Practices Audit Checklist is an essential tool for ensuring that human factors do not compromise the integrity of pharmaceutical cleanrooms. This comprehensive checklist aligns with ISO 14644 standards, focusing on critical aspects of personnel behavior, gowning procedures, and contamination control practices. By systematically evaluating these human-centric elements, pharmaceutical companies can minimize the risk of personnel-induced contamination, maintain consistent cleanroom conditions, and ensure compliance with regulatory requirements. Regular implementation of this checklist enhances overall cleanroom performance, supports product quality, and reinforces a culture of contamination awareness among cleanroom staff.

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Industry

Healthcare

Standard

ISO 14644 - Cleanroom Standards

Workspaces

Pharmaceutical Facilities

Occupations

Cleanroom Operator
Quality Assurance Specialist
Cleanroom Supervisor
Training Coordinator
Contamination Control Officer
1
Is the gowning procedure followed correctly by all personnel?

Select compliance status.

To ensure that personnel are minimizing the risk of contamination.
2
How many hours of training have personnel completed in the last year?

Enter the total training hours.

To assess the training adequacy of personnel in contamination control.
Min: 0
Target: 20
Max: 100
3
Are hygiene protocols being adhered to at all times?

Indicate adherence to hygiene protocols.

To ensure that personnel are following hygiene protocols to prevent contamination.
4
Are the contamination control measures adequate?

Select the adequacy of contamination control measures.

To evaluate the effectiveness of contamination control in the cleanroom.
5
Are personnel following cleanroom behavior guidelines?

Select compliance status.

To ensure that personnel are maintaining proper behavior to minimize contamination risks.
6
What issues have been observed regarding personnel practices?

Provide details of any issues noted.

To document any observed issues that may lead to contamination.
7
How many incident reports have been filed in the last quarter?

Enter the number of incident reports.

To assess the frequency of contamination-related incidents.
Min: 0
Target: 0
Max: 50
8
When was the last training session conducted for personnel?

Select the date of the last training session.

To ensure that personnel are regularly trained in contamination control practices.
9
Please provide any comments or observations regarding the gowning procedure.

Enter your comments or observations.

To gather qualitative feedback on the effectiveness of gowning procedures.
10
How compliant are personnel with hygiene protocols?

Select adherence level.

To evaluate the adherence level to hygiene practices in the cleanroom.
11
What is the average contamination level observed in the cleanroom (in CFU/m³)?

Enter the average contamination level.

To monitor environmental control and contamination levels in the cleanroom.
Min: 0
Target: 10
Max: 100
12
When is the next scheduled training session for personnel?

Select the next training date.

To ensure that personnel are continually trained in contamination control.
13
How frequently do personnel comply with gowning procedures?

Select the frequency of gowning compliance.

To assess the consistency of adherence to gowning protocols.
14
Are personnel using personal protective equipment (PPE) as required?

Indicate if PPE is being used.

To ensure that PPE is consistently used to protect against contamination.
15
What percentage of personnel have completed the required training?

Enter the percentage of training completion.

To evaluate the level of training completion among staff.
Min: 0
Target: 100
Max: 100
16
What suggestions do you have for improving personnel practices?

Provide your suggestions for improvement.

To collect feedback for enhancing contamination control and personnel behavior.
17
Are personnel aware of contamination control procedures?

Select the level of awareness regarding contamination control.

To assess the level of awareness among staff regarding contamination control measures.
18
What specific incidents related to contamination have been reported?

Detail any reported incidents.

To document any specific contamination incidents for review.
19
What is the average turnover rate of cleanroom personnel over the last year (in %)?

Enter the average turnover rate.

To evaluate the stability of the cleanroom staff and its impact on compliance.
Min: 0
Target: 5
Max: 100
20
When was the last cleanroom audit conducted?

Select the date of the last audit.

To ensure that regular audits are being conducted to assess compliance.

FAQs

The checklist covers gowning procedures, hand hygiene practices, cleanroom entry and exit protocols, behavior within the cleanroom, training records, and understanding of contamination control principles.

By ensuring that personnel follow proper procedures and understand their role in contamination control, the checklist helps minimize human-induced contamination risks in the cleanroom environment.

The audit should involve quality assurance personnel, cleanroom supervisors, training coordinators, and contamination control specialists to ensure a comprehensive evaluation of all aspects of personnel practices.

Formal audits should be conducted quarterly, with ongoing daily observations of personnel practices. New staff should be audited more frequently during their initial period in the cleanroom.

Non-compliance should trigger immediate retraining of the individual(s) involved, review and possible revision of training programs, and increased monitoring of personnel practices. Serious or repeated non-compliance may require disciplinary action.

Benefits of ISO 14644 Cleanroom Personnel Practices Audit Checklist

Ensures personnel practices comply with ISO 14644 standards for cleanroom operations

Reduces risk of human-induced contamination in pharmaceutical cleanrooms

Promotes consistent adherence to gowning and hygiene protocols

Facilitates ongoing training and awareness of contamination control among staff

Supports documentation and traceability of personnel-related cleanroom activities