Professional Documents
Culture Documents
Supplier Assessments / Audits: Audit / Auditing
Supplier Assessments / Audits: Audit / Auditing
Supplier Assessments / Audits: Audit / Auditing
CONCEPT
HEIDELBERG
Supplier
Assessments / Audits
Dr.-I ng. Guenter Generlich
guenter@generlich.de
Audit / Auditing
1
Supplier Assessments / Audits
Assessment Goals
2
Supplier Assessments / Audits
Typical ?
* * *
“I don’t want to hear your problems,
I want to hear your solutions”
Acceptance
User Requirements
Testing
application
driven
Functional System
Design + Spec Testing
Technical Integration
Design + Spec Testing
technology
driven
Supplier Programs
Unit Testing
Developer Development
3
Supplier Assessments / Audits
• Standard packages
• Custom systems / bespoke solutions
• Customized / configurable systems
• Technology products
• Service providers
Types of Audits
4
Supplier Assessments / Audits
Joint Audits
Maturity Scale
5
Supplier Assessments / Audits
6
Supplier Assessments / Audits
Audit Planning
• Prerequisites
• Preparing for the Audit
• GAMP or PDA Technical Report 32
• Conducting the Audit
• After the Audit
• Audit Report
• Follow-up
PDA - ARC
Advantages Issues
• Highly professional contents • Less contact with supplier
• Cost savings • Relevant aspects covered?
• Immediately available
• Reliably suppliers
7
Supplier Assessments / Audits
Prerequisites
• Pre-work requirements
• Audit team selection
• Planning and scheduling
• Preparing tailored audit criteria
8
Supplier Assessments / Audits
Pre-Work Requirements
9
Supplier Assessments / Audits
Audit Team
10
Supplier Assessments / Audits
1. Quality System
2. Project Management
3. Methodology
4. Testing
5. Configuration Management
6. Manufacturing
7. Documentation and Records Management
8. Security
9. Training and Education
10. Maintenance
Computerized Systems Validation Supplier Assessment 21
Dr. Guenter Generlich
11
Supplier Assessments / Audits
24.1 Unit level testing? Y Unit level testing corresponds to the soft-
ware item testing. See procedure “Soft-
ware I tem Testing”, SI T002A.
24.2 I ntegration testing? Y I ntegration level testing is performed in
the test phase software item test. The
stepwise composition of system compo-
nents up to the complete system is inte-
grated into this test phase. See procedure
“Software I tem Testing” SI T02B and C.
24.3 System level testing? Y System level testing covers complete sys-
tem functionality, including system inter-
faces to other systems; it includes the test
phases "System Test" and "I nterface Test".
12
Supplier Assessments / Audits
13
Supplier Assessments / Audits
Content of Report
• Cover Page
• Assessment / Audit History
• Table of Contents
• Introduction: purpose, scope, team members
• Description of Suppliers Business
• Summary: key audit areas, key observations (+ & -)
• Response and Commitment
• List of Evidence: documents reviewed, referenced (no copies)
• Detailed Results: audit checklist
Computerized Systems Validation Supplier Assessment 27
Dr. Guenter Generlich
14
Supplier Assessments / Audits
15
Supplier Assessments / Audits
Postal Audits
16
Supplier Assessments / Audits
17
Supplier Assessments / Audits
Escrow Agreement
from http://www.webster.com/
18
Supplier Assessments / Audits
19
Supplier Assessments / Audits
20