The purpose of this Standard Operating Procedure (SOP) is to establish guidelines and requirements for the qualification of personnel gowning in order to maintain the highest level of cleanliness and hygiene within the facility.
This SOP applies to all personnel working in controlled environments where gowning is mandatory to prevent contamination, such as cleanrooms, sterile manufacturing areas, and other designated clean areas.
3. Facility Management
- Ensure the implementation of this SOP and its compliance by all personnel.
- Provide necessary resources for gowning materials and training.
4. Quality Assurance
- Oversee the gowning qualification process and ensure its adherence to established procedures.
- Conduct regular audits to verify compliance and identify opportunities for improvement.
5. Training Department
- Develop and deliver gowning training programs to all personnel.
- Maintain records of gowning training and qualification status for each individual.
- Comply with the gowning qualification process and ensure proper gowning at all times.
- Report any issues or concerns related to gowning to the relevant authorities.
Heading 2: Gowning Requirements
7. Gowning Levels
There are different gowning levels based on the level of cleanliness required in specific areas. Personnel must be qualified for each applicable gowning level before entering the respective areas.
8. Gowning Procedures
Detailed gowning procedures will be provided during the training sessions. These procedures should be followed meticulously to ensure effective contamination control.
All personnel required to enter controlled environments must undergo the gowning qualification process.
10. Initial Training
- Personnel will attend the initial gowning training conducted by the Training Department.
- The training will cover gowning procedures, cleanroom behavior, and contamination prevention measures.
11. Written Test
- Following the training, personnel will take a written test to assess their understanding of the gowning procedures and cleanliness requirements.
12. Practical Demonstration
- After passing the written test, personnel will undergo a practical demonstration of gowning procedures in a controlled environment.
- The demonstration will be evaluated by qualified assessors from the Quality Assurance team.
13. Gowning Proficiency
- Personnel who pass both the written test and practical demonstration will be considered qualified for the specific gowning level.
- Gowning proficiency status will be recorded by the Training Department.
14. Periodic Retraining
- Personnel must undergo periodic retraining for gowning procedures to reinforce their knowledge and address any updates or changes.
- The frequency of retraining will be determined based on the gowning level and the risk associated with the controlled environment.
- Recertification may be required if a personnel’s gowning proficiency is in question or if they have been absent from gowning areas for an extended period.
- Recertification will follow the same process as the initial qualification.
- The Training Department will maintain records of personnel gowning qualification status, including initial training, test scores, practical demonstration results, and retraining dates.
17. Access to Controlled Environments
- Access to controlled environments will be granted only to personnel with valid gowning qualification records.
18. Record Retention
- Gowning qualification records will be retained in accordance with the facility’s record retention policy.
Heading 2: Non-Compliance and Corrective Actions
- Any instances of non-compliance with gowning procedures or failure to meet qualification standards will be reported to the Quality Assurance team.
20. Corrective Actions
- The Quality Assurance team will investigate non-compliance and implement corrective actions as necessary, which may include additional training, retesting, or other appropriate measures.
Heading 2: Revision History
21. Document Revision
- This SOP will be reviewed periodically to ensure its effectiveness and relevance.
- Any necessary revisions will be made with proper approval and communicated to all personnel.
- This SOP has been reviewed and approved by the authorized personnel.
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