Human Error; Human Error Prevention; Human Error Reduction; Error; Human Performance; Human Performance Improvement;
Root Cause Analysis; Corrective Action; Process Improvement
Human Error; Human Error Prevention;
Human Error Reduction; Error; Human Performance; Human Performance Improvement;
Root Cause Analysis; Corrective Action;
Process Improvement
|
Auditing Management Systems - ISO 19011 |
|
|
Audience |
This seminar is designed for auditors-in-training, auditors, audit supervisors and audit managers who have responsibility for auditing management systems (e.g., quality, environmental, health and safety, and security management systems) - specifically to the requirements of ISO 19011. |
|
Learning Outcomes |
This seminar covers in detail (a) the considerations for establishing the overall audit system (b) the differences in the processes for internal audit, supplier audit and third party audit, and (c) in anticipation of the forthcoming revision to ISO 19011, the process for performing an individual audit of any management system, in addition to quality, environmental, health and safety management systems. Upon completion of this seminar, you'll be able to: • Use audit terminology; • Understand the differences among internal, supplier and third party auditing; • Understand the factors to be considered in establishing an audit system and in structuring the audit system for application to any other management system; • Establish the audit objective - "compliance-based" or "effectiveness-based"; • Establish the audit scope - "risk-based" or "non-risk based"; • Determine data collections techniques - "system-based" / "program-based", "performance-based" and "results-based"; • Perform and lead an audit, step-by-step, in detail; • Design, develop, implement and assess an audit system. |
|
Outline |
1. Management’s role in the audit program 2. Differences among internal, supplier and third party auditing processes 3. Integrating the processes for quality, environmental, health and safety (and security) auditing 4. Audit as an independent activity and as an element of enterprise self-assessment 5. Assessment, audit and surveillance a. Definitions of each b. Differences in terms of requirements, objectives and methods c. Benefits and cautions of each 6. Planning the overall audit program 7. Planning individual audits a. Selecting the audit subject b. Establishing the audit objectives (1) Effectiveness-based versus compliance-based (a) Definitions of each (b) Benefits and cautions of each (2) Considerations in a regulatory environment c. Establishing the audit scope (1) Risk-based versus non-risk-based (a) Definitions of each (b) Benefits and cautions of each (c) Risk identification methods (2) Considerations in a regulatory environment (3) Identifying the success factors for the processes within the audit scope d. Scheduling the audit / Scheduling considerations e. Selecting the audit team (1) Team constituency (a) Cross-functional competency (b) Audit process facilitator (2) Team member characteristics (a) Subject matter expertise (b) Audit process expertise (c) Objectivity and thoroughness (d) Ethics f. Preparing and issuing the documented Audit Plan g. Conducting the entrance / pre-data collection meeting h. Collecting the audit data (1) Program-based versus performance-based versus results-based (a) Definitions of each (b) Benefits and cautions of each (2) Benchmarking (3) Operating experience (4) Interviews and interviewing skills (5) Real time observations and observation skills (6) Records (7) Reports (8) Status of resolution of prior issues (9) Data sampling i. Analyzing audit data (1) Facts versus conclusions (2) Veracity of the “facts” (3) Addressing factual disagreement (4) Pulling the string” (5) “Rolling-up” related conditions (6) Analyzing audit data on a facility-wide basis – e.g., common cause analysis j. Reporting results during the audit k. Conducting the exit / post-data analysis meeting l. Preparing and issuing the documented Audit Report (1) Structure (2) Problem significance (3) Problem ownership (4) Timeliness m. Entering problems into the corrective action process 8. Periodic independent oversight of the audit program |
|
Handouts |
• Typical procedures
for quality and environmental auditing • Supplemental
reading materials |
|
|
|
