AUDITING
An Overview Discussion
Joel Schwartzman
Retired
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I am a retired

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Certified Quality Auditor
Certified Quality Engineer
IATCA Senior Lead Auditor
I was

6’7”
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Some of the companies I have audited are:
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Candy and Gum manufacturers
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An Army Tank Plant
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The company that makes car trunk openers
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A manufacturer of $3000 drill bits
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The engineering department for the NYC
subways
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The largest aerosol valve manufacturer in the
world
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Companies I audited (cont’d):

The company that makes coin exchangers for
candy machines

A company that extracted seaweed for a
ingredient used in chocolate milk

Electronic component distributors and
warehouses

A telephone cable manufacturer
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More Companies (cont’d.)
A
biotech manufacturing company
 A toxicology lab
 An aerosol filler
 An auto dashboard manufacturer
ETC, ETC, ETC…………..
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THERE ARE A MILLION STORIES
ASSOCIATED WITH ALL OF
THESE AUDITS
I might tell you some of these
and
I might tell you where a good restaurant is
nearby.
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What do all these have in common?
ALL HAVE QUALITY SYSTEMS
THAT MUST CONFORM TO A
SPECIFIC QUALITY STANDARD
THAT WAS AUDITED TO
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The standard might have been:
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QS 9000
ISO 9000
TL 9000
GMPs for Drugs
GMPs for Foods
Industry Standards
Company SOPs
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ISO 19011-2011 IS A
GUIDELINE DOCUMENT FOR
QUALITY MANAGEMENT
SYSTEMS AUDITING
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ISO 17021 IS A NEW STANDARD
USED FOR
3RD PARTY CERTIFICATION AUDITS
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Audit Purpose

The purpose of quality auditing is to examine the
effectiveness of management directed control programs.

The philosophy of quality assurance programs is based
on prevention rather than detection of problems.
Audit Scope

To determine the areas of investigation that the audit
will encompass.
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Audit Terms:


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
Appraisal - A form of the quality system audit,
normally conducted to examine the quality
program effectiveness and implementation.
Audit - Planned and documented assessment
to determine whether requirements are met.
Audit Standard - Description of characteristics
that reflects current practice.
Auditee - An organization or person being
audited.
Auditor - Individual carrying out the audit
Client – Determines the scope and purpose of
the audit and receives the report.
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Audit objectives can be based on:

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Management priorities or system requirements
Statutory, regulatory and contractual
requirements
A need for supplier evaluation
Risks to the organization
Whatever the boss dictates
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Audit program objectives may be
designed to:

Evaluate and maintain confidence in a supplier

Verify conformance to contractual
requirements

Become certified to a management system

Follow up a corrective action program
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General Types of Audits

System audit

Process audit

Product audit
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AUDITORS
WHAT PERSONALITY TYPES
ARE AUDITORS?
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AUDITOR QUALIFICATIONS
For the first time in the USA, a new psychometric
test was part of the ISO certification process in
2005. (These same requirements should be
applied to all audits.)
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Must Haves
1. Ethical and Principled
Honest, truthful, sincere, discrete
2. Proactive and organized
Will take the initiative with issues
3. Systematic
Shows balanced affiliation for both tasks and
people
4. Logical
Makes decisions based on facts and reasoned
logic
5. Decisive
Will expedite decisions methodically
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Should Haves
1. Observant
Shows the ability to identify both patterns and
exceptions in complex systems
2. Diplomatic
Shows tact in appropriate situations
3. Flexible
Shows a balanced global and detail focus
4. Process Preference
Demonstrates the ability to follow a predetermined
method
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Should Haves (cont’d.)
5. People Sensitive
Distinguish and identify a person’s emotional state
and operating style
6. Adaptable and Resourceful
Match and work with different types of people in a
range of situations
7. Confident
Demonstrates calm and poise in challenging situation
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Auditors should:

Remain with the audit scope

Collect and analyze evidence

Act in an ethical manner
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Auditors are responsible for:

Complying with the applicable audit
requirements

Documenting and reporting audit results

Maintaining confidentially of the audit
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THE AUDIT
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Audit Planning

Establish the audit objectives

Plan resources needed

Select lead auditor and audit team

Develop an audit plan

Notify the auditee & obtain confirmation

Coordinate schedules with management

Determine time requirements
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Audit Planning (cont’d.)

Determine the critical areas to be audited

Plan resources needed

Determine time requirements

Track progress on action plans

Respond to new emphasis from FDA,
International regulations etc.
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THE QUESTIONS
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Interviewing Techniques

Open ended questions

Probing

Silence

Pauses

Paraphrasing
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Variety of Non Verbal
Communication Signals

Facial expressions

Body movements

Vocal intonation and speech pattern
Often dictate the direction of the
conversation.
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Hidden communication factors:
Hostility
 Contempt
 Concern
 Anger
 Fatigue
 Boredom
 Confusion
 Apathy

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Communication Barriers

Lateness

Unavailability of key people

Exceptions

Lack of time, resources

Long lunches

Interruptions

Amnesia

Lack of preparedness
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AUDIT LOGISTICS
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Communications During Audit

Opening meeting
- Introduce the audit team to the auditee
- Review the scope and objectives of the
audit
- Set the time and date for the closing
meeting
- Finalize the agenda
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The audit (cont)

Plant tour
This is a walk through the facility to
familiarize the audit team with the site.
During this walk through, information
concerning the raw material receipts,
storage, processing and quality control
inspections are reviewed with notes taken
concerning items to be reviewed further.
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Audit (cont)

Evidence is collected through
- Interviews
- Examination of documents
- Observation of activities and conditions
- Records
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Audit (cont)

All observations should be:
- Documented
- Reviewed
- Reported as nonconformities
- Clear and Concise
- Supported by evidence
- Acknowledged by the auditee
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Audit (cont)

Daily review
This gives the auditee an opportunity
to discuss and findings
Closing meeting
- Present observations to management
that will be incorporated into the report.
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Afterwards

The project is not finished until the
paperwork is completed.

For external audits, the expense report is
written first.

Audit Report is drafted within two weeks.
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Follow-up

Corrective Action Plan (CAP) is
requested within 30 days from auditee
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THAT’S ALL FOLKS
Biguy25103@aol.com
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