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7/31/2019 Auditor Training Program
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INTERNAL AUDITORS
TRAINING PROGRAM
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OBJECTIVES :
UNDERSTANDQUALITY MANAGEMENT PRINCIPLES
ISO 9001 REQUIREMENTS
QUALITY SYSTEM DOCUMENTATION
AUDIT PROCESS AND CONDUCT
HAVE PRACTISEDPLANNING / PREPARING FOR AN AUDIT
CONDUCTING AN AUDIT INTERVIEW
RAISING NON-CONFORMITIESREPORTING AUDIT FINDINGS
HAVE RECEIVEDCONTINUOUS ASSESSMENT
PERFORMANCE RATING / CERTIFICATION
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COURSE EXAMINATION
Duration - 90 Minutes
Objective Type - 30 x 1.5 = 45
Audit Test - 3 x 10 = 30
Continual Assessment - = 25
Total = 100
Minimum marks for Pass = 80
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WHAT IS QUALITY ?
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FITNESS FOR PURPOSECONFORMANCE TO SPECIFICATION
VALUE FOR MONEY
CUSTOMER SATISFACTION / CUSTOMER DELIGHT
DOING IT RIGHT THE FIRST TIME AND EVERY TIME
JUST IN TIME
REDUCTION OF VARIABILITY
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The degree to which a set of inherent characteristics
(distinguishing feature) fulfils requirements. (need or
expectation that is stated, generally implied or obligatory).
( AS PER ISO 9000-2000)
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INSPECTION
Conformity evaluation by observation and judgementaccompanied as appropriate by measurement, testing or
gauging.
QUALITY CONTROL (QC)
Part of Quality Management focused on fulfilling Quality
requirements.
QUALITY ASSURANCE (QA)
Part of Quality Management focused on providing confidence
that the Quality requirements will be fulfilled.
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QC QA QMS
DETECTION PREVENTION DIRECTION
CODES &
STANDARDS ISO 9001/2/31987 - 2000
ISO9001 -2000
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Standardization originated in US during the II World war.
MIL-Q-9858 - Quality system specification.
MIL-I-45208 - Inspection system requirements.
NATO uses MIL standards as basis to form AQAP ( Allied Quality
Assurance Publication
AQAP-1 - Quality system specification.
AQAP-4 - Mfg. , Inspection & Test specification
AQAP-9 - Final Inspection specification
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UK does not accept AQAP and develops DEFSTAN (DefenceStandards) on its own.
Later, AQAP were aligned with DEFSTAN. DEFSTAN turns obsolete.AQAPs were very militaristic in their content. Within industry atlarge, there was need for common Quality standards. As a result
BS4891 & BS 5179 were born. These spelt out the codes of
practice, but had no application of contractual situations.
In 1979, BS 5750 was made. The First version of BS 5750 was notonly used in a contractual sense between buyer and seller but
BS introduced a third party registration scheme whereby they,
as an independent organization, registered companiescomplying with the requirements of the standard on behalf of
the customers.
Contd.
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As the need for such standardization was felt throughout theworld, an International committee was formed under the
chairmanship of Canada, to produce an International Qualitystandard. This committee was called International Organizationfor Standardization.
They considered many national inputs and in 1987 produced a
series of standards and this standards were called ISO 9000.
International Organization for standardization (ISO) located atGeneva, Switzerland is the approved body for issue andguidance of international standards today.
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Requirement for Global export / tender.
Requirement for supplies to large indigenouscompanies.
Decisive edge over competition.
Is an effective marketing strategy.Formal bench mark to improve effectiveness
Acquire new customers
Improved overall productivity & profit
Less Field failures, reduction in scrap and rework.
Employee Job satisfaction.
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ISO 9000 describes fundamentals of QualityManagement systems and specifies the terminology forQMS.
ISO 9001 specifies requirements for a QMS where an
organization needs to demonstrate its ability to provideproducts that fulfill customer and applicable regulatoryrequirements and aims to enhance customersatisfaction.
ISO 9004 provides guidelines that consider both theeffectiveness and efficiency of the QMS.
ISO 19011 provides guidance on auditing Quality andenvironmental management system.
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Quality Loop involves all phases right from initial identification to
customer satisfaction.
