Internal Process Audit

1. Internal Process Audit
Internal Process Audit
Dr Kalpesh Parikh, Director

2. Internal Process Audit
What is Management System?
“Set of interrelated or interacting elements to establish
policy and objectives and to achieve those objectives”
H/W
S/W
Humanware
MS
IT Solution
Infrastructure
System

3. Internal Process Audit
What is Standard ?
A Written document detailing minimum features,
specifications and requirement of product.
These are required to
(a) Prescribe the minimum requirements for Quality
(b) Ensure safety of operations both for workmen and users
(c ) Promote interchangeability of the product.
(d) Achieve variation reduction

4. Internal Process Audit
Effectiveness
“producing or capable of producing desired effect”
“extent to which planned activities are realized and planned
results are achieved”
Efficiency
“Acting or Producing effectively with a minimum of waste,
expense, or unnecessary effort”
“Exhibiting high ratio of output to input”
“relationship between the result achieved and the resources
used”
Effectiveness and Efficiency

5. Internal Process Audit
•Creating Customer Value
•Understanding Core Competence
(profound knowledge of business)
•Involvement of People
•Total optimization of system
•Process Approach
•Factual Approach
•Organization and Personal Learning
(Knowledge)
•Agility (To react Change)
Management System Principles
•Focus on Social Value
•Visionary Leadership
•Involvement of People
•Collaboration with partners
•Autonomy (Empowerment)

6. Internal Process Audit
Management Commitment Planning of Product Realization
Customer Focus Identify Customer Requirements
Quality Policy Review Product Requirements
Quality Objective Customer Communication
Quality Planning Design/Development Planning
Responsibility & Authority Purchasing
Management Representative Product/Service Realization operations
Internal Communication Customer Satisfaction/Dissatisfaction
Quality Manual Internal Quality Audit
Documents & Records Control Measure Process Conformance
Management review Measure Product Conformance
Providing Resources Control of Non-Conformity
Assigning Skilled Personnel Analysis of Data
Facilities Plan for continual Improvement
Work Environment Corrective and Preventive Action
Elements of QMS

7. Internal Process Audit
PLAN: ESTABLISH THE OBJECTIVES AND PROCESSES
NECESSARY T O DELIVER RESULTS IN ACCORDANCE
WITH CUSTOMER REQUIREMENTS AND
THEORGANIZATION’S POLICIES.
DO: IMPLEMENTS THE PROCESSES.
CHECK: MONITOR AND MEASURE PROCESSES AND
PRODUCAT AGAINST POLICIES,
OBJECTIVES AND REQUIREMENTS FOR THE PRODUCT
AND REPORT THE RESULTS.
ACT: TAKE ACTIONS TO CONTINUALLY IMPROVE PROCESS
PERFORMANCE.
Plan-Do-Check-Act (PDCA) Methodology

8. Internal Process Audit
Quality and Information Security
PDCA
Interested
Parties
Q/S
requirem
ents &
expectati
ons
Establish
MS
Monitor and
review MS
Maintain &
Improve MSImplement &
Operate MS
Development,
Maint. and
Improvement
Cycle
Plan
Do
Check
Act
Interested
Parties
Managed
Q/S

9. Internal Process Audit
Management System
Policy & Objective. Organisation Structure.
Responsibility and Authority Matrix. Management Review.
Reference to Procedures
Level 2 – Procedure /
Department Manual (Tactical)
Refers to number of activities of each department. Inerface
between departments (What to Do)
Level 3 – Work Instruction
(Operational)
Detailed step by step activities taken up for each operation
(How to do)
Records are proof of activities carried out. It is used to
analyze how good they are performed.
Format helps to record the data in systematic and
comprehensive manner.
Level 4 – Record , Formats
and Reports
Level 1 - Apex Manual
(Startegic)

10. Internal Process Audit
AUDIT-Definition
“systematic, independent and documented
process of obtaining audit evidence and
evaluating it objectively to determine the extent
to which audit criteria are fulfilled”
ISO 9000:2000

11. Internal Process Audit
AUDIT-Purpose
• To determine the conformity
• to determine activity/results are as per plan
• To determine the effectiveness
• To provide opportunity to improve
• To meet statutory regulatory requirements
• For certification

