Using an Internal Audit Checklist

Audit checklists serve as an indispensable tool for conducting internal audits, with items like audit questions and an opportunity assessment form included for internal auditors to use when performing internal reviews.

Medical device companies must conduct an internal audit regularly in order to ensure all processes are operating efficiently and correctly. An internal audit provides the ideal way of doing this.

Process Inputs
Conducting an internal audit is vital to ensuring your company’s Quality Management System (QMS) complies with ISO standards. You can streamline this process using an internal audit checklist.

The initial part of a process audit checklist contains audit questions designed to gauge how well processes are being carried out, such as checking that all materials are utilized as intended and that interfaces between departments work as they should.

One important focus of the checklist is identifying opportunities for improvement, which includes verifying that staff can track progress on improvement plans. Documentation and records also receive significant consideration in this section of the check list.

Process Outputs
As part of your internal audit checklist, in this section you will be reviewing outputs of processes. This should be easy for auditors to grasp as tangible outcomes can easily be measured and quantified.

Example activities could include conducting customer satisfaction surveys or testing to verify that records are secure and only authorized users have access to them. This part is extremely crucial as it shows your company’s capacity for data flow management and compliance tracking.

Process audits also help quality managers identify areas that are underperforming, and suggest solutions for improvement. An internal audit provides these vital services!

Documentation and Records
At this stage of an audit, auditors will scrutinize records and methods used to verify training. They will also assess how the PDCA cycle is working for your company and whether there are opportunities for improvements.

Documentation and records are vital components of any company. When an FDA inspector or ISO registrar notices documentation that falls below standard, they will issue a warning letter and issue sanctions accordingly.

The 21 CFR Part 11 Internal Audit Checklist assists regulated companies in meeting this requirement by recording electronic records, signatures, validation systems and any proofs of compliance, points for improvement or gaps that exist in compliance. The checklist allows companies to record proofs of compliance as well as any proofs of improvement or gaps present.

Production and Process Controls
This section’s goal is to ensure your production processes can produce products that fulfill specifications. This means confirming traceability for raw materials and components used, as well as reviewing warehousing and distribution records.

Audit this section early in your process so you can use its findings later to enhance the traceability of your device and reduce recall risk when readying it for market.

Make sure your automated system enables document collaboration and approvals, which is necessary to meet 21 CFR Part 11 regulations.

Customer-Related Processes
The final section of the checklist addresses customer-related processes. This involves making sure procedures exist to review customer complaints and manage them effectively – an area of particular focus for an FDA or ISO auditor, given how poor complaint management has led to medical device manufacturers receiving warning letters in the past.

This CFR 21 internal audit checklist PDF offers an all-in-one solution for auditing your quality system against ISO and FDA standards. It covers all of the specific clauses related to customer sales orders and product documentation as required by ISO 13485 – making this an accessible and helpful way of auditing ISO 13485 processes.

Design and Development
Auditing your design and development processes is key for both ISO and FDA regulators, who want to see that your medical device company has established an adequate process to review any modifications to designs that have been risk assessed, approved, and monitored for impact.

Your organization must also implement processes and systems for effectively handling complaints and taking corrective and preventive actions (CAPAs). An ineffective complaint management system has been one of the leading causes of regulatory warning letters.

Utilising quality management software can make conducting internal audits much simpler. Qualio’s cloud-based platform makes audits quick and transparent – helping you stay in compliance all year round and pass external inspections effortlessly! Request a demo now to experience it for yourself!