Quality & Environmental Auditing – ISO 19011 
BW (Ben) Marguglio; President; BW (Ben) Marguglio, LLC

Audience

This seminar is designed for quality and environmental auditors-in-training, auditors, and audit supervisors and managers who have responsibility for the internal and supplier quality audit processes – specifically to the requirements of ISO 19011.

Learning Outcomes

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

• Understand and use quality and environmental audit terminology;

• Use a “compliance-based” or “effectiveness-based” audit objective, a “risk-based” or non-risk based audit scope, and "system-based”/ “program-based”, “performance-based” and “results-based” data collection techniques;

• Perform and lead internal and supplier quality and environmental audits;

• Design, develop and implement internal and supplier quality and environmental audit processes;

• Manage or assess such processes.

Outline

1.   Management’s role in the audit program

2.   Audit as an independent activity and as an element of enterprise self-assessment

3.   Assessment, audit and surveillance

      a.  Definitions of each

b.  Differences in terms of requirements, objectives and methods

c.  Benefits and cautions of each

4.   Planning the overall audit program

5.   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

6.   Periodic independent oversight of the audit program

Handouts

• Typical procedures for quality and environmental auditing
• Copy of the visual aids
• Copy of exercise materials

• Supplemental reading materials
• Certificate of Completion, with Continuing Education Units

Click here to register for the “Quality & Environmental Auditing” Seminar

Click here for Ben Marguglio’s credentials