12. Internal Process Audit
AUDIT-Benefit
• Give Confidence to Management
• Give Confidence to Customer
• Observe Operational Problems
• Provide opportunity for Improvement
• Provide feedback for CA/PA (Corrective Action /Preventive Action)

13. Internal Process Audit
AUDIT-Who and Frequency
Audit is done to find conformance to what you write and
what you are doing is same or not.
How Often
: 2 Times a year
: can be separate for
different departments
Who Should Do IA
: Person can’t audit his
own department
: Needs IA Training
SUGGESTED FORMAT

14. Internal Process Audit
AUDIT-Types
First Party Audit Internal Quality Audit done by staff
members of company.
Second Party
Audit
Company audits its supplier
Third Party Audit Certifying body conducts audit
Initial Audit By Certifying Body which leads to ISO
certification
Surveillance Audit By certifying body every six month
after certificate is issued.

15. Internal Process Audit
• ISO 9000 Standards
• Quality Manual
• Department Manual /
Procedure
• Earlier Audit notes/
Checklists
• NCRs of last Audits
• MRM Minutes
Outcome : Questions /
Points of the Audit
i.e Audit Checklist
AUDIT-Preparation
SUGGESTED FORMAT

16. Internal Process Audit
• Gathering the information
• Document Review
• Sample Records
• Observations
• Interview
• Opening Meeting and Closing Meeting
• Link to Apex/ Dept Apex, Operational Manual
• Auditor’s word is final in case of observed facts
• Write full details of observations
• Write Suggestion to Improve the system more effective &
Efficient (Value Addition)
AUDIT-Perform

17. Internal Process Audit
Major/Minor NC (Non Conformity)
• Left out part of ISO 9000 requirements
• Non Compliance with Legal/Statutory requirements
• Safety Violation
• Intention to Deceive customer
• Discuss each NCR (Non Conformity Report)
• Use only one Clause which is best fitted
• Each NCR should have only one non conformity
AUDIT-NCR (Non Conformity Report)

18. Internal Process Audit
• Audit Report with observations (use Standard Format)
• Write NCRs (use Standard Format)
• Give it to Respective Dept Head and MR (management
Representative)
• Closing of NCRs after verification of the reply/action.
AUDIT-Post Audit Activities

19. Internal Process Audit
Time Allocation
(1) Preparation 35% to 40%
(2) Conducting 40% to 50%
(3) Reporting 10% to 15%
(4) Follow-up 5% to 10%
AUDIT-Best Practices
“5 S Method”
1. Seiri – “Sort, Systematize or Simplify”
2. Seiton – “Straighten, Standardize”
3. Seiso – “Shine”
4. Seiketsu – “Sanitize”
5. Shitsuke – “Sustain”
Ps: “A fool with a tool is still a fool”
Full Proof System Vs Fool Proof System

20. Internal Process Audit
AUDIT-How to Face
•Process Audit and not Person’s Capability
Evaluation
•No Need to Justify the Process (unless it is
asked for)
• Compliance to the process is sought by
Auditor
• Confidence and Ownership (No Fault
Findings)
• Records, Precise Info and Basics of What
You Perform
• Do not give anything more (something not
asked for)
• Always take help of Superior, Subordinate
and colleagues
Communication Protocols
•Light & Polite to be elite
•No Fight to offer Delight
•Absorb all your
insecurity and irritations
•Harmonization
•Confidence Level

21. Internal Process Audit
SHANTIKRUPA
ESTATES PVT LTD
Icons Who Trusted us
Hashmukh
Shah
Group
Government Agencies
UGC-AICTE-INFLIBNET-AMC
Government Corporations
GSFC-GIIC-GAIC-GIDC
GHB
Gujarat
Housing
Board

22. Internal Process Audit
Think Techknowlogically
MSWH-new Generation ERP
Technology
KnowledgeLogic ownership
SolutionTechnique
Techknowlogical
Quality Seekers are
Too BUSY
to be SAD
Too POSITIVE
to be DOUBTFUL
Too OPTIMISTIC
to be FEARFUL
Too DETERMINED to be DEFEATED