Get the free Control of Quality Records Procedure - FDA
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Responsible Office/Division
Title: MD SAP RMS Control of Quality
Records ProcedureDocument No.:
Page: 1 of 7
MD SAP RMS
P0007.005
Version Date:
Effective Date:
20190111
20190115
Project Managers:
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How to fill out control of quality records
How to fill out control of quality records
01
To fill out control of quality records, follow these steps:
02
Obtain the necessary quality control forms or templates.
03
Start by entering the basic information such as the date, project/reference number, and person responsible for the record.
04
Identify the specific process or procedure being recorded.
05
Document the details of the quality control activities performed, such as inspections, tests, or audits.
06
Provide a clear description of any non-conformities or deviations found during the quality control process.
07
Include information about any corrective actions taken to address the non-conformities.
08
If applicable, record the results of follow-up inspections or tests to verify the effectiveness of the corrective actions.
09
Obtain necessary signatures and approvals from relevant stakeholders.
10
Safely store the completed quality control records for future reference or audits.
11
Regularly review and update the control of quality records process to ensure its effectiveness.
Who needs control of quality records?
01
Control of quality records is important for various stakeholders including:
02
- Organizations that have quality management systems (QMS) in place and need to comply with relevant standards and regulations.
03
- Project managers and supervisors who are responsible for ensuring the quality of deliverables and meeting customer requirements.
04
- Quality control personnel who perform inspections, tests, and audits to monitor and improve product or service quality.
05
- Auditors who assess the compliance and effectiveness of the organization's quality control processes.
06
- Customers or clients who may request or require access to quality control records as evidence of quality assurance.
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