Product Quality is the resultant of the work of all the functional
departments
Each department has to carryout certain Quality related activities along withthe function.
Business Development
Contracts
Engineering Design
Procurement
Planning
Inspection &TestingExecution
Installation
Commissioning
Servicing
Customer Satisfaction
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Triple Role Concept
Customer
Processor
Supplier
Our activities must be customer driven. All of our
people must understand who their customers are andwhat their customers expect, regardless of whether
those customers are internal are external
- John Creedon, President, Metropolitan life
Supplier
Processor of
the
operation
Customer
Processor of
the Design
Customer Supplier
Processor of the
Construction
Supplier Customer
Requirements
Facility
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PROCESS :
CONTROLSe.g. Specs , Standards , Training
S
UP
P
L
I
E
R
I
N
P
U
T
INSTRUCTIONS
INFORMATION
MATERIALS
VALUE
ADDITION
PAYMENT
SALES
REPORT
O
U
T
P
U
T
C
US
T
O
M
E
RMECHANISMPEOPLE,TIME,EQUIPMENT,CONSUMABLES
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ACT PLAN
CHECK DO
Take corrective action,standardize & feed forward
to the next plan
Verify results of the
plan
Prepare Plan
Progress
Implement the plan ona small scale
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CUSTOMER
REQUIREMENTS
CUSTOMER
SATISFACTION
MANAGEMANT
RESPONSIBILITY
RESOURCE
MANAGEMENT
MEASUREMENT
ANALYSIS
IMPROVEMENT
PRODUCT
REALIZATION PRODUCT
PLAN
DO CHECK
ACT
PROCESS-BASED QUALITY MANAGEMENT SYSTEM
OUTPUT
VALUEADDING
ACTIVITIES INFORMATIONFLOW
CONTINUAL IMPROVEMENT OF QMS
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Quality
Manual
I
Quality
Procedures
II
WorkInstructions
III
Quality
Records
IV
Marke-
ting
Design Procur-
ement
Execu-
tion
QA Commi-
ssioning
Servici-
ng
Management / Customer Describes the Quality system inaccordance to Quality Policy
and ISO 9000 standards
Functional heads of
organization
Supervisors and
operators
Quality Assurance
Department
Describes the activities of
individual functional units
Describes the detail how a
specific activity is performed
Demonstrates the
performance of activity as
per the requirements of
standards
ISO QUALITY SYSTEM TRIANGLE
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ISO 9001-2000 PRINCIPLES &
REQUIREMENTS
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QMS :
MANAGEMENT SYSTEM ( COORDINATED ACTIVITIES )
TO DIRECT & CONTROL AN ORGANISATION WITHREGARDS TO QUALITY.
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1 . CUSTOMER FOCUS : UNDERSTAND CURRENT & FUTURE CUSTOMER NEEDS & MEET REQUIREMNTS
TRY TO EXCEED CUSTOMER EXPECTATIONS.
2 . LEADERSHIP LEADERS SHOULD CREATE & MAINTAIN INTERNAL ENVIRONMENT WHERE
PEOPLE INVOLVE FULLY & TRY TO ACHIVE ORGANISATIONS OBJECTIVES.
3. INVOLVEMENT OF PEOPLE PEOPLES FULL INVOLVEMENT ENABLES THEIR ABILITIES TO BE USED FOR THE
ORGANIASATIONS BENEFITS.
4 . PROCESS APPROACHMANAGE ACTIVITIES & RELATED RESOURCES AS PROCESS TO ACHIEVE
DESIRED RESULTS EFFICIENTLY.
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5. SYSTEM APPROACH TO MANAGEMENTACHIEVE EFFECTIVENESS & EFFICIENCY BY IDENTIFYING , UNDERSTANDING &
MANAGING INTERRELATED PROCESSES AS A SYSTEM.
