Quality Management

1. E M B 4 4 4 3 Q U A L I T Y
M A N A G E M E N T
Q U A L I T Y C O N T R O L
M A N A G E M E N T
Dr. Nurhasyimah Abd Aziz

2. Q U A L I T Y P L A N N I N G / Q A / Q C
QUALITY ASSURANCE (QA)
• QA applies to a process. It is set of activities
designed to ensure that the development
and/or maintenance process is adequate to
ensure a system will meet its objective.
• Reviews, preferably by independent third
parties, are performed upon a completed
inventory following the implementation of QC
procedures.
• Reviews verify that measurable objectives (data
quality objectives, were met, ensure that the
inventory represents the best possible estimates
and support the effectiveness of the QC
programme.
QUALITY PLANNING
In the Planning Process, the aim is to
determine the standards that are relevant for
the Product, the Organization and the means
to achieve them

3. QUALITY CONTROL (QC)
• Quality Control (QC) applies to a product. It is a
set of activities designed to evaluate a
developed a work product.
• QC system is designed to:
i. Provide routine and consistent checks to
ensure data integrity, correctness, and
completeness;
ii. Identify and address errors;
iii. Document and archive inventory material
and record all QC activities.
QC
Activities
Check on
data
acquisitions
&
calculations
Use of
approved
standardized
procedures
Estimating
uncertainties
Archiving
information &
reporting
Technical
reviews
Activity data
Q U A L I T Y P L A N N I N G / Q A / Q C

4. Q U A L I T Y P L A N N I N G
Proper planning
ensures that the
remaining Quality
processes make
sense and
achieve the
desired results.
The starting point
for the Planning
process is the
standards
followed by the
Organization. This
is expressed in
the Quality Policy
and
Documentation
defining the
Organization-wide
standards.
Sometimes
additional industry
standards
relevant to the
Product/Project
may be referred
to as needed.
Using these as
inputs the
Standards for the
specific project
are decided. The
Scope of the
effort is also
clearly defined.
What are the INPUTS required in
quality planning?
a. Company‘s Quality Policy
b. Organization Standards
c. Relevant Industry Standards
d. Regulations
e. Scope of Work
f. Project Requirements
What are the OUTPUT achieved
from quality planning?
a. Standards defined for the
Project / Product
b. Quality Plan
Quality tools are used in order to
achieve the output
(benchmarking, DOE, Cost of
Quality, etc).

5. F R A M E W O R K
QUALITY
PLANNING
QUALITY ASSURANCE QUALITY CONTROL
Find the cause of
defect or failures.
Corrective
action/Preventive
action
Execute the
corrective action
Find a defect or
failure.
Process
Update
Feedback

6. C O N S E Q U E N C E S O F P O O R Q U A L I T Y
1. Loss of business – Customer stops buying company’s product services.
2. Liability – Damages or injuries resulting from poor quality resulting from
design.
3. Low productivity – More rework or scrap. An increase in input, not increase
the output.
4. High costs – E.g. failure costs incurred by defective parts or products or
faulty services.

7. T O L E R A N C E S
DEFINITION
A tolerance is an acceptable amount of dimensional
variation that will still allow an object to function correctly.
Tolerances are used in
production drawings to
control the manufacturing
process and control the
variation between copies of the
same part.
LARGE TOLERANCES
May affect the functionality of
part
SMALL TOLERANCE
• May affect the cost of the part.
• Cost generally increases with
smaller tolerances.
• Require precise manufacturing.
• Require quality control with
inspection and rejection of parts.
DO NOT SPECIFY A
TOLERANCE THAT
IS SMALLER THAN
NECESSARY!

8. T Y P E S O F T O L E R A N C E S
Three basic tolerances that occur most often on working drawings.
Limit dimensions
• Provide an upper limit
& lower limit for the
dimension.
• Any size between or
equal to the upper
and/or lower limit is
allowed
Bilateral tolerance
• Provides an equal
allowable variation,
larger & smaller
• Uses a plus/minus (±)
symbol to specify the
allowable variation.
Unilateral tolerance
• Provides an allowable
variation in only one
direction (either larger
or smaller)
• Uses separate plus (+)
and minus (-) signs

9. E X A M P L E
Identify the type of tolerance
displayed in red color.

10. G E N E R A L T O L E R A N C E S
• General tolerances are tolerances that are assumed if no specific tolerance is
given for a dimension.
• Typically, tolerances are specified based on the number of digits to the right of
the decimal point in a dimension.
• General tolerances are shown on drawing.

11. S P E C I F I E D D I M E N S I O N A N D L I M I T S
• Specified dimension is the target dimension from which the limits are
calculated.
• Limits are the maximum and minimum sizes shown by the toleranced
dimension.
1. Upper limit: The maximum allowable dimension
Upper Limit = Specified Dimension + Positive Variance
2. Lower limit: The minimum allowable dimension
Lower Limit = Specified Dimension + Negative Variance

12. C A L C U L AT I N G T O L E R A N C E
• Tolerance is the total variance in a dimension & is equal to the difference
between the upper and lower limits.
Tolerance = Upper Limit – Lower Limit

13. O U T O F T O L E R A N C E S
• A manufactured part is said to be out of tolerance if the part is not within
specified limits.
• Manufacturing facilities often follow quality control measures to help ensure
that parts are within tolerance.

14. P R O C E S S C A PA B I L I T I E S
• Process capabilities are the
process abilities to generate
products or services that meet or
exceed customer’s requirements.
• The process capability analysis is
the bridge between specified limit
and control limit.
• It compares the variability of an in-
control and stable production
process with its engineered
specifications.
• Thus, capability indices are
generated to measure the level of
the process performance as it
relates to the customer’s
requirements.
Specified limits:
the voice of
customer
Control limits:
Related to the
voice of the
process
Control Limits < Specified Limits

15. P R O C E S S C A PA B I L I T I E S
• A process is said to be capable if the
process mean is centered to the
specified target and the range of the
specified limits is wider than the one
of the actual production process
variations (control limits).

16. S H O R T - T E R M P O T E N T I A L C A P A B I L I T I E S , C p
( P R O C E S S C A P A B I L I T Y )
• Given Cp:
 If Cp = 1 , the specified range equals the range of the natural variations of the
process, in which case the process is said to be barely capable.
 If Cp > 1, the specified range greater than the range of control limits, in which
case the process is potentially capable
 If Cp < 1, the specified range is smaller than the range of the control limits. The
process is said to be incapable.

17. S TA N D A R D O P E R AT I N G P R O C E D U R E S
( S O P )
• Standard Operating Procedures (SOP) are a set of written instructions to help individuals working in a particular
setting to carry out specific procedures correctly.
• The implementation of SOPs is important to attain an end result with the expected quality according to good
practice guidelines.
• Various types of SOP format:
1. Step-by-step format
• In some cases, it may be sufficient to create a simple numbered or bulleted list of steps to take when
completing a process.
• This format should be used only when the process in question is straightforward and, in the vast majority of
circumstances, can be completed without fail.
2. Hierarchical format
• The hierarchical format is used when more instruction may be needed in order to sufficiently complete a
given task.
3. Flowchart format
• Flowcharts are best used to illustrate SOPs when multiple outcomes are possible at certain points throughout
the process.
4. Graphic or infographic format

18. Step-by-Step Format
Hierarchy Format

19. Graphic Format

20. IN-CLASS ACTIVITY
Divide into two groups and
write the SOPs for MIU
laboratory safety rules and
regulations using the both of
following formats:
• Flowchart format
• Graphic or Infographic
format