The Supplier Quality Assurance Audit Checklist

An audit of supplier quality assurance practices can be an invaluable asset in any manufacturing environment. An audit assesses established practices like control of training, documentation and records management, inspection and testing as well as managing nonconformances.

Additionally, this process ensures the review and validation of customer drawings/specification requirements (particularly safety critical characteristics) so as to guarantee only quality-capable suppliers are used in serial production.

1. Documentation
Medical device and pharmaceutical manufacturers must adhere to various regulatory requirements when producing final products, including complying with CGMP regulations, quality assurance programs and supplier audits. These inspections help ensure products and processes meet company standards while mitigating risk from outside suppliers.

Documentation is a critical part of supplier quality audits. This includes audit plans, requirements and documentation. It is crucial that documents are stored, labeled and organized efficiently so as to reduce time spent searching for documents while increasing efficiency.

Ideal suppliers should have documented procedures in place for handling both internal and customer complaints, so as to better identify their cause and find areas for improvements. In addition, suppliers should implement an efficient monitoring and documenting system to track process changes and make sure they’re implemented as promised.

2. Customer Complaints
At any business, having an effective system in place that monitors and verifies the quality of raw materials, components and services provided by suppliers is vital to meeting regulatory standards. This is especially relevant to manufacturers of medical devices or pharmaceutical products who must abide by stringent government requirements.

At every supplier audit, it’s crucial that customer complaints are scrutinized carefully. If any recurring problems exist, these must be examined thoroughly in order to understand their source and implement appropriate corrective actions.

Dependent upon your product or service need, including field failure analysis into your supplier audit may also help save money by decreasing waste generated from defects in finished products and by early identification and resolution of potential quality issues that might otherwise become larger issues – which ultimately lead to greater customer satisfaction and increased profitability for your business.

3. Observation
Auditors use this section of their checklist to conduct an inspection at supplier facilities to understand their size and operations, their quality systems and processes as well as whether their production lines can produce quality goods in an efficient and safe manner.

Understanding your company’s complaint handling processes is also critical for understanding any patterns or recurring issues during an audit, which could form the basis of further examination during that process.

Medical device and pharmaceutical industries demand stringent standards from suppliers when purchasing materials, components, and services from them. Screening and monitoring suppliers is crucial in mitigating risks such as poor quality, damaged reputation, noncompliance fines, supply disruption and patient safety incidents. A factory audit can be an invaluable way to ensure all new suppliers meet an organization’s quality standards by reviewing quality management system documentation, production planning details, product verification procedures and validation practices.

4. Interviews
Companies operating in highly regulated industries such as medical devices or pharmaceuticals must implement systems to monitor the quality of raw materials and components purchased from suppliers, using tools like supplier quality assurance audits as an essential means to assess whether or not suppliers can produce high-quality products.

This process is handled by a team from within the buyer organization, such as procurement or quality departments. They will determine which items need to be checked during an inspection based on specific business needs and create an inspection list accordingly.

Inspections may take the form of announced or unannounced visits. An announced audit provides suppliers with notice ahead of time that an inspection team will visit, giving them time to enhance their processes ahead of time and address any potential issues during inspection. Conversely, in unannounced visits the inspectors arrive unannounced to assess operations without prior notification from management.