Conducting a Successful Supplier Audit
Danielle DeLucy, MS, is currently an independent consultant to the
biologics and pharmaceutical industries specializing in the areas of
quality assurance and quality systems. Prior to this role, Ms. DeLucy
has been in the industry for 15 years serving in numerous quality
management roles, such as the director of product quality, the oversight
of sterility assurance practices, and provided QA oversight of numerous
filling and packaging operations. Ms. DeLucy began her QA career as a
quality control pharmaceutical microbiologist at Lancaster Laboratories,
a contract laboratory where she performed various tests for their
clients. In the years after, she has held positions in the quality
management arena while increasing her responsibility. She has helped
lead many regulatory health inspections and was instrumental in the
coaching process of her peers prior to any inspection. Currently, she
assists companies who are faced with warning letters and consent decrees
establish more robust quality systems so that the company can succeed.
When contemplating the use of a supplier you would normally have many requirements and expectations that must be met. These include technical, regulatory, quality, responsiveness, location, readiness, and those less defined but critical. One of the tools at your disposal to verify the supplier’s acceptability is to audit its operation. This webinar is designed to provide the participants a working knowledge of supplier audits. The why, when, who, how, and what of conducting a supplier audit will be reviewed to ensure that your supplier is capable of meeting all of your expectations. This is the first step in selecting the correct supplier to meet your outsourcing needs.
- Why audit your supplier?
- Who will audit your supplier?
- When will you audit your supplier?
- What will you audit?
- How will you conduct the audit?
- How to prepare a Pre-audit questionnaire
- Areas to be audited and using checklists
- How to conduct effective closeout meetings
- The advantages and disadvantages of using numerical audit scores
- Issuing observation reports and recommendations to your management and to your potential suppliers
Course Level - Intermediate
Who Should Attend
- QA staff and management
- Supply Chain representatives
- Regulatory Affairs staff and management
- Compliance auditors
Why Should You Attend
Many organizations conduct supplier audits because they are required to do so by their customers or a regulatory agency. Others conduct the audits because they have been led to believe that it's a good tool for comparing various suppliers against an arbitrary list of criteria. While all of these reasons have varying degrees of validity, none of them articulate the best reason for having a robust supplier audit program. A good supplier audit program should allow an organization to assess and periodically re-affirm the ability of key suppliers to provide conforming products consistently, reliably, and on-time. It should be one of the most important initiatives toward fulfilling the goal of having a sustainable supply chain.