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AUDITING

An Overview Discussion

Joel Schwartzman Retired

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I am a retired

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: 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

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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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A biotech manufacturing company

A toxicology lab An aerosol filler An auto dashboard manufacturer

ETC, ETC, ETC…………..

More Companies (cont’d.)

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THERE ARE A MILLION STORIES ASSOCIATED WITH ALL OF

THESE AUDITS

I might tell you some of these andI 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: 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

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: 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:

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 Haves1. 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 Haves1. 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