Internal Process Audit

Internal Process Audit


Dr Kalpesh Parikh, Director


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


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


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


•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)


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


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


Quality and Information SecurityPDCA

Interested Parties

Q/S requirements & expectations

Establish MS

Monitor and review MS

Maintain & Improve MSImplement &

Operate MS

Development, Maint. and Improvement Cycle

Plan

Do

Check

ActInterested Parties

Managed Q/S


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)


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


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


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)


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


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.


• 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


• 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


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)


• 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


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


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


SHANTIKRUPAESTATES PVT LTD

Icons Who Trusted us

Hashmukh Shah Group

Government AgenciesUGC-AICTE-INFLIBNET-AMC

Government CorporationsGSFC-GIIC-GAIC-GIDC

GHB

Gujarat Housing

Board


Think TechknowlogicallyMSWH-new Generation ERP

Technology

KnowledgeLogic ownership

SolutionTechniqueTechknowlogical

Quality Seekers are

Too BUSY

to be SAD

Too POSITIVE to be DOUBTFUL

Too OPTIMISTIC to be FEARFUL

Too DETERMINED to be DEFEATED

Internal Process Audit

Business

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