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AUDITING An Overview Discussion Joel Schwartzman Retired. I am a retired. Certified Quality Auditor Certified Quality Engineer IATCA Senior Lead Auditor I was 6’7 ”. Candy and Gum manufacturers An Army Tank Plant

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slide1
AUDITING

An Overview Discussion

Joel Schwartzman

Retired

i am a retired
I am a retired
  • Certified Quality Auditor
  • Certified Quality Engineer
  • IATCA Senior Lead Auditor

I was

  • 6’7”
some of the companies i have audited are
Candy and Gum manufacturers

An Army Tank Plant

The company that makes car trunk openers

A manufacturer of $3000 drill bits

The engineering department for the NYC

subways

The largest aerosol valve manufacturer in the

world

Some of the companies I have audited are:
companies i audited cont d
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
slide5

More Companies (cont’d.)

  • A biotech manufacturing company
  • A toxicology lab
  • An aerosol filler
  • An auto dashboard manufacturer

ETC, ETC, ETC…………..

slide6
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.

what do all these have in common
What do all these have in common?

ALL HAVE QUALITY SYSTEMS

THAT MUST CONFORM TO A

SPECIFIC QUALITY STANDARD

THAT WAS AUDITED TO

the standard might have been
QS 9000

ISO 9000

TL 9000

GMPs for Drugs

GMPs for Foods

Industry Standards

Company SOPs

The standard might have been:
slide9
ISO 19011-2011 IS A

GUIDELINE DOCUMENT FOR

QUALITY MANAGEMENT

SYSTEMS AUDITING

slide10

ISO 17021 IS A NEW STANDARD

USED FOR

3RD PARTY CERTIFICATION AUDITS

audit purpose
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.
audit terms
Audit Terms:
  • 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.
audit objectives can be based on
Management priorities or system requirements

Statutory, regulatory and contractual requirements

A need for supplier evaluation

Risks to the organization

Whatever the boss dictates

Audit objectives can be based on:
audit program objectives may be designed to
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
general types of audits
General Types of Audits
  • System audit
  • Process audit
  • Product audit
auditors
AUDITORS

WHAT PERSONALITY TYPES

ARE AUDITORS?

auditor qualifications
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.)

must haves
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

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

Should Haves
should haves cont d
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

auditors should
Auditors should:
  • Remain with the audit scope
  • Collect and analyze evidence
  • Act in an ethical manner
auditors are responsible for
Auditors are responsible for:
  • Complying with the applicable audit requirements
  • Documenting and reporting audit results
  • Maintaining confidentially of the audit
audit planning
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
audit planning cont d
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.

interviewing techniques
Interviewing Techniques
  • Open ended questions
  • Probing
  • Silence
  • Pauses
  • Paraphrasing
variety of non verbal communication signals
Variety of Non Verbal Communication Signals
  • Facial expressions
  • Body movements
  • Vocal intonation and speech pattern

Often dictate the direction of the

conversation.

hidden communication factors
Hidden communication factors:
  • Hostility
  • Contempt
  • Concern
  • Anger
  • Fatigue
  • Boredom
  • Confusion
  • Apathy
communication barriers
Communication Barriers
  • Lateness
  • Unavailability of key people
  • Exceptions
  • Lack of time, resources
  • Long lunches
  • Interruptions
  • Amnesia
  • Lack of preparedness
communications during audit
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

the audit cont
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.

audit cont
Audit (cont)
  • Evidence is collected through

- Interviews

- Examination of documents

- Observation of activities and conditions

- Records

audit cont1
Audit (cont)
  • All observations should be:

- Documented

- Reviewed

- Reported as nonconformities

- Clear and Concise

- Supported by evidence

- Acknowledged by the auditee

audit cont2
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.

afterwards
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.
follow up
Follow-up
  • Corrective Action Plan (CAP) is requested within 30 days from auditee
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