Auditing Management Systems - ISO 19011|High Technology Seminars & Webinars

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Auditing Management Systems - ISO 19011

Ben Marguglio

Why This Seminar:

Auditing is one of the most important means by which an enterprise evaluates itself and its suppliers. Auditing must be effective – i.e., it must identify any major issues on a timely basis and do so efficiently. This seminar is aimed at contributing to auditing effectiveness.

Audience:

This workshop is designed for auditing managers, auditing supervisors, auditors and auditors-in-training who have responsibility for managing and performing internal and supplier audits of management systems (i.e., quality, environmental, health and safety, security or any management system other than financial) and processes – in accordance with the requirements of any of the ISO management system standards and ASME/NQA-1.

Learning Outcomes:

Upon completion of the seminar, one will be able to:

· Understand auditing terminology;

· Understand the differences in the processes for internal, supplier and third party auditing;

· Understand the factors to be considered in establishing an integrated auditing system;

· Design and document an integrated auditing system;

· Develop an overall auditing plan for a given time period;

· Develop an individual audit plan recognizing

							    o  
							
							"Compliance-based" or "effectiveness-based" audit 
							objective;

							    o  
							
							"Risk-based" or "non-risk based" audit scope;

							    o  
							
							"System-based" / "program-based", 
							"performance-based" and/or

"results-based" data collection;

· Lead the performance of any individual audit, step-by-step, in detail, from the entrance meeting/pre-data collection meeting to the issuance of the audit report and entry of the findings and opportunities for improvement into the problem reporting and corrective action tracking system;

· Assess the effectiveness of the integrated auditing system.

Outline:

1. Management’s role in the auditing system

2. Differences among internal, supplier and third party auditing processes

3. Integrating the auditing process for all management systems, other than financial

4. Auditing as an independent activity, and as an element of enterprise self-assessment and defense in depth

5. Differences among 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 auditing system for a given time period

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

(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

(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 findings and opportunities for improvement into the problem reporting and corrective action tracking system

8. Metrics by which to evaluate audit system effectiveness

9. Periodic independent oversight of the audit system

Handouts:

· Copy of the visual aids and exercises used in the seminar

· Certificate of Completion, with 1.5 Continuing Education Units

Click here to register for the seminar.

Click here for our presenter's credentials.

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