6.CONTINUAL IMPROVEMENT : IMPROVING ORGANISATIONS OVERALL PERFORMANCE IS AN PERMANENT OBJECTIVE
7. FACTUAL APPROACH TO DECISION MAKING :ANALYSE DATA & INFORMATION TO MAKE EFFECTIVE DECISION
8. MUTUALLY BENEFICIAL SUPPLIER RELATIONSHIP ; BOTH ARE INTERDEPENDANT & CORDIAL RELATION BENEFITS BOTH
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ISO 9001 - 2000
1. SCOPE
2. NORMATIVE REFERENCE
3. TERMS & DEFINITIONS
4 . QUALITY MANAGEMENT SYSTEM
4.1 GENERAL REQUIREMENTS
4.2 DOCUMENTATION REQUIREMENTS
5 . MANAGEMENT RESPONSIBILITY
5.1 MANAGEMENT COMMITMENT5.2 CUSTOMER FOCUS
5.3 QUALITY POLICY
5.4 PLANNING
5.5 RESPONSIBILITY , AUTHORITY&
COMMUNICATION5.6 MANAGEMENT REVIEW
6 . RESOURCE MANAGEMENT
6.1 PROVISION OF RESOURSES
6.2 HUMAN RESOURSES
6.3 INFRASTRUCTURE
6.4 WORK ENVIRONMENT
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ISO 9001 - 2000 ( Contd )7 . PRODUCT REALISATION :
8. MEASUREMENT ANALYSIS &IMPROVEMENT
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AUDIT
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AUDIT
DEFINITION:
A SYSTEMATIC , INDEPENDENT & DOCUMENTED PROCESS FOROBTAINING EVIDENCE & EVALUATING IT OBJECTIVELY TO
DETERMINE THE EXTENT TO WHICH AGREED CRITERIA ARE
FULFILLED ( AS PER ISO 9000:2000 ).
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FIRST PARTY AUDIT
Conducted by, or on behalf of, the organization itself forinternal purposes.
SECOND PARTY AUDIT
Conducted by customers of the organization or by otherpersons on behalf of the Customer.
THIRD PARTY AUDIT
Conducted by external independent organizations,
usually accredited, provide certification or registration of
conformity with requirements such as ISO 9001.
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WHY INTERNAL AUDITS ?
WHAT ARE THE BENEFITS ?
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WHY TO AUDIT ?
Mandatory requirement of ISO 9000
Determining System conformity against aQuality System standard / procedures.
To determine the System effectiveness to
meet the objectives. To provide the Auditee with information to
use in improving the system.
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BENEFITS OF AUDITING
BUILDS CONFIDENCE IN MANAGEMENT
CONFIRMS QUALITY POLICY IS UNDERSTOOD & IMPLEMENTED IDENTIFIES SYSTEM DEFICIENCIES
ENABLE TO HIGHLIGHT SYSTEM WEAKNESS BEFORE POTENTIALPROBLEMS OCCURS
CONVENIENT FRAME WORK FOR INVESTIGATING PROBLEMS INPARTICULAR AREAS
ALLOW PERSONNEL FROM OTHER Depts AS AUDITORS TOKNOW HOW THEIR WORK AFFECTS OTHERS
CREATE OPPURTUNITY FOR INTERCHANGE OF IDEAS CREATES OPPURTUNITY FOR EXPRESSING NEW IDEAS FORIMPROVEMENT OF PROCESS IN COST EFFECTIVE MANNER
INCREASED COMMITMENT & MOTIVATION
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INTERNAL AUDIT
ISO 9001-2000 REQUIREMENTS
1 ) AUDITS ARE CONDUCTED AT PLANNED INTERVALS TO :* DETERMINE QUALITY MANAGEMENT SYSTEM
Conformity With PLANNED ARRANGEMENTS,
ISO 9001
POLICY & OBJECTIVES
EFFECTIVELY IMPLEMENTED
MAINTAINED
2 ) PLAN A PROGRAMME OF AUDITS , COVERING :
PROCESSES / AREAS TO BE AUDITED , CONSIDERING STATUS & IMPORTANCE
AUDIT HISTORY
3 ) DEFINE :
AUDIT CRITERIA & SCOPE
FREQUENCY & METHODS
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INTERNAL AUDIT
ISO 9001-2000 REQUIREMENTS
4 ) SELECT AUDITORS : OBJECTIVE
IMPARTIALTRAINED
5 ) DOCUMENTED PROCEDURE DEFINING :
PLANNING CONDUCTING AUDITS REPORTING
RECORDS
6 ) MANAGEMENT RESPONSIBILITY :
TAKE ACTIONS ( WITHOUT DELAY )
ELIMINATE NON CONFORMITY & THEIR CAUSES
7 ) FOLLOWUP ACTIVITIES SHALL :
VERIFY ACTION TAKEN ; REPORTING RESULTS
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ISO 19011 Guidance on auditing Quality and
environmental management system.
