Supplier Audit

Conduct pre-audit research before reaching the audit site

In this step, it is important to understand the parties’ expectations. Similarly, the audit committee must prepare a prioritized checklist of items to review along with a list of products or services supplied. Other pre-audit research items include a review of:

• past audit reports
• supplier history with the company
• existing product specifications
• product performance
• interviews with in-house personnel about the supplier and the product

Do thorough research on the supplier's reputation online

Leverage the power of the internet to investigate the supplier. Research the supplier’s website and digital channels, read reviews from Consumer Reports and the Better Business Bureau and search the FDA website for information relevant to suppliers’ compliance with CGMP regulations to check for warning letters.

Investigate customer complaints

Customer complaints are a source of information about the performance and quality of products. To that end, looking into each complaint with a fine toothcomb is important. If there is repetitiveness in the type of complaint, understand the root cause for the same. This helps understand if the supplier is at fault, and this information can become part of the supplier audit process for further investigation.

Know your supplier's activity

If a part of the products your business procures comes from your supplier’s supplier, it is mandatory to be notified of the fact. Their relationship also impacts the quality of your products; hence, all parties involved with the company must adhere to the supplier quality agreements. Request your immediate supplier to furnish an audit report or any other documentation that validates their claim to meet your quality standards. This process is paramount to the overall quality output of your business.

Ensure that the supplier quality audits are always on track

While reviewing processes and documents during an audit, actively listen to the supplier. The supplier’s role is to follow the protocol and ensure that the auditor is granted access to all quality-related documents and processes. If the supplier or his team tries to offer incomplete or lukewarm responses, it could be a way to avoid the situation. These should become a part of the audit report as it could mean problems such as deviations, non-conformances, or failed lots.