PRE AUDIT MEETING

1. Establish performed contact

2. Clearly under stand the objective,
3. Familiarize the lead auditor with auditee organization
4. Estimate the true required for audit.
5. Establish whether any other assessment have been performed recently.
6. Estimate for needs for specialized staff.
7. Arrange dates for the assessment
8. Discuss administration aspects, discuss potential problem areas.
9. Obtain current issues of the organization QA documentation.

CAPLIANCE
Check the implementation Three-month periods. External & Internal.

Internal audit can do extertial audit. Supplies to customer or customer to supplier

II nd party,
II nd party can done III rd party
III rd party can done independently (certification authority)

TEAM SELECTION
A-HACCP Hazards analyzes and control critical points.

1. Type of quality system standards. Continuing, capture, software, service standards.

2. Types of service or product and is regulatory requirement (Health care Foods in
durance, nuclear devices).
3. Need for professional qualification or Technical expertise in a particular discipline.
4. Need for still in managing the Team.
5. Ability to make effective use of the various audits team member.
6. Personnel bill needed to deal with particular auditee, Required language & bill, other
relevant factors.

QUALITY AUDIT
A check to find out halters the quality is Quality management system audit 4 stages.

Independent audit with evidence (Required evidence at the time of audit, criteria call it as
objective evidence Qualitative and Quantitative.

WHY DO AUDIT
1. Ensure compliance with standards.
2. Check of current status.
3. Facilitate the improvement.
4. Enhance Quality awareness.
5. Increase Inter departmental understanding.
 (QUALITY AND AUDITING)

AUDIT TYPES

Compliance

Adequacy

1 Third party Independent - External

2 Second party by customer/supplier - Internal

3 First party by company – internal

ADEQUECY
Document Review (Friendly – useful auditing). The document should in simple language.

DESK AUDIT
1. At a leisure time can audit all expence will save.

ADEQUCY AUDIT DESK & ANSITE

Sectionalized documents
(Need to No bares) – Relevant cesium

External Documents – Stars, Codes, Certificates

Verification – Before starting production
Validation – during & after – the customers. Requirements.
Quality service – Flexibility – Rating

TRACEBILITY
Documentation
Correction action Identification
CA Prevention action Notification
Correction Evaluation
Segregation and
Disposal.

The Clauses for the Mandatory Procedure

5 1 2 3 4 6
4.2.3, 4.2.4, 8.2.3, 8.3 8.5.2, 8.5.3

Mandatory Record 27

Develop process Establish, Processes or similar sounding words.

C - Central management
L -
I -
P -
S -
C
I - Continue of Improvement

F
A - Factual Approach
S

Find out all processes maintained by the company/organization then audit?

Quality audit – Other Auditing
Fact Finding – Fault finding

ISO 9000 Certification Terminology

Fran NABAT – Acriditation

1. BVQCI
2. DNV
3. TUV

STQC Standard Testing & QC

ACCRE DITATION
The formal reorganization agreement published criteria of the competence and impartially of a
certification body.

IS 10201 – part 1, 2, 3 Quality Management System

IS 14001 –part 2, 3 – Environment systems.

CERTIFICATION/REGISTRATION

DTI – Directorate of Trading Industry

IQA

IRCA

EDIMB- Establish, Document, Implement & maintenance

Document 1. Quality policy manual

Procedure 2. Quality objection
Document Records 3. Work Instruction
Document Format 4. Documents, Records Forms

P1 p2 p3 p4
Level 1 – QP/QO
Level 2 – Q manual
Level 3 – procedure manual
Level 4 – Work aids
Level 5 – Formats

CONTROL
1. What ‘s to be control
2. Who will control
3. How is going to control

Issue
Education Whole documents Revision Amendments
Release
 System approach to management
 Continual improvements
 Try to found out the variation and to try to reduce
 Factual approach to decision making (Fact on Fact)

Customer is the recipient of the product

Supplier Organization Customer

LA 8
Why the paradigm shifts from quality Assurance to quality management System?

LA 9
What is ISO
Acronym for International Organization for Standardization.

LA 11
How was ISO 9000 developed?

ISO 9000 – BS 5750

Benefit of ISO 9000
INTRINSIC
1. Competitiveness through cast Request ion by eliminable of waste, Rework Scrap.
2. Improvable efficiency, productivity and house keeping
3. Improved employee morale resulting in teem building
4. Improved communication and quality of information
5. Increased customer confidence.

EXTRINSIC
1. World wide Reorganization and credibility
2. Access to world markets
3. Qualification to bid and new contracts
4. Improved corporate quality image
5. Tool for motivating suppliers to conform
6. Reduction in customer audit.