Audit Definition & Objectives

AUDIT is “An unbiased examination and verification of a company's

corresponding records and supporting documents, externally or internally”

While QUALITY AUDIT means the process of systematic examination of a

quality system carried out by an internal or external quality auditor or an
audit team. It is an important part of organization's quality management
system.

It is a fact finding practice which is different from inspection which is

mainly a defect finding activity.
Purpose of Audit
The purpose of audit is to help determine if the organization complies
with the defined quality system processes and it is done by collecting
objective evidence of processes, assessing how successfully processes
have been implemented and judging the effectiveness of achieving any
defined target levels.

Characteristics of an Audit
 Systematic
 Independent
 Documented process
 Obtaining audit evidences
Audit Criteria
 Set of policies, procedures and requirements
 It is used as a reference against which audit evidence is
compared
Audit Evidence
 Records, statements of facts or other information, which are
relevant to the audit criteria and verifiable.
For and instance: training records, Supplier evaluation records,
signed contracts and email communication for information
sharing
Audit Findings & Conclusion
 Results of evaluation of the collected evidences against criteria.
 Outcome of audit, provided by audit team.

Audit Scope
 Boundaries of audit including physical locations, units, activities
and processes etc.
Types of Audit

Types of 3rd Party Audit

 Desktop/ Adequacy/ Documentation Audit

 Compliance/ Implementation Audit

 Surveillance Audit
Roles and Responsibilities
• Client:

 Defining the audit objective

 Finalizing the audit scope & audit criteria
 Providing resources for audit
 Furnishing all relevant information and evidences

• Auditor:

 Audit planning
 Finalizing audit team
 Audit execution
 Documenting audit findings, conclusion and reporting
 Follow up and verification of corrective actions on non-
conformances
 Audit Activities
Sr. # Activities Expected Outcomes
1 Finalizing audit objective, scope and criteria Audit boundaries & requirements
2 Audit Team Formation Team members list
3 Audit Planning Preparation Audit Plan
4 Audit Intimation to Auditee Audit date and other details
5 Opening Meeting Conduct Plan sharing
6 Conducting documentation review CARs, observations and report
7 Preparation of audit checklist Audit questions to be asked
8 Collecting audit evidences Findings
9 Make audit conclusions Final results
10 Audit reporting Conformances and Non-conformances
11 Closing Meeting Results sharing
Audit Process
Audit Planning
 Define audit objective, scope and criteria

 Establish the audit team

 Prepare the Audit Plan

 Conduct Document Review

 Prepare Audit Checklist

Audit Plan
Audit Plan
Audit 17th - 26th October,
XXX-Dep/IQA/F/Oct20xx/01 Audit date:
#: 20xx
Departments
Sr. Date Time Region Location Auditors Activities to be audited
to be Audited
Quality Policy
KPIs
Reviews on KPIs
Kaleem Ahmed (Company)
Standardization in Ufone
Opening Faisal Shahzad Company)
10 AM - 11 Tech
1 18-Oct-xx North F-10 Office meeting with Saleem Khan- QA
AM Deployment of QI
CTO Baddar Munir- QA
processes
Farjad Saif– QA
QA Structure in Ufone
Resource allocation for
QA
ISO 9001 based QA
Kaleem Ahmed (Company)
Manual, SOPs, KPIs,
F-10 OfficeCore Planning Baddar Munir - QA
2 18-Oct-xx 12 PM -2 PM North Quality Improvement
(NSSP) Sajid Ahmed
teams, ATPs, Related
(Department)
Records
ISO 9001 based QA
Faisal Shahzad Company) Manual, SOPs, KPIs,
Core Planning
3 18-Oct-xx 12 PM -2 PM North F-10 Office Saleem Khan- QA Quality Improvement
(INV)
Majeed Khan (Dep’t) teams, ATPs, Related
Records
Audit Performance
 Conduct Opening Meeting
 Audit team introduction
 Verification of audit plan
 Audit scope is verified
 Required support solicited
 Time of closing meeting shared

 Execute Audit
 Conducting interviews
 Checking records

 Conduct Closing Meeting

 Final report shared
 List of non-conformances
 Follow-up audit tentative plan sharing
Evidence Collection

Reviewing documents and

instructions

EVIDENCE
Conducting interviews
COLLECTION

Checking Records

Observing work activities

Questioning Technique
• Open-ended Questions
• Closed-end Questions
Type of
Description Examples
Question

 What is ur opinion on results?