ISO 10011-1 AUDITING
ISO 10011-2 QUALIFICATION CRITERIA FOR AUDITORS
ISO 10011-3 MANAGING AN AUDIT PROGRAMME
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SCHEDULE
AUDIT
NOTIFY
PREPARE
ANALYSE
REPORT
FOLLOWUP
CORRECTIVE
ACTION
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SAMPLE FORMAT
PROJECT:
Month
Audited Area Date 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Audit No.
PLANNING
SURVEY
FABRICATION
PROCESS CONTROL
REINF. YARD
STORES
QC LAB
MR
Date Legend
Prepared by Next Rev. Holidays
QM-Dept. Audit Planned
Approved by MR Latest Rev. Audit performed
AUDIT CALENDAR
Jul-02
SAMPLE AUDIT NOTIFICATION
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SAMPLE AUDIT NOTIFICATIONLocation: CNRO Date: Sl No:
To: Section:
cc:
This notification is to advise that an Audit is scheduled to take place in your Site/Dept asdetailed below.
Please acknowledge receipt of this notification by signing and returning a copy of this form tothe MR ( R ).
AUDIT DETAILS:
Audit Number:
Date Planned:
Time:
Proposed Audit Scope:
The Auditor / Audit Team will be:The following personnel will be required to be available during the audit:
Approved by
Management Representative:(Region)
Signed:
Date:
Received by
(Title):
Signed:
Date:
Scope proposed Accepted by Auditee
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AUDIT PLANNING
IDENTIFY AUDIT SCOPE
Examine Relevant Documentation :
Manual / Procedures
Legislation / Specifications
Existing ChecklistsCorrective Action History
Prepare Itinerary Program :
Starting Time
Duration
Timetable
Closeout meeting
PREPARE
CHECK LISTS
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AUDIT CHECKLIST
PREPARE AUDIT CHECK LIST CONTAINING
THE QUESTIONS ON THE UNDERSTANDING OF
PROCESS
PROCESS STEPS
PROCESS CONTROLS
METHODS OF VERIFYING CONFORMANCE & EFFECTIVENESS
QUESTIONS
RECORDS
ACTIVITIES
DETAILS OF AUDIT TRAILS
AUDIT CHECKLIST
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Company : ABC Limited Dept : PURCHASING AUDITOR : XYZ Date : 23.04.02
QUESTION / TOPIC PROC. REF ADDRESSEE RESPONSE EVIDENCE
What is Purchasing department function Purchasing Mgr.
Where are relevant procedures are held? -do-
(check)
Review of requisitions Proc. WP 4.3.1 -do-
-Method
-Responsibility
What records are kept ? (Check) 3.1 -do-
Requistion log (Check) 3.2 -do-
Who maintains the preferred suppliers list? 3.3 -do-
(View and check issue)
-Method
Assessment of suppliers 3.4 -do-
-Method
-Frequency
Sample purchase orders (check against 3.5
requistions, log and supplier listing)
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AUDITORS - ROLE & RESPONSIBILITIES
REMAIN WITHIN THE SCOPE EXERCISE OBJECTIVITY
COLLECT & ANALYSE EVIDENCE
REMAIN ALERT FOR ANY INDICATIONS OF EVIDENCE THAT
INFLUENCE AUDIT RESULTS PREPARE FOR ANSWERING :
WHETHER THE PROCEDURES , DOCUMENTS DESCRIBING THE QSYSTEM KNOWN , AVAILABLE , UNDERSTOOD & USED BY
AUDITEE ?
WHETHER DOCUMENTS & OTHER INFO ARE ADEQUATE TOACHIEVE Q OBJECTIVES ?
