How to Perform a Supplier Qualification Audit?



Companies selling medical devices or pharmaceuticals are required by applicable regulations and standards to monitor the quality of the raw materials, components, and services that go into their products.


For this reason, it is crucial that manufacturers have systems in place to ensure that purchases meet acceptable quality requirements. One essential and prevailing tool for this is the supplier quality audit.


While there are many benefits of performing supplier quality audits, here are 4 of the biggest:

- Minimization of Risk

- Ensure compliance

- Maximize Return on Investment


How to Conduct a Supplier Quality Audit

An ideal audit should be both efficient and cost-effective, and should be designed to identify existing and potential risks.


The following are the essential steps to perform a supplier quality audit:


Step 1: Pre-audit data collection

Successful planning of quality audits starts with the pre-audit data preparations. This process involves collecting, collating, and analyzing all relevant data to help develop the audit type, duration, scope, and specific objectives.


Step 2: Preparation

This step is where scheduling and logistics are arranged, the audit plan is defined, and audit teams are identified.


Step 3: Performing the audit

The auditing process generally follows the procedure outlined below:

  • Hold an opening meeting
  • Take a tour
  • Obtain relevant evidence
  • Closing meeting


Step 4: Generation of an audit report

  • An audit report is a critical part of the auditing processes.
  • Audit reports serve as documented evidence that the audit occurred and that any deficiencies are recorded.
  • The audit reports should be drafted within a maximum of 3 weeks after the audit and be signed by the auditor when completed.
  • The report should provide a record that identifies areas of weaknesses that need improvement.


Step 5: Follow up

  • Auditors should plan for followup to ensure timely implementation of corrective actions and verification of their effectiveness.
  • Ideally, progress against significant issues should be reported within a specific timeframe.
  • Also, re-audits should be scheduled to confirm that crucial remedial actions are completed for all major deficiencies.


Key Takeaway

  • Supplier quality audits offer an excellent opportunity to engage directly with supply chain elements in a meaningful way.
  • They allow manufacturers to gain crucial insights that focus on the reduction of risk exposure and improvement of quality levels.


But a successful audit is not the end of the qualification process. After finalising the contract, the compliance of the selected supplier(s) with the applicable requirements should be evaluated periodically.


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Resource Person: BARBARA PIROLA

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