Internal Audit Jun05

Internal Audit
(C)Copyrights - Yadav Measurements ,

Udaipur
05/02/16
INPUT
LABORATORY
DATA
DECISION
HEALTH, SAFETY
ENVIRONMENT
COMMERCE
05/02/16
(C)Copyrights - Yadav Measurements , Udaipur
METHODS OF EVALUATING THE

COMPETENCE
OF A LABORATORY
On the spot assessment
of by the technical
experts
05/02/16
Performance in
PT program
SPECTRUM OF LABORATORY ACCREDITATION

ASSESSMENT
PROCEDURES
PROFICIENCY
TESTING
PROGRAMME
RULES
SURVEILLANCE
EXAMINATION
OF QM
LABORATORY
ACCREDITATION
ACTIVITIES
T
ACCREDITATIN
CERTIFICATE
SCOPE
C
NABL NEWS
NABL
STANDARD REF.
MATERIAL
COMPENDIUM
TRAINING
ASSESSORS
MONITORING
EAL
WECC
WELAC
ILAC
APLAC
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INTERNATIONAL
LINKAGES
NIST
NVLAP
NAMAS
NATA
------
U.K. ACCREDITATION
SERVICES
WHAT IS QUALITY?
Deming
Good quality does not necessarily mean high quality. Instead it
means a predicable degree of uniformity and dependability at low
cost with a quality suited to the market.
ISO 8402:1994
The totality of characteristics of an entity that bear on its ability to
satisfy stated and implied needs.
Juran
Quality is fitness for purpose.
Quality is a product that meets the customers requirements
or expectations.
A quality product does the job at an economic price.
Suppliers of a product do not decide upon its quality, their
customers decide.
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Quality
Performance
Quality = -----------------
Expectation
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QUALITY MANAGEMENT SYSTEM

Quality Management
System
Manuals
Procedures
Reference
Standards
Records
Other
documents
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Identify customer
Requirements
Control operations
and activities
Record all relevant
information
Meet customer
Requirements
Cost of Poor Quality

Not doing right first time
Re-testing
Recall reports / Products
Lost Productivity
Loss of staff morale
Processing Complaints
Direct financial loss
Lost Business
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Quality Cost
Prevention Cost
(First Time Right)
Planning for system
Documentation
Training
Equipment Mgt.
Reviews
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Appraisal Cost
(Checking for first time right)
Internal and
External PT
Internal and
External
Audits
Degradation of quality with time
Innovation
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Innovation
Time
Continuously improved Quality
Innovation
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Innovation
Time
QUALITY ASSURANCE
All the planned and systematic activities implemented
within the quality system and demonstrated, as needed,
to provide adequate confidence that an entity will fulfil the
requirements for quality
To ensure that
Performance
Quality =
----------------Expectation
05/02/16
> 1
QUALITYASSURANCE:
All activities associated with the attainment of quality

Organizational structure, responsibilities and authorities
Staff recruitment, induction, training, work allocation,
development
Leadership, motivation and supervision
Documentation of procedures
Test method selection, development and validation
Equipment selection, management and calibration
Control of accommodation and environment
Control of consumable supplies and reference standards
Internal and external quality control
Reception, labeling, processing and storage of samples
Addressing complaints and other corrective actions
Recording and reporting test results
Accounting and administrative functions
Audits and Management Review and follow-up improvements
05/02/16
QUALITY CONTROL
Operational activities aimed at monitoring the quality of
products and services throughout the testing process, and at
identifying unsatisfactory performance.
Examples :
Use of reference standards or items
Replicate testing
Trend analysis
Inter-laboratory comparison trials
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QUALITY IMPROVEMENT
Quality improvement is like a race without a finish line
ISO/IEC 17025 and Accreditation are just the starting points
The benefits include :

Improved staff confidence and self- esteem
Improved client satisfaction
Easier and more consistent training
Fewer mistakes
More profits
Better business
05/02/16
IEC 17025:2005 New Clause

4.10 Improvement
The laboratory shall continually improve the
effectiveness of its management system through the use
of the
quality policy, quality objectives, audit results, analysis of data,
corrective and preventive actions and
management review.
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Quality Objective
S.M.A.R.T
TARGETE
D
STRATEGIC
ACHEIVABLE
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MEASURABL
E
RELEVANT
Improvement
The organization shall continually improve
the effectiveness of the quality
management system through the use of
Quality policy,
Quality objectives,
Audit results
Analysis of data,
Corrective and preventive actions
Management review.
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4.13 Clause of IEC17025