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BE PATIENT
TRY TO KEEP TO YOUR PLAN
USE YOUR CHECKLIST
USE A NOTE BOOK AND TAKE GOOD NOTES
USE OTHER TEAM MEMBERS
EXPLAIN WHY YOU ARE THERE
BE AGGRESSIVE
CONDESCENDING
CLEVER IN HINDSIGHT
PASS INSTANT OPINIONS
BE LATE
BE SIDE TRACKED BY AUDITEE
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INTERVIEWING
SAMPLING
OBSERVATION
NOTE TAKING
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WHO - RESPONSIBILITIES
WHAT - INFORMATION
WHY - UNDERSTANDING
WHERE - LOCATIONS
WHEN - SEQUENCE
HOW - PROCESS
SHOW ME - COLLECT EVIDENCE
WHAT IF - TESTING THE SYSTEM
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OBSERVE CONSISTENTLY - DEVELOP AWARENESS HOUSE KEEPING
BODY LANGUAGE
FOLLOW VISUAL SIGNS LIKE SMILING , EYE CONTACT Etc.
BE A PEOPLE WATCHER COMMUNICATION CONSIST
WORDS WE USE 7 %
WORDS WE SAY 38 %
BODY LANGUAGE 55 %
COMMUNICATION SKILLS
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GENERAL SAMPLING METHODS
Auditors may sample
Departments
Procedures and work instructions
Processes / Equipment
People
Products & Records
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SAMPLING :
LET COMMONSENSE PREVAIL
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RECORD : ALL THE OBJECTIVE EVIDENCES
BE SELECTIVE IN RECORDING BOTH CONFORMANCES & NON
CONFORMANCES
NOTE RELEVANT TO AUDIT SCOPE DO IT OPENLY
DO NOT TRY TO REACH ON AGGREMENT ON INTERPRETATION
OF FACTS
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SIX STAGES OF AUDIT PROCESS
SET THE SCENE
CONFIRM BASICS
ESTABLISH THE PROCESS
CHECK BACK
CLOSEOUT
CHECK FOR
OBJECTIVE EVIDENCE
CYCLICAL
STAGES
COLLECT EVIDENCE BY
QUESTIONINGREVIEWING RECORDS
OBSERVING ACTIVITIESF
PUT THE AUDITEE AT EASE
HAVE SOME INFORMAL DISCUSSION
INFORM THE AUDITEE OF THE AUDIT PROCESS
DETERMINE :
ORGANISATION STRUCTURE
RESPONSIBILITIES
STATUS OF DOCUMENTATION
TRAINING & COMPETANCY OF PERSONEL
UNDERSTAND THE PROCESS BY:
IDENTIFYING PROCESS STEPS
By ASKING WHAT HAPPENS AT THE END
& VITAL WHEN DOCUMENTATION IS LIMITED
TO ESTABLISH HOW THE SYSTEM IS MANAGED ?
CONFIRM CONFORMANCE
ESTABLISH TRAILS
FOLLOW UP PREVIOUS TRAILS
EXPRESS APPRECIATION FOR COOPERATION
SUMMARISE FINDINGS
AGREE ON COMPLETION DATE
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NON CONFORMANCE
A NON FULFILMENT OF A REQUIREMENT
QUALITY MANAGEMENT SYSTEM
ISO 9001 : 2000
CUSTOMER SPECIFICATION
LEGISLATION
REGULATORY BODY
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GRADING OF NON CONFORMANCE
MAJOR
No evidence of adherence to a procedure or system
element
Or
Major risk to final product or service quality.
MINOR
Limited evidence of compliance with a procedure
Or
No appreciable risk to final product or service quality
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OBSERVATION
A STATEMENT OF FACT BASED ON EVIDENCE
INSTANCES OF BEST PRACTICES
INSIGNIFICANT PROBLEM SUSPISIOUS THAT NEED TRAILING
FEEDBACK TO THE AUDIT CONTROLLER
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NCR - REPORT REQUIREMENTS
NCR MUST CONTAIN
CLAUSE OF THE AUDIT STANDARD
PROCEDURE REFERENCE
LOCATIONACTIVITY
NATURE OF PROBLEM
EVIDENCE
SCALE OF PROBLEM ( MAJOR OR MINOR )
NON-CONFORMANCE REPORT (NCR)
LARSEN & TOUBRO LIMITEDRGEN 14 F 03-2
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Section Audited: MR FUNCTIONS
Auditor(s): Signature:
1 J Joseph Amalraj 1 -sd-
2 2
3 3
Audited Document:
Project Quality Plan No. VEC/PQP/025 Rev. 0 dtd. 07.01.02
Cl. 4.17 - Internal Audit
Non-conformance Statement:
INTERNAL AUDITS COMPLIANCE TO PLAN NOT EVIDENCED.
