2. Non conformance -Definition
• An activity, attribute, or document, is said to be
non-conforming if it fails to comply with
established requirements, and may lead to a
condition having an adverse effect on the
environment, safety, security, health, operations,
quality or reliability.
4. • Major nonconformance - A lack of an element,
procedure, or a non-fulfilled requirement, that puts
the process/system at danger, and could lead to
significant impact on ESS&H, operations, quality or
reliability.
• Minor nonconformance - An observed lapse in a
program, process, procedure, or requirement,
usually single incidents that do not have a significant
impact on ESS&H, operations, quality or reliability.
5. Distinction between Non-conforming and Defective
Non-conforming Defective
A unit or service is
non-conforming
when atleast one
quality
characteristic
causes a specified
requirement not to
be met.
A unit or service is
defective when
atleast one quality
characteristic
causes a failure to
satisfy an intended
purpose.
6. Absence of a
Well defined
System
Hazards
(sooner/later)
Threaten
Outputs or
schedules
Decision on action is required urgently
Quality Manager
7. • For the quality manager
Commitment
Credibility
Trust
Visibility
Peace of Mind
Benefits of a systematic approach
8. • For the business as a whole
Understanding of requirements.
Identification of causes and
preventive measures.
Knowledge
Quality improvements
Increased profitability
9. Stages involved in this process are:
1. Discovery
2. Identification
3. Segregation
4. Analysis
5. Approval
6. Documentation
7. Disposal
8. Closeout
9. Tracking
Process for managing non-
conformance
10. • Non conformance may be discovered at many
stages.
• An investigation should be made to make a
clear decision as to what should be done with
the items under consideration or what action
should be taken to avoid recurrence
11. • NMR(Non Conforming Material Report)
It is a document or computer record raised to
record occurrence, define conditions, identify
how to dispose of the items and giving
reference to documents initiating further
actions required.
12. Discovery
Information entered in the NMR during the
discovery stage includes:
1. Material number, issue and description
2. Specified and actual result
3. Quantity of the nonconforming items
4. Batch/order number
5. Originator’s name and the date raised.
13. Identification
• Upon discovery of the non-conforming material, it is
necessary that all such material is identified as non-
conforming materials or “Do not use” material.
• Commonly red labels or letterings are used in the following
forms:
Tote box label inserts
Adhesive tapes
Sign plates
14. Segregation
• Materials are segregated from all other
materials until a decision has been made on
disposition.
• Such an area is called quarantine area.
15. Analysis
There are 5 stages
• 1st
stage: To determine whether the item is truly non-
conforming, defective, or both.
• 2nd
stage: To determine the extent of non-conformance.
->The maximum deviation from specification.
->The quantity or rate of items non-conforming.
• 3rd
stage: To determine what effect the non-conformance
will have on the function or saleability of the product.
16. • 4th
stage: To determine what can be done with the items.
Major options available are:
->return to supplier
->sort, then rework, repair or scrap.
• 5th
stage: To determine who is responsible for causing the
non conformance or defect.
17. Approval
• It involves completing the NMR to indicate disposition,
liability and actions required which affected parties sign to
signify their approval.
• This may involve a meeting of nominated representatives.
• Involves walking the NMR around to those concerned or it
may be a single individual who completes the documents to
record occurrence, disposition and liability.
18. Documentation
• As a result of analysis and approval of
disposition, liability and actions agreed,
documents are raised to initiate actions.
19. Close out
• The quality function ensures that materials
are only used as approved on the NMR and
that follow-up actions for correction or
prevention are implemented. For rework or
repair this may involve the re-inspection of
the items.
20. Tracking
• Records of NMRs raised are maintained by the
quality function to determine whether the
actions taken are effective in reducing the
number of non-conformances.
21. Controls
• Ensure that all occurrences are exposed when
they occur.
• Therefore, it is necessary to consider the
major sources of non-conformances and the
key areas of exposure.
22. • Some of the many sources of non-
conformance are:
Design
Manufacturing planning
Suppliers
Material supply
Transportation
Customers
Warehousing etc.
23. • Discovery of non-conformances will occur in
one of the four areas:
1. Incoming Inspection
2. In-process
3. Final test/inspection
4. Customer returns
24. Incoming Inspection
• Purchased materials are inspected.
• Non-conformance is looked for on a sample basis,
generally on selected key parameters or
characteristics.
• For this area to be effective, it is essential that all
parameters or characteristics are inspected on the
entire sample quantity.
25. • Another important aspect relating to vendor
non-conformance, is the need for the
vendor to identify clearly the cause and
action being taken to prevent recurrence.
• To trigger and track this activity, many
companies issue a Corrective Action
Request(CAR) form to the suppliers.
26. In-process
In-process problems should be addressed
on a high priority basis.
Non
Conformance
(in process
Stage)
Defect/failure
Hampers/
Prevents
Further
production
27. Final test and inspection
• Handled in a uniform manner.
• It is conducted as specified.
• Non-conforming items should receive full
review and approval.
• The quality function handles such matters
often with the support from specialist
technical or engineering functions.
28. Customer Returns
• Sometimes handled by service department and
sometimes by quality function.
• Here, both corrective/preventive actions and
customer settlements and responses should be
considered.
• Even if the issue is handled by the quality function,
full knowledge and approval of the sales function is
necessary.
29. Conclusion
In spite of measures taken in design, planning,
manufacturing and throughout the business, the
process “MANAGING OF NON CONFORMANCE”,
is all about facing up to the fact that
specifications or standards have not been
achieved. If handled badly, all the earlier
measures taken will count for little. But, if
handled well, the process will serve as a
foundation on which all other activities can
depend and flourish.