Management requirement
i.e INTERNAL AUDIT
Predetermined schedule
Comply with requirements of quality system
and ISO/IEC 17025
All elements of quality system
Trained and qualified personnel, independent
( conflict of interest)
Records maintained of audits findings and
corrective actions
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INTERNAL AUDITS
This is a requirement of ISO/IEC 17025
Management wants to discover any weakness in
the laboratorys systems as soon as possible
Managers use them as a policing function
Internal audits are a powerful management tool to
aid quality improvement
Internal audits verify the effectiveness of corrective
actions
05/02/16
General Principles of Auditing

The general principles of auditing include the following:
a) Audits are an effective management tool to examine activities
and processes. The result of an audit is information on which
management can act;
b) Objectivity, independence and systematic approach are core
principles, which are essential for conducting effective and
efficient audits;
c) Audits are authorized, and authority may result from the decision
of management, company policy, provisions of contract, the
audit client, legislation or regulation;
d) Audit programmes and audits are planned and managed to
ensure that they are conducted in an effective and consistent
manner and that the audit conclusions are credible;
e) Audits are conducted using established methods and techniques
to ensure that audit evidence and audit findings are relevant,
reliable and sufficient, such
that audit teams working
independently from one another will reach similar audit
conclusions;
05/02/16
General principles of auditing

f) The scope, objectives and audit criteria of each audit are
clearly defined and agreed prior to commencing the audit;
g) Audit team members and audit programme managers are
competent for the tasks they perform;
h) Audit team members act with due professional care and
adhere to a code of ethics which prescribes for example,
auditor behavior, integrity, confidentiality and other
attributes. Audit team members are free from bias and
conflict of interest throughout their activities;
i) The relationship between the audit team, auditee and the
audit client is one of confidentiality and discretion. Unless
required to do so by law, the audit team does not disclose
the contents of documents, the nature of any other
information obtained during the audit, or the final report, to
any third party, without the explicit approval of the audit
client and, where appropriate, the approval of the auditee.
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Requirements for Internal Audits

a) The laboratory has planned for audits in its quality system;
b) The laboratory has nominated a person, or persons, to be
responsible for conducting audits;
c) The procedures for auditing are documented;
d) The audits are actually carried out;
e) The audits are conducted in accordance with a preplanned
programme;
f) The results of audits are recorded;
g) Remedial action is initiated immediately by the laboratory to
correct all non-compliances identified in its quality system
within a reasonable time scale;and;
h) The remedial action is effective and completed promptly
05/02/16
Audit cycle
4
Follow up &
CA
1
Planning and
preparation
3
Reporting
results
2
Execution
Of Audit
The audit is considered to be complete only

when corrective actions have been taken & auditor has verified.
05/02/16
(C)Copyrights - Yadav Measurements ,

Udaipur
Audit & Role of Quality Manager

Quality Manager is the responsible person for
Planning of audit
Records of audit
Involvement of other experts to complete the audit
05/02/16
AUDIT PLANNING
List the activity you plan to audit
Determine the period you need to complete the audit
Ensure that each activity is covered.
Take the help of check list
Arrive at the total duration needed to complete the
audit
Identifying the persons to be used for auditing
Ensure their availability and properly coordinate with
individual(s) of the section to be audited
Decide to what extent sampling is to be done. Discuss
it with individuals or lab staff to be used for audit
05/02/16
Implementing the audit programme

a) Documenting and communicating the audit programme;
b) Co-ordinating and scheduling activities
c) Assigning auditors and audit teams;
d) Providing required resources to the audit team;
e) Conducting audits according to the audit programme;
f) Collating records of the audit activities;
g) Reviewing audit records;
h) Reviewing and distributing audit reports to the audit
client and other specified parties;
i) Performing audit follow-up.
05/02/16
NABL assessment Process
Pre-assessment team briefing

