- Process Approach
- Where Audits are Conducted
- Read Less and Listen More (see excerpt below)
- Start at the End with Problems
- Focus on Effectiveness Checks
3. Read Less and Listen More
Most auditors like to start with a procedure and then look for compliance with the procedure. We start with an interview, then we ask for a demonstration and we ask for records and procedures last. In fact, I coach new auditors to ask people they are interviewing to show them where a requirement can be found in their procedure. This has several hidden benefits. First, auditors don’t have to spend a lot of time hunting for a requirement because the auditee will find it for the auditor. Second, the auditor will quickly learn how familiar the auditee is with the specific procedure. Finally, if the company is not following a procedure the auditee is unlikely to be able to find the requirement in their procedure.
Read the complete blog below:
Your Next Independent Audit
To schedule Medical Device Academy for a comprehensive, independent audit of your quality system to help ensure compliance with FDA or Notified Bodies, please contact Glenn Melvin, Director of Development, Medical Device Academy at 561-308-3093 firstname.lastname@example.org,
Robert Packard-QA/RA Expert
Rob Packard provides regulatory submissions (510k, CE Marking, etc.), compliance auditing and training services for medical device manufacturers.
He has 20+ years experience in the medical device, pharmaceutical and biotechnology industries.
From 2009-2012, he was a lead auditor and instructor for BSI. Rob’s specialty is regulatory submissions of high-risk medical devices for CE marking and Canadian medical device applications.
He founded the Medical Device Academy in 2012 as a consulting firm focused on helping medical device companies with regulatory submissions and ISO 13485 certification. The firm has grown to seven consultants in one year. The most favorite part of his job is training others.
Specialties: CE Marking, Canadian Medical Device Applications, Post-Marketing Activities, Supplier Quality, CAPA, Risk Management, Auditing, Sterilization Validation, Lean Manufacturing, Silicone Chemistry, Extrusion, Bioprocess Engineering, and Strategy.
Rob has authored 100+ blogs on a number of topics ranging from regulatory submissions to ISO 13485 certification to management review (http://bit.ly/MDA-Blog).