5. ISO 9001
1. CUSTOMER FOCUS
2. LEADERSHIP
8 MANAGEMENT PRINCIPLES
3. INVOLVEMENT OF PEOPLE
4. PROCESS APPROACH
5. SYSTEM APPROACH
6. CONTINUAL IMPROVEMENT
7. FACTUAL APPROACH
8. MUTUAL BENEFICIAL SUPPLIER RELATIONSHIPS
6. 6
LEVEL 1 - QUALITY MANUAL
1. Quality Policy
2. Quality Objectives
3. Requirement Standard
4. Other Statutory and Regulatory
Requirements
7. LEVEL 2 - QUALITY PROCEDURES
1. Control of Documents
2. Control of Records
3. Internal Quality Audits
4. Control of Non-conforming Products
5. Corrective Action
6. Preventive Action
7
8. 8
LEVEL 3 - QUALITY PLAN
1. Incoming Inspection Plan
2. In-Process Inspection Plan
3. Final Test Report/ Inspection Plan
4. Work Instruction
9. 9
LEVEL 4 - FORMS / FORMATS/RECORDS
1. Testing Report forms
2. Commissioning Report Forms
3. Inspection forms
4. Check Sheets/Check List
5. Miscellaneous Documentation Forms
10. 1. Management Review
2. Competence, Training and Awareness
3. Planning and Production
4. Review of Requirement Related to Product
5. Design and Development Input
10
23 MANDATORY RECORDS
11. 11
23 MANDATORY RECORDS
6. Design and Development Output
7. Design and Development Review
8. Design and Development Verification
9. Design and Development Validation
10. Control of Design and Development Changes
12. 12
23 MANDATORY RECORDS
11. Purchasing Process
12. Availability of Monitoring and Measuring
Equipment
13. Preservation of Product
14. Customer Property
15. Control of Monitoring and Measuring
Equipment
16. Standards used for Calibrating Monitoring and
Measuring Equipment
13. 13
23 MANDATORY RECORDS
17. Identify and Enable Calibration
18. Result of Calibration and Verification
19. Internal Audit
20. Monitoring and Measurement of Product
21. Control of Non-conforming Product
22. Corrective Action
23. Preventive Action
15. QA/QC Concepts
• Quality Assurance
Quality Assurance (or QA) covers all activities from
design, development, production, installation,
servicing and documentation.
16. QA/QC Concepts
• Quality Control
Quality control refers to the process,
– most often implemented in manufacturing,
– monitoring the quality of finished products through
statistical measures and
– an overall corporate commitment to producing
defect-free products.
17. QA/QC Concepts
• Organizational Level.
At the organizational level, QA activities ensure
that the program or organization is successful by
overseeing the system implementation necessary
for individual projects in the program, and making
sure activities have the resources they need to be
successful.
18. • Project Level (Design, Estimate and Initiation)
At the project level, QA activities support the success
of an individual project by ensuring that accurate
information is channeled to the right people at the
right time so that decisions can be made during
project implementation.
QA/QC Concepts
19. QA/QC Concepts
• Technical Level.
At the technical level, QA activities ensure that the
individual technical activities that generate,
process, or synthesize data (or other information)
for the decision process are performing within
accepted limits.
21. Roles of QA/QC Department
1. Verify that requirements are followed,
2. Verify that controlling and checking an activity have been
done,
3. Ensure that approved working methods are established,
4. Evaluate the reported principal causes of non-conformances;
5. Evaluate the effectiveness of corrective action, and
6. Determine where improvements are required
21
22. Quality Control
Role of Quality Controller includes:
1. monitoring,
2. Inspection,
3. reduction of variation,
4. elimination of known causes, and
22
23. Quality Assurance Quality Control
A systematic set of activities to
provide confidence that
requirements are established
The process by which quality is
compared with applicable
standards;
An activity that establishes and
evaluates the processes
An activity which verifies if the
product meets pre-defined
standards.
Helps establish processes. Implements the process.
Difference in responsibilities
23
24. Quality Assurance Quality Control
Sets up measurements
programs to evaluate
processes.
Verifies if specific attribute(s) are
in a specific product or service
specific product or service
Identifies weaknesses in
processes and improves
them.
Identifies defects for the primary
purpose of correcting the
defects.
Prevents the introduction of
issues or defects
Detects, reports and corrects
defects
Difference in responsibilities
24
25. Difference in responsibilities
Quality Assurance Quality Control
Evaluates whether quality
control is working for the
purpose of determining
weakness in the process.
Evaluates if the application is
working for the purpose of
determining defect in the
functionalities.
Improves the process that is
applied to multiple products.
Improves the development of a
specific product or service.
QA personnel should not
perform quality control unless
doing it to validate quality
control is working.
QC personnel may perform
quality assurance tasks if and
when required.
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33. 33
Quality Management Objectives
zero defect (no defects on project
hand-over)
identify and solve problems before
customer does
establish true quality control by
making quality “built in” and not
“inspected in”.
34. Why do we do this?
• For better efficiency,
• Fewer rejects,
• Reduce if not eliminate customer complaints,
• Improve customer relation
• Improve supplier relation.
• And to answer our slogan:
– Open Challenge Quick Response
35. 35
CUSTOMER COMPLAINTS
Piping work related problem
28%
Ducting work related Problem
20%
Equipment /Materials Related Problem
23%
Problem 4
15%
Problem 5
8%
Problem 6
4%
Problem 7
1.4%
Problem 8
0.6%
(Est. Repair Cost: Ph P 1.7M in Laguna Area)
36. 36
Cost of Quality
KEY: ADDED
COSTS
Lost Revenue
Dumping Costs
Future Costs (Reclaim/
Environment)
Transport
Unload Container, Bags,
Trucks etc Testing
Paperwork/Database
Future repercussions
Root Cause
Investigation
Repairs B & C
Non-Conforming QA HOLD SCRAP
B & C B & C
C
REPAIR
C
Quality Check
C
Conforming
C
Install
C C
To CustomerConforming
A
Non-Conforming
A
QA HOLD
A
STORAGE
A
SCRAP
A
Order Placed
A
Order Made
A
Delivery
B
Replacement
Order
B
Order Made
B
Delivery
B
Conforming
B
Install
B B
To CustomerField Testing
B
Conforming
NORMAL
COSTS
ADDED
COSTS
Lost Revenue
Dumping Costs
Future Costs (Reclaim/
Environment)