Opening meeting
Examination of laboratory
Final team meeting
Closing meeting
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NABL - Opening meeting
Introduction
Purpose & scope
Program
Any changes special arrangements
Confidentiality
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Audit methods
Interviewing staff
Examination of facilities
Observing activities
Reviewing documentation
Reviewing records and reports
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Examining equipment
List??
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What are key clauses?
05/02/16
Audit Management
Manage time
Stay on track
Record finding
Remain impartial and objective
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Questions
Ask open questions
Who
What
How
When
Where
Why
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Do not ask
Questions
Self answering
Compound
Trick questions
Confirm answers in between
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Human aspects
Listening skills
Focus on speaker
Avoid physical distraction
Reassure verbally
Maintain appropriate eye contact
Project appropriate body language
05/02/16
Human aspects
Reduce tension
Put auditee at ease
Appreciate good work
05/02/16
ESSENTIALS FOR AN AUDITOR

Knowledge of quality manual, laboratory procedures
and other documents
Knowledge of accreditation criteria
Knowledge of specific criteria
Dont involve individuals to audit their own work
05/02/16
CONDUCTING AUDIT
CONDUCTING AUDIT AND STILL BE FRIENDS
* DONT EXHIBIT YOUR SUPREMACY
* DONT TRY TO FIND OUT FAULTS
KNOWLEDGE
CONDUCT OF AUDIT
Remain calm, friendly
Examine all facts and than conclude
Explore option for correction
05/02/16
PERSONAL RELATIONS / PERSONAL ATTRIBUTES
Open mindedness
Maturity
Sound judgment
Analytical skill and tenacity (firmness)
Ability to understand complex operations from a broad
perspective
Ability to perceive situation in a realistic way
Ability to understand the role of individual units within overall
organization
Conducting internal audit is not :
*FAULTS FINDING
* TO EXHIBIT SUPREMACY OR KNOWLEDGE
05/02/16
Horizontal Audit
audit plan horizontal.doc
05/02/16
Vertical Audit
audit plan Vertical.doc
05/02/16
CONTENTS OF AUDIT REPORT

Name of audit officer
Date of audit
Areas audited
Details of aspects examined including sample number,
equipments with identification
Any non compliance observed
Categorization of noncompliance e.G. Major/minor
Corrective action agreed, time period for corrective
action
Date of confirmation of completion of corrective action
Signature of quality manager confirming that
corrective action has been completed
05/02/16
IDENTIFYING
NON-COMPIANCES
Non-compliances can be :
Related to the quality system
Related to technical activities
Failure to do some thing required
Difference between work practices and documented
instructions
05/02/16
CLASSIFYING
NON-COMPLIANCES
Major non-compliances
Absence of a procedure required by standard
Significant failure to implement a procedure
Direct effect on quality of results
All other non-compliances are minor
05/02/16
EXPRESSING NON-COMPLIANCES
Statements of non-compliances
must be
Non-blaming statements of fact
Based on recorded objective evidence
Directly related to specific documented requirement
05/02/16
Control of Nonconforming Work

Wrong results can be found in many ways.
Laboratory must control this nonconforming
work.
Two main aims:
prevents wrong results being sent to clients
Provides opportunities for improvement
Corrective actions must follow-up detection of

nonconforming work
05/02/16
Control of Nonconforming Work
Identification
Documentation
Segregation
Evaluation
Review and disposition
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Documentation of Nonconformity
Date nonconformity was detected
The quantity of nonconforming work
The significance of the nonconforming work in terms of
potential consequences
Disposition of the nonconforming work
Authority for disposition decision
05/02/16
Identification of Nonconformity
QC procedures
Calibration results
External assessments
Internal audits
Management review
Customer feedback
05/02/16
Summary
Laboratory must have procedures for dealing
with nonconforming work.
Procedure must must ensure identification,
documentation, evaluation and disposition.
Procedures must protect the client from wrong
results.
Responsibility for review and authority for
disposition must be established.
05/02/16
Corrective and Preventive action

Correction
Mistake in report corrected
Corrective action
Find the cause for mistake and ensuring that it does not occur in
future
Preventive action
Making the fool proof procedure to ensure that the problem does
not occur.
05/02/16
Corrective Action
Corrective actions focuses on fixing problems
that already exist.
Improvement is possible through corrective
action but it is costly and fragmented.
Preventive action focuses on doing something
before a problem occurs
Improvement is less costly
05/02/16
CORRECTIVE ACTION LOOP
Problem
Identified
Likely
Cause
Identified
Records &
Documents
Updated
YES
Corrective
Action
Effective?
NO
Corrective
Action Taken
05/02/16
Corrective
Action
Identified
Corrective and Preventive action form

