PRESENTATION ON

QUALITY AUDIT

Presented By:
Hemang Gosaliya (1960)
Nivya Thankappan (1969)
Dushyant Panchal (1970)
QUALITY SYSTEM AUDIT
• Definition
▫ An audit is a systematic and independent
examination to determine whether quality
activities and related results comply with
planned arrangements and whether these
arrangements are implemented effectively and
suitable to achieve objectives
QUALITY SYSTEM AUDIT-MAIN FEATURES
• A systematic evaluation
• Quality system documentation, specification & drawings
etc. provide basis for evaluation
• Quality audit is independent
• Audit determines whether
▫ The documentation meets the defined quality objective
▫ The activity performed are in conformity with documents
▫ The quality system is effective in meeting objectives
▫ Statutory and safety requirement are fulfilled
▫
OBJECTIVES
• General objectives
▫ Conformity
▫ Effectiveness
▫ Improvement
• Specific objectives
▫ Audit should be initiated:
1.Within a contractual framework
2.For the purpose of an internal organization
audit
PROCESS FLOW FOR AUDIT PROGRAMME

Plan
Act

Do
Check
AUDIT TEAMS
• Lead auditor
• Experts
• Auditor trainees or observers acceptable to
client, auditee and lead auditor
• Role of Client:
▫ Initiate, define the scope & receive audit reports
▫ Decide on follow-up action & inform the auditee
PURPOSES OF AUDIT
• Establish the adequacy & suitability of the system
• Determine the effectiveness of the system
• Afford opportunities for system analysis
• Aid problem-solving
• Facilitate decision-making
• Aid employee involvement
• Help in establishing the capability of process &
equipment
• Ensure meeting legal and statutory requirements
• Aid communication and facilitate training
TYPES OF QUALITY AUDIT
• First-party Audit
• Second-party Audit
• Third-party Audit
• System Audit
• Process Audit
• Product Audit
• Adequacy Audit
• Compliance Audit
•
QUALITY AUDIT:
PLANNING & PREPARATION
• Purpose and Scope
• Resources needed
▫ HR
▫ Office Facilities
▫ Logistics
• Appointment of Team Leader
• Adequacy Audit
• Preliminary Visit
• Calculation of the duration of Audit
• Team Composition
• Audit Schedule
▫ External
▫ Internal
•
QUALITY AUDIT:
PLANNING & PREPARATION (contd.)
• Notification of Audit
▫ External Audit
▫ Internal Audit
• Effective Auditee
• Pre-audit Stage
• Desired qualities in an Auditee
▫
▫
THE QUALITY AUDITOR
• Personal Attributes
▫ Communication, Power of Observation, Flexibility,
Perseverance, Objectivity, Decisiveness
• Professional Attributes
▫ Independence, Appearance, Punctuality, Preparedness,
Fairness, Integrity
• Technical Ability
▫ Knowledge of Technical Standards & Regulations, Quality &
Cost Analysis, Statistical & Diagnostic Techniques
• Professional Status
▫ Accreditation, Code of Ethics, Professional Expertise
▫
▫
AUDIT PERFORMANCE
• Pre-requisites for Auditors
• Important points
▫ Arrival of auditors
▫ Access to important documents
▫ Opening meeting between auditee and auditors
▫ Idea of size and layout of operation
▫ Introduction of audit team
▫ Restating purpose and scope of the audit to auditee
▫ Explaining of audit schedule
 Time to be spent for each activity
Identifying auditors
Identifying elements to be audited in each function
Time and place of closing meeting
•
AUDIT PERFORMANCE
▫ Escorting of audit team
▫ Local arrangements
▫ Confidentiality
▫ Audit will be done on sample basis and is subject to sampling
limitation
• Recording observations
• Most common non-conformities
▫ Quality policy, objectives and procedures are not disseminated
▫ Obsolete documents are not removed
▫ Location demarcation
▫ Calibration is not maintained
▫ No reject tag on
▫
AUDIT PERFORMANCE
• Private Meeting of Auditors
• Closing Meeting
▫ Objective
▫ Attendance
▫ Presentation of Summary
▫ Nature of Report
▫ Presentation of Report
▫ Duration of Meeting
▫ Recommendations
AUDIT CHECKLIST
• Types
•
1. Criteria Checklist
2.
Area audited : ______________ Date:__________________
3.
• Checklist Questions Response

1. 1.
Does the company have a work instruction  
to operate the machine?
2. How is the machine being cleaned and  
maintained?
3. Are personnel trained to use the  
machine?
4. How often is the equipment being  
calibrated and cleaned?

5. When is the last breakdown  

of the machine?
Are there any product being
2.Auditor’s Checklist
AUDIT CHECKLIST (contd.)
• Sources of Checklist
▫ Std codes, criteria documents,etc
▫ Auditees quality manual
▫ Operating procedures
▫ Previous records
▫ Customer complaints & corrective reports
▫ National or international regulatory requirements
▫ Design control, technical drgs, test methods, etc
▫ Raw material & finished product test results
• Advantages of Checklist
▫ Keeps auditors on track
▫ Objective evidence of audit
▫ Record for future reference
▫ Complete coverage of the areas of interest
AUDIT QUESTIONING TECHNIQUES
• Types of Questions:
1. Open-ended Questions
▫ Theme que
▫ Expansive que
▫ Opinionated que
▫ Investigative que
▫ Repetitive que
2.Close-ended Questions
▫ Loaded que
▫ Assumptive que
▫ Leading que
•

▫
• Audit Reporting
•
• Verifiability of Findings
•
• Inferences
•
• Format of Audit Report
•
• Reporting the Findings
AUDIT REPORT: AN EXAMPLE
No GMP.Ref Findings of IA Grading Location Auditee Auditor

1. 2.1.1 Production and QC Critical Human Abas Budi

departments are Resources
headed by the same
person
2. 4.3 Monitoring of Major or Warehouse Tuti May Lin
temperature in a Minor
warehouse

3 11.1 Inadequate control Major or Production Herman Ida

over sub-contractor Minor
Do not Report These
• Proprietary or confidential information
• Subjective statements not substantiated by objective
evidence/individual opinion
• Unrelated recommendations
• Minor non-conformities already corrected
• Trivial matters
• Statements reflecting emotions, prejudices or arguments
• Aspects neither discussed nor mentioned during the closing
meeting
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