Objective Evidence:
SITE AUDITS FOR THE MONTHS MAY, JUNE, JULY HAVE
NO NCR'S / OBERVATIONS RECORD.
Auditee: Mr. N BALA MURUGAN
NCR Caegories(tick one) EN ISO 9002 Reference:
see reverse page Clause(s)
1 2 3 4 5 6
Signature: -sd- Date: 07.08.02
Remedial Action by auditee:
RECORDS OF SITE INTERNAL AUDITS WILL BEMAINTAINED FOR THE AUDITS CONDUCTED
Signature: -sd- completion target date:
13.08.02
Preventive action Proposed by auditee:
AUDIT PLAN Vs COMPLIANCE WILL BE REVIEWED DURING MANAGEMENT
REVIEW MEETING TO ENSURE COMPLIANCE
Auditee: Date:
Date:
Audit No: 05
NCR No: 30
Page 1of 2
4.17
Closing of NCR:
Auditor:
Signature:
Category Description
A A non-conformance situation that:
Can be easily corrected by auditee such as incorrect
1
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Can be easily corrected by auditee, such as incorrectcompletion of forms, or lack
of attention to detail in a number of occasions.
Generally does not require training of staff Can be corrected without cost to the Company
A nonconformance situation that;
Can be solved by the auditee, but may requireapproval from Manager
May necessitate training of staff Can be corrected without cost to the Company
A non-conformance situation that:
Can only be resolved through the issue of revisedprocedure text or content (not format) and associated
documents
Requires overview by QM Department (RO) tomaintain system integrity
May necessitate training of staff Can be solved with no or little cost to the Company
A non-conformance situation that:
Can only be resolved through the issue of revisedand/or delegation of procedure text
or content (not format) and associated documents
Can be solved by Site Manager but resolution mayhave wider business impact.
Requires overview by QM Department (RO) tomaintain system integrity.
Requires training of staff. Corrective action involves cost to the Company.
A non-conformance situation that:
Can only be resolved through the creation of anidentified procedure(s) and/or
associated documents
That can only be solved by Site Manager, butresolution may have wider business impact
Requires overview by RPM / RM to maintain systemintegrity
Requires the purchase of additional material orresources for its resolution
Requires training of staff Corrective action may cause significant costs to theCompany
A very serious non-conformance situation that:
Could affect the business and/or integrity of thesystem To be referred to RPM/ RM for further action.
5
6
2
3
4
CORRECTIVE ACTION
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CORRECTIVE ACTION
AUDITOR AUDITEENC IDENTIFIED
WRITE NCCONFIRM
NC
AGREE ON COMPLETION DATE
INVESTIGATE CAUSE
RECORD RESULTS
IDENTIFY CA
IMPLEMENTVERIFY
VERIFY CA TAKEN &
EFFECTIVENESSCLOSE NCR
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FOLLOW UP AUDITS
IT IS NECESSARY TO ENSURE THAT :
PROBLEM IS RECTIFIED & ELIMINATED COMPLETLY
EFFECTIVENESS IS DEMONSTRATED
CHECK BYASKING QUESTIONS
REVIEWING RECORDS
OBSERVING ACTIVITIES
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PERFORM AUDITINGPREPARE YOUR SELF FOR THE AUDITINGCONDUCT THE AUDIT AS PER THE GUIDELINES OF THE
TRAINEROTHERS OBSERVE THE AUDITINGDISCUSS WITH TRAINEE ON YOUR FINDINGS
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PREPARE NON CONFORMANCE REPORTS &SUMMARY OF AUDIT ON YOUR AUDIT
PRESENT YOUR FINDINGS ( EACH 10 MIN )DISCUSS WITH AUDIENCE
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COURSE REVIEW
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