Yadav Measurements Private
Limited, Udaipur
Corrective and Preventive
action
Initiation :-Internal Observation / Customer Complaints /
Feedback/ Internal audit
Specific calibration (If any) :Date of receipt (By Incharge) :
By:Date:-
Date:
Number:
(For use in case of internal audit)

Reference Standard : IEC 17025
Clause Number:
Reference Document:
Auditor:
Details of Observation / complaint :Root cause analysis :Comments & acceptance from concerned :By:Date:-
Corrective Action Decided

1)
2)
Resp.
Target Date
Actual completion
Preventive Action Decided

1)
2)
Resp.
Target Date
Actual completion
Closing / Follow up remarks :By:Monitoring Required :- Yes / No

Action
05/02/16
Date
Contents of audit report
Name of audit officer

Date of audit
Areas audited
Details of aspects examined including sample number,
equipments with identification
Any non compliance observed
Categorization of noncompliance e.g. Major/minor??
Corrective action agreed, time period for corrective action
Date of confirmation of completion of corrective action
Signature of quality manager confirming that corrective action has
been completed
Witness of tests / calibrations
05/02/16
Management reviews
The responsibility lies with senior management
Quality manager is responsible to prepare the
agenda
Quality manager is responsible for action taking
as decided by Management Review
NABL Visits
Importance of records of Internal Audit &
Management Review
05/02/16
Periodicity
Each lab area shall be internally audited at least once in
a year for all requirements of IEC 17025
Our initial recommendation
One internal audit before pre-assessment
Two internal audit between pre and final assessment
There on two audits per year
05/02/16

Internal Audit Jun05

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Internal Audit Jun05

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Internal Audit

(C)Copyrights - Yadav Measurements ,

(C)Copyrights - Yadav Measurements , Udaipur

METHODS OF EVALUATING THE

(C)Copyrights - Yadav Measurements , Udaipur

SPECTRUM OF LABORATORY ACCREDITATION

(C)Copyrights - Yadav Measurements , Udaipur

(C)Copyrights - Yadav Measurements , Udaipur

(C)Copyrights - Yadav Measurements , Udaipur

QUALITY MANAGEMENT SYSTEM

(C)Copyrights - Yadav Measurements , Udaipur

Cost of Poor Quality

Recall reports / Products

Loss of staff morale

Direct financial loss

(C)Copyrights - Yadav Measurements , Udaipur

Planning for system

(C)Copyrights - Yadav Measurements , Udaipur

Degradation of quality with time

(C)Copyrights - Yadav Measurements , Udaipur

Continuously improved Quality

(C)Copyrights - Yadav Measurements , Udaipur

(C)Copyrights - Yadav Measurements , Udaipur

All activities associated with the attainment of quality

(C)Copyrights - Yadav Measurements , Udaipur

(C)Copyrights - Yadav Measurements , Udaipur

The benefits include :

(C)Copyrights - Yadav Measurements , Udaipur

IEC 17025:2005 New Clause

(C)Copyrights - Yadav Measurements , Udaipur

(C)Copyrights - Yadav Measurements , Udaipur

(C)Copyrights - Yadav Measurements , Udaipur

4.13 Clause of IEC17025

(C)Copyrights - Yadav Measurements , Udaipur

(C)Copyrights - Yadav Measurements , Udaipur

General Principles of Auditing

(C)Copyrights - Yadav Measurements , Udaipur

General principles of auditing

(C)Copyrights - Yadav Measurements , Udaipur

Requirements for Internal Audits

(C)Copyrights - Yadav Measurements , Udaipur

The audit is considered to be complete only

(C)Copyrights - Yadav Measurements ,

Audit & Role of Quality Manager

(C)Copyrights - Yadav Measurements , Udaipur

(C)Copyrights - Yadav Measurements , Udaipur

Implementing the audit programme

(C)Copyrights - Yadav Measurements , Udaipur

NABL assessment Process

Pre-assessment team briefing

(C)Copyrights - Yadav Measurements , Udaipur

NABL - Opening meeting

(C)Copyrights - Yadav Measurements , Udaipur

(C)Copyrights - Yadav Measurements , Udaipur

(C)Copyrights - Yadav Measurements , Udaipur

What are key clauses?

(C)Copyrights - Yadav Measurements , Udaipur

(C)Copyrights - Yadav Measurements , Udaipur

(C)Copyrights - Yadav Measurements , Udaipur

Confirm answers in between

(C)Copyrights - Yadav Measurements , Udaipur

(C)Copyrights - Yadav Measurements , Udaipur