A brief presentation about Audit methods, Quality Audit and Roles and responsibilities of Audit participants.

1. Types of Quality audit
and
Roles and Responsibilities of Audit
Participants
By:
Ch./Mohamed Hassanin
1

2. Intended learning objectives (ILO’s):
1. What is Audit?
2. Auditor-Auditee Relationship.
3. Types of Audits.
4. Audit purpose.
5. Common elements with other Audits.
6. Roles and Responsibilities.
2

3. 1. What is Audit?
“Systematic, independent and documented process
for obtaining audit evidence and evaluating it
objectively to determine the extent to which audit
criteria are fulfilled”
3

4. Audit methods:
1- Product audit
2- Process audit
3- System audit
4- Desk audit (Document review):
4

5. Audit methods:
1- Product audit: an examination of a particular
product or service to evaluate whether it conforms
to requirements.
Specifications
Performance
standards
Customer
requirements
5

6. 1- Product audit (Cont.):
6
Product
audit
elements
audited
Packaging
Shipment
preparation
Protection
User
instructions
Product
characteristics
Product
performance
Customer
requirements

7. Audit methods (Cont.):
2- Process audit: is verification by evaluation of an
operation against predetermined standards to
measure conformance to these standards and
effectiveness of the instructions.
7
Defined requirements

8. 8
2- Process audit (Cont.):
Very focused and usually involves only one work crew.
Process
audit
• Time
• Accuracy
• Temperature
• Pressure
• Composition
• Responsiveness
• Component mixture

9. 3- System audit: that is conducted on a
management system.
9

10. 10
3- System audit (Cont.):
Everything
within the
system
Processes
Products
Services
Supporting
groups
Customer
services
Waste
management
Training

11. 11
3- System audit (Cont.):
Standards describe “What” must be done and left the
“How” to the organization being audited.
Audit criteria
GMP ISO standards Regulations

12. Audit methods (Cont.):
4- Desk audit (Document review):
- Is an audit of organization’s documents.
- It conducted prior to a process or system audit to
verify that documents meet standard’s requirements.
12

13. 2. Auditor-Auditee relationship:
13
Audit
classification
Internal
Audit
External
Audit

14. 3.Types of Audits:
14
Types of
Audit
Internal
Audit
1st Party
Audit
External
Audit
2nd Party
Audit
3rd Party
Audit

15. 1st Party Audit:
- Performed within organization to measure its
strengths and weaknesses against standard.
- Conducted by organization’s audit team or outsourced
auditors (Benefits).
- The audit team should be independent and the
conflict of interest should be avoided.
- Separate audit team or Trained audit team.
15

16. 2nd Party Audit:
- External audit that performed by a customer (or a
contracted organization on behalf of a customer)
on a supplier.
- More formal than 1st party as it could influence
the purchasing decision.
16

17. 3rd Party Audit:
- Performed by an audit organization independent
of the customer-supplier relationship and is free of
any conflict of interest.
17

18. 4. Audit purpose:
- Certification purposes (Certification and Accreditation).
- Performance Vs. Conformance audit.
- Follow-up audit.
18

19. 5. Common elements with other audits:
a) Purpose and scope “Why are we doing this?”
b) Document review.
c) Preparation for review (The interviewed, location, schedule).
d) On-site or remote data collection.
e) Formal audit report (Introduction, summary, findings and conclusion).
f) Audit follow-up.
19

20. By its nature, an audit can cause stress between
participants.
The more contentious the relationship between
participants,
The more difficult it will be to achieve compliance,
conformity or improvement.
20
6. Roles and Responsibilities:

21. 6. Roles and Responsibilities (Cont.):
The audit participants are:
21
Client
Audit
program
manger
Lead
auditor
Auditor
Auditee
Escort Coordinator

22. Client responsibilities:
1. Determines the need for an audit.
2. Determines the audit purpose and scope.
3. Address budget issues.
4. Attends the audit meetings.
5. Supports the audit initiatives.
22
6. Roles and Responsibilities (Cont.):

23. 23
Audit program manager responsibilities:
1. Assigns qualified auditors to audit schedule.
2. Ensures the availability of resources.
3. Creates, Distributes and maintains audit program schedule.
4. Monitors auditor performance and reports audit progress to
management.
5. Promotes ethical behavior between the involved participants.
6. Keeps and safeguards audit program information.
6. Roles and Responsibilities (Cont.):

24. 24
Lead auditor responsibilities:
1. Responsible for communication with Client, Auditor program
manager and Auditee representative.
2. Conduct audit process meetings.
3. Ensures that necessary resources are available to audit team.
4. Plans the audit and directs the audit team.
5. Resolves conflicts of interest or other personnel issues.
6. Prepare reports and ensures that are properly filled and safeguarded.
6. Roles and Responsibilities (Cont.):

25. 25
Auditor responsibilities:
1. Understand the purpose, scope and criteria of the audit.
2. Collect audit evidence for verification against audit criteria.
3. Attend audit meetings.
4. Report findings to the lead auditor.
5. Report conflicts of interest to the lead auditor.
6. Maintain confidentiality of the audit information.
6. Roles and Responsibilities (Cont.):

26. 26
Auditee responsibilities:
1. Coordinates the audit with the lead auditor.
2. Informs their employee of audit purpose and scope.
3. Provides adequate space and privacy for auditors.
4. Attend audit meetings.
5. Cooperates with auditors and provides access to areas included
in the audit scope.
6. Takes corrective actions on audit findings.
6. Roles and Responsibilities (Cont.):

27. 27