Description

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Quality audits are an important element in implementing and maintaining an effective Quality Management System (QMS). Audits are one of the most powerful tools that management has to assure on effective QMS.

In this workshop, participants examine the various types of audits to understand their role. Internal quality audits (1st party) help a company evaluate itself. Customer/supplier audits (2ndparty) play a role in an effective supplier management program; your company could be the subject of the audit. Independent audits (3rd party) can help provide assurance about the health of a QMS.

This workshop provides the tools to establish and maintain an effective quality audit program for medical device manufacturing. The program includes the two major elements. Develop a plan to schedule, conduct, report, and close audits. Assign qualified people based on training, skill, and conflict of interest considerations. The workshop explains how to implement these quality audit program elements using examples and exercises that help develop the necessary skills.

Another important part of an audit program is responding to audit nonconformances. This includes correction, investigation, and corrective action. An effective audit program determines and eliminates the causes of the nonconformity, corrective action, to prevent recurrence. The workshop provides methods and exercises to for these important activities.

Management needs to understand the results from each audit type as part of Management Review. The workshop presentation should use statistical methodology to analyze quality audit reports. The workshop discusses the role of management review and helps identify the appropriate statistical methodologies for effective communication to management.

Learning Objectives:

• Learn the difference among the audit types
• Learn the difference among audit methods (system, product, process, etc.)
• Understand audit scheduling and methods to establish and update the schedule
• Recognize the role of auditor competency and how to determine it
• Recognize which audits an auditor could conduct and which ones to avoid
• Understand the role of correction and corrective action related to an audit nonconformance
• Develop an effective approach for reporting at Management Review

Who Will Benefit:

• Audit Manager
• Lead Auditors
• Audit Team Members
• Management Representative
• Quality Assurance Managers
• Quality Engineers
• Regulatory Affairs Managers
• Supplier Management and Purchasing
• Supplier Quality Engineers

Day 1 Schedule

Lecture 1: Audit requirements in QMS standards

• FDA QSR
• ISO 13485:2003
• ISO 13485:2016
• ISO 14971:2007 & EN ISO 14971:2012
• MDSAP
• ISO 19011:2011

Lecture 2: Setting Up the Audit Program

• Contents of the audit SOP
• Developing and maintaining the audit schedule
• Determining audit areas - process, procedure, or department
• Tracking audit findings to closure
• Documenting corrective action
• Scheduling re-audits

Lecture 3: Auditor Qualifications and Assignment

• Determine auditor competence requirements
• Qualifying auditors - Training and experience
• Assigning auditors - Skill and knowledge
• Assigning auditors - Avoiding conflicts of assignment
• Evaluating auditor performance

Lecture 4: Planning the Audit

• Auditor assignment
• Audit scope
• Audit criteria
• Audit plan

Lecture 5: Conducting the Audit

• Audit methods
• The backward tracing process audit
• Reviewing records
• Interviewing
• Quality policy and quality objectives
• Collecting audit evidence

Lecture 6: Audit Sampling Plans

• Judgement samples
• Statistical samples
• Common statistical sampling plans

Lecture 7: Reporting the Audit

• Writing findings - positive and negative
• Scoring audits - Using the MDSAP method
• Writing audit conclusions
• The role of the audit report

Day 2 Schedule

Lecture 1: Conducting Second Party Audits

• Preparing for the audit
• Logistics
• Audit scope
• Performing the audit
• Writing the audit report
• Documenting the need for corrective action

Lecture 2: Being Audited (2nd and 3rd party)

• Customer audits
• Notified Body audits
• EU Unannounced audit program
• MDSAP
• FDA Inspections

Lecture 3: Responding to audit nonconformances

• Determining the cause
• Extending the corrective action
• Changes - procedures and training
• Evaluating the impact of changes
• Determining effectiveness

Lecture 4: Reporting to Management Review

• Quality audit as a management tool
• Summarizing audit results
• Determining QMS effectiveness
• Determining any need for change
• Management Review agenda and report

Dan O'Leary

President, Ombu Enterprises 
 

Dan O'Leary is President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years' experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and certified by APICS in Resource Management.