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documentation checklist

Manufacturing Process Documentation

Process Flowchart:* Ensure a detailed flowchart is created for each manufacturing process, depicting all steps, inputs, outputs, and decision points.

Standard Operating Procedures (SOPs):* Verify that SOPs are developed for each process, clearly outlining step-by-step instructions and safety precautions.

Work Instructions:* Confirm the availability of work instructions for various tasks, providing specific guidance on how to perform them correctly.

Bill of Materials (BOM):* Validate that accurate BOMs are maintained for each product, listing all necessary components and their quantities.

Equipment Manuals:* Check if comprehensive manuals are available for all machinery and equipment used in the manufacturing process.

Maintenance Logs:* Ensure that maintenance logs are regularly updated, documenting all maintenance activities performed on the equipment.

Quality Control Documentation

Quality Control Plan:* Verify the existence of a comprehensive plan detailing quality control procedures, including inspection and testing methods.

Inspection Checklists:* Confirm the availability of specific checklists for inspecting raw materials, work-in-progress, and finished goods.

Test Reports:* Validate that test reports are generated after conducting quality tests, providing detailed information on test results and compliance.

Non-Conformance Reports (NCRs):* Check if NCRs are filed for any deviations or non-compliance identified during inspection or testing processes.

Corrective and Preventive Actions (CAPAs):* Ensure that CAPAs are documented for addressing identified non-conformances and preventing their recurrence.

Safety Documentation

Safety Policies:* Verify that documented safety policies and procedures are in place, highlighting safety guidelines for employees.

Safety Data Sheets (SDS):* Confirm the availability of SDS for all chemicals and hazardous materials used in the manufacturing process.

Training Records:* Check if records of safety training provided to employees are maintained, ensuring compliance with safety regulations.

Incident Reports:* Ensure that incident reports are filed for any accidents, injuries, or near-miss incidents occurring in the manufacturing facility.

Emergency Response Plan:* Validate the existence of an emergency response plan, clearly outlining procedures to be followed in case of emergencies.

Regulatory Compliance Documentation

Permits and Licenses:* Verify that all necessary permits and licenses required for manufacturing operations are obtained and renewed.

Product Certifications:* Check if relevant product certifications, such as ISO, CE, or industry-specific certifications, are obtained and maintained.

Audit Reports:* Ensure that audit reports conducted by internal or external auditors are documented, highlighting areas of improvement.

Regulatory Filings:* Confirm that all required regulatory filings, such as environmental reports or safety inspections, are completed and documented.

Supplier Documentation:* Validate the availability of documentation related to suppliers, including contracts, quality certifications, and audits.

Note: This checklist is intended as a general guideline and may require customization based on specific manufacturing organization requirements and industry regulations.

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