TOTAL QUALITY
MANAGEMENT
GROUP 3
Migrino, Angelica E.
Palacio,Maria Nila Z.
Tabora,John Nicole T.
Yudelmo, Japeth S.
CONFORMANCE AND
NON-CONFORMANCE
TO QUALITY STANDARDS
Cost of Conformance:
This is the costs incurred by carrying out activities to ensure
the project and deliverables conform to the quality
requirements and avoid failure (i.e. building quality into the
project processes).
Prevention Costs money spent on activities/equipment to prevent defects
from arising in the first place.
Appraisal Costs money spent on those activities to inspect and dig out
defects to prevent these defects from getting into the hands of the customers,
Cost of Non-Conformance
This is the money that needs to be spent for not
conforming to the quality requirements.
Internal Failure Costs The costs incurred when defects in
the deliverables are detected internally (i.e. not yet
presented to the customers)
External Failure Costs The costs incurred when defects are found the
deliverables have been delivered to customers and in actual use (this is the
wrost kind of quality costs)
QUALITY OF DESIGN
QUALITY OF DESIGN
• is the quality which the producer or supplier is intending
to offer to the customer.
• When the producer is making the quality of design of the
product, he should take into consideration the customer's
requirements in order to satisfy them with fitness for
use of the product.
QUALITY OF CONFORMANCE
QUALITY OF CONFORMANCE
• The ability of a product, service, or process to meet its
design specifications.
• Design specifications are an interpretation of what the
customer needs.
• Quality of conformance is measured within an acceptable
tolerance range.
Example: if passengers expect a flight
to leave within 10 minutes of its
scheduled departure date, then any
departure time within that time frame
has a high quality of conformance,
while any longer interval does not.
CONTROL OF NON-CONFORMING
PRODUCTS
WHAT IS A NONCONFORMING
PRODUCT?
First, it may be useful to define exactly what a nonconforming
product is. For such a product to exist, one or more of the
following conditions must be present:
Formal verification activities
Removing a product from the material flow or product realization process
Operating conditions intended to produce conforming products
Risk to the organization
Identifying Nonconforming Products
• Tags, signs or stickers affixed to the product
• Labelled bins, boxes and bags
• Remarks or descriptions written directly on the product
• Tape or ribbon wrapped around the product
• Paint spots or other coded markings on the product
• Electronic identification, often by means of a barcode affixed to the
product
• Storing the product in specially marked areas
CONTROLLING NONCONFORMING
PRODUCTS
• Establishing special handling requirements
• Segregating from conforming products
• Securing in locked or protected areas
• Establishing documented procedures
• Defining chain of command for the documented procedures
• Training employees on procedures
• Defining timeframes for taking action
• Defining dispositions
• Recording nonconformities
• Connecting process to the corrective/preventive action system
Documenting Procedure
• Who can identify nonconforming products?
• Who can move or handle nonconforming
products?
• Who can authorize disposition of nonconforming
products?
• Who can carry out the disposition?
Disposition of Nonconforming Products
• Taking action to eliminate the detected nonconformity
* By repairing
* by reworking
* By reprocessing
By authorizing its use, release or acceptance under concession by a
relevant authority and, where applicable, by the customer.
By taking action to preclude its original intended use or
application.
* Scrapping.
* Recycling.
* Reprocessing.
* Upgrading
Records
• a description of the nonconformity
action taken, otherwise known as "disposition"
• re-verification (i.e., when the nonconformity has been corrected)
details of concessions, if any
Re-verifying Nonconforming
Products
• Evidence of conformity with acceptance criteria (i.e., actual measurements or
observations)
• Identification of the person authorizing the release (i.e., the person performing
the verification or responsible for seeing that the task is carried out)
Nonconformities detected later
For most goods, this system works fairly well and follows this
general sequence:
1.) The customer contacts the organization to report the nonconformity.
2.) If it's determined to be appropriate, the customer is issued A tracking
number of some sort. This number is often referred to as RMA (returned
materials authorization) or RGA (returned goods authorization).
3.) The customer is asked to mail or ship the product back to the organization,
referencing the assigned tracking number.
4.) When the product returns to the organization, it's
handled much like any other nonconformity. The primary
difference is that there may be the additional issue of
crediting the customer for all or part of the product's
cost.
5.) Corrective action is initiated to determine and
eliminate the root cause of the nonconformity, as with in
any other nonconforming product situation. The key
benefit of A returned goods process is that the
organization can see the nonconformity for itself, rather
than just hearing about it.
Integrating to corrective action
The organization must evaluate, among other considerations, the
organizational risk and potential impact on customer satisfaction, and
then take action that logically fits the description of "appropriate."
CORRECTIVE AND
PREVENTIVE ACTIONS
Corrective and Preventive Actions
are key elements to a Quality Management System (QMS) that is focused
on continuous improvement and customer satisfaction.
Corrective Action
is a reactive process to address concerns or issues after they have occurred. It
assumes that a non-conformance or problem has been identified and has been
reported. The problem might be identified in processes, materials, suppliers, the
product, the service, the workplace, or the management system itself.
In ISO 9001: it means that you eliminate the problem and make sure
it will not happen again, so the corrective actions you take will also
include the longer term actions you take to make sure the problem
will not occur again.
You might find opportunities for corrective actions through:
conducting workplace inspections
testing, inspecting, and monitoring of plant and equipment
consulting with staff
customer feedback
audits
hazard reporting
dealing with any non-conforming product
investigating complaints
reviewing system failures
reviewing regulatory requirements
Purpose:
review and document the problem
contain or temporarily fix the problem. e.g. remove the defective product from
production and quarantine it in a designated area for later investigation
Investigate the cause of the problem – how did it happen, why did it happen, could
it happen again?
Propose an appropriate solution that will prevent the problem happening again.
This will often mean a change to the process, and/or the system.
You need to report on what actions were actually taken.
After an appropriate period of time, you will need to assess whether the actions
taken were successful in preventing recurrence. Document the evidence to support
your decision.
Once you are satisfied the problem is not recurring, you can close the issue.
Records of your corrective actions provide evidence that the problem was recognized,
corrected, and proper controls installed to make sure that it does not happen again.
Preventive Action
Is a proactive process and is initiated to stop a potential
problem from occurring or from becoming too severe. Preventive
action focuses on identifying negative trends & addressing them
before they become significant.
If something has already gone wrong, it is a non-conformance
that is addressed with corrective actions.
You can identify opportunities for preventive action (or risks and
opportunities) in many ways:
Through the management review process
Process / performance monitoring
Analysis of warranty data and customer feedback for trends
Process analysis
Look for trends in the root causes of corrective actions
Risk assessment, FMEA – Failure Mode Effects Analysis
Employee suggestions for improvement
Contingency planning, Disaster recovery planning
Production planning
Monitoring changes in legislation, regulations
Reviewing changes in the marketplace
Assessing new technology
Internal / External Quality Audit Findings
Employee Observation
Once you’ve identified a potential source of problems and the possible effects, you need to
assess how likely it is to happen, and whether the costs associated with reducing the risk are
worth it. This is effectively risk-management.
If you are documenting a Preventive Action or ‘Managing Risk’ procedure, you should
include information on:
How you identify a potential problem
Where and how it should be recorded
how the potential causes should be investigated, and by who
deciding on what action will be taken
how to record the actions taken
assessing the solution for effectiveness and documenting the evidence to support your
decision.
when and who can finally close the issue.
The records you keep on actions taken provide evidence that
an effective quality system has been implemented and that it is
able to anticipate, identify and eliminate potential problems.
If you decide to do nothing in response to an identified risk,
be sure to document the reasons behind the decision.
