Internal Audit Checklist for Design and Development

An internal audit checklist is an indispensable tool for monitoring and evaluating business processes. It compares planned activities against system requirements in order to assess all clauses.

Medical device manufacturers frequently rely on internal audits to assess whether their quality management systems comply with industry standards, which can help improve audit outcomes and decrease time taken to conduct one.

Requirements Management
An effective internal audit checklist should include questions that are clear and specific to achieve accurate audit results. Vague or vague questions can cause false alarms during audits and lead to inaccuracy of results. Having an efficient internal audit checklist also aids in creating a more efficient audit process.

An internal audit is a review of current business practices to ensure they comply with industry standards. An internal audit can help mitigate risks while also identifying areas needing improvement to reach company goals.

Medical device companies need to ensure they can produce devices that meet user needs and specifications, including verifying purchasing controls, production controls, design validation processes and software testing of their product (if it contains software). Internal audits may take time but a good audit checklist will speed the process along.

Design Validation
An internal audit checklist allows managers to effectively ensure their organization’s quality management system is functioning effectively and minimize risks of noncompliance during audits that could prevent an organization from attaining ISO certification. The checklist helps assess conformance to audit criteria derived from standards like ISO 9001:2015.

Early evaluation of design input verification should be a top priority, to avoid wasted time and effort during product development cycles. Testing methods include mathematical modeling or simulation that dupe device functionality – with results documented in a Validation Report.

Change Management
Change management can be one of the more complex components to audit, as it has numerous interlinks with other sections and items; product design will likely serve as input into production; therefore it’s crucial that this section be thoroughly audited with all links thoroughly checked out.

An internal audit checklist can reduce the risk of noncompliance during critical audits for certification purposes, and can also serve to ensure each clause of system requirements are assessed and implemented in an efficient way. Likewise, process auditing can help ensure consistent business processes – making internal audit a key player in change management with invaluable assurance to offer your organisation.

Quality Assurance
Design and development is one of the core areas of an internal audit checklist that spans multiple components, such as making sure designs are transferrable into production, reconciling contract/order requirements that differ from product requirements, and reviewing documentation for completeness, accuracy, and clarity.

Verifying that documentation and records can be easily located during an inspection by external auditors includes reviewing procedures for identification, storage, security, retrieval, distribution, disposal and changes to documentation and records. It also ensures processes include an effective system to collect customer communications and feedback reports before tracking down trends and performance indicators to measure effectiveness of quality assurance processes.

Training
When an internal audit identifies issues, you must take immediate steps to rectify them. Use general internal audit procedures which consist of four basic steps – preparation, execution, reporting and monitoring.

Use a template as a roadmap for conducting internal audits for your medical device design and development process. The most vital parts of an audit checklist are those which directly connect with other components of the system – this applies especially well when auditing design and development activities.

This section includes numerous cross-references with other areas, such as your quality management system and documentation and records systems. However, it should also be noted that any issues raised here should already have complaint handling procedures in place for handling any potential problems that this section uncovers.