It can lead to a wide range of
 Could you please tell me how
answers. It is used to seek
Open-Ended you process ur results?
auditee’s opinion and process
 How do you calibrate ur tools?
understanding of auditors
 How do u control ur documents?

 Is there any documented process

for calibration?
It is used to ascertain an
 Are the results within threshold?
opinion and is expected
Closed/ Direct  Does this fall under your
normally to be answered in
responsibility?
”Yes” or “No”.
 Do you check the dimensions as
per approved drawings?
Auditor’s points to remember
• Keep in mind that audit is an interviewing session not an
interrogation.

• Investigate a claim and admit acceptance.

• Keep neutral; do not disagree and argue.

• Nod in agreement to maintain dialogue.

• Do not be sarcastic and critical.

• Be specific and to-the-point

Types of Non-conformances- NCs

MAJOR NCs MINOR NCs

- Systematic absence of a complete - Are isolated incidences of a lapse

requirement of standard in
documentation or implementation
- A number of minor deviations from
same element of a standard
or slippages on documentation or
implementation of standard
requirements

OBSERVATIONS
Findings which cannot be related to the requirements of the standards regarding a
nonconformance and does not warrant even a minor deficiency. For example, auditee’s
attitude, employee’s motivation and HSE issues etc.
Audit Reporting
 Executive Summary

 Approach and Methodology

 Audit Findings

 List of Non-conformances (Major, Minor and Observations)

 Recommendations (CARs)

 Follow-up Audit Plan

Corrective Action Request
CORRECTIVE ACTION REQUEST
Section/Area/Department: Date:

Auditor: Auditee:

Reference Clause #: Type of finding:

 Major  Minor  Observation
DESCRIPTION OF FINDING

Finding:
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________

Standard Requirement:
_______________________________________________________________________________
_______________________________________________________________________________

Signature (Auditor): Signature (Auditee):

Date: Date:
INVESTIGATION AND CORRECTIVE ACTION

Root Cause of the Problem:

_______________________________________________________________________________
_______________________________________________________________________________

Proposed Corrective Action:

_______________________________________________________________________________
_______________________________________________________________________________

Responsible Person: Target Date:

Signature (Auditee): Date:
FOLLOW-UP OF CORRECTIVE ACTION

 Corrective Action verified & found satisfactory  Corrective Action not found satisfactory

Remarks:
_______________________________________________________________________________
_______________________________________________________________________________

Signature (Auditor/MR): Date:

 Corrective Action Request
CORRECTIVE ACTION REQUEST
Section/Area/Department: Date:
Final Test Bench 21/06/2010
Auditor: Auditee:
Naeem QC Engineer
Reference Clause #: Type of finding:
7.6  Major  Minor  Observation
DESCRIPTION OF FINDING

Finding:
One of the voltmeters, # 389000, used for the testing of generators at the final test bench of the main assembly shop was not
calibrated.

Standard Requirement:
The clause requires that all test equipment used for monitoring the quality or performance parameters shall be calibrated.

Signature (Auditor): Signature (Auditee):

Date: Date:

AVOID STATEMENTS BLAMING PEOPLE; BLAME THE SYSTEM !!

• Workshop Engineer did not know how to repair the generator set”
OR
• “The operator was not trained”
Follow-up Audit
 Conducted on planned intervals

 Verification on sampling basis

 Progress on highlighted CARs

 CARs closure