Recertification Audit on2nd

March 2015
Auditor- Mohan Nikam –Known this
organization when we are in Bhosari

"Quality is never an accident; it is always the result of high intention, sincere

effort, intelligent direction and skillful execution; it represents the wise choice of
many alternatives."
- William A. Foster
Highlight 2 Mindsets before audit:

1. You are God to Own your business(Ownership)

2. Know what you know, and know what you don't know (SWOT)
 Progression of Quality System
Documentation -4.2.2
Defines
INTERNATIONAL STANDARD international
ISO 9001 quality system
requirements

SECTOR REQUIREMENTS International

automotive
ISO/TS 16949 quality system
Part and Process Approval requirements
Procedures
Customer-
related
Company-specific requirements quality system
Auto sector requirements
Reference Manuals Level 1 Quality Manual
Defines approach and
APQP Quality responsibility including
manual assurance of customer needs
FMEA
Level 2
MSA Procedures
Defines
who, what, when
SPC
-P-PAP Level 3
Job instructions Answers
how
Level 4
Prompts recording
Other documentation of information
such as forms,
tags, labels
Comparison of the audit types:

ISO/TS audit is qualitative assessment

Process audit is measurable assessment

More Data & Detailed !

Think different

Audit Type Audit Subject Purpose

System Audit Quality system Assessment of the
completeness and effectiveness
of the basic requirements

Process audit Product development Assessment of the quality

process/serial production capability for specific products
Service development process/ /product groups and their
Providing the service processes

Product audit Products of services Assessment of quality

characteristics
• What is Process
EFFECTIVENESS
EFFECTIVENESS
PROCEDURE* OF
OFPROCESS
PROCESS==
Ability
Abilitytotoachieve
(“Specified way to carry out an activity or a desired
achieve
desiredresults
results
process” - may be documented or not) (Focus
(FocusofofISOISO
9001:2008)
9001:2000)

Input PROCESS Output

(“Set of interrelated
PRODUCT
(Includes
Resources) or interacting activities”) (“Result of a
process”)

EFFICIENCY
EFFICIENCYOF OF
MONITORING AND PROCESS
PROCESS==
MEASUREMENT OPPORTUNITIES Results
Resultsachieved
achieved
vs
vs resourcesused
resources used
(Before, during and after the process) (Focus
(FocusofofISO
ISO
9004:2008)
9004:2000)
* Note – This is the definition of “procedure” given in ISO 9000:2005.
This does not necessarily mean one of the 6
“documented procedures” required by ISO 9001:2008
• Audit Plan acceptable
• Audit may 2 or three days 2nd or 3rd
• Turtle diagram ?
• Quality Objectives?
• Feb 2014 performance can be asked during the audit
• Records availability
• Level2 level3 level4
• Calibrations
• Tagging ( Sufficient Stock available ?)
• NC product identified by tag & marking ( Red Paint ?)
• NC action Plan
• Set up approval
• Lights availability
• Five S
• No Leakages
• All NC closed -Aug 2014 &dec2014
• Two MRM :
• Sample audit
• Major NC & Minor NC & OFI
• Audit areas identified
• Chairs availability
• Any questions
Execute Process Audit(Highlight)

1. Check last audit report, management review report and CAPA(8D) ---To know
overall management level and process capacity expectation
2. Aftersales service data and customer satisfaction performance review ( How to
analyze these data and feedback them to Marketing, R&D and Process owner by
process?---VOC for DFMEA, an typical Process COPC company for customer
satisfaction/CRM)
3. Analyze Value Stream Map(VSM) to know process bottleneck and CIP
4. Analyze Process flow chart and Process control plan(analyze WBS for PS)
5. Typical 2 or 3 products APQP and PPAP review
6. Respect, Time, Patience , Fact, Communication and Result
7. Balance listening and question during audit
8. Balance conflicted process capacity, resource, priority, and interaction of related
processes to optimize system