Managing Non-Conformance

ByLieutenant Colonel R Srinivas

Roll No: 24, 4th SemesterMBA(FT)-2008-10

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.

Non conformance

Major Minor

• 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.

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 characteristiccauses a failure to satisfy an intended purpose.

Absence of a Well defined

System Hazards

(sooner/later)

Threaten Outputs or schedules

Decision on action is required urgently

Quality Manager

• For the quality manager Commitment Credibility Trust Visibility Peace of Mind

Benefits of a systematic approach

• For the business as a whole Understanding of requirements. Identification of causes and

preventive measures. Knowledge Quality improvements Increased profitability

Stages involved in this process are:

1. Discovery2. Identification3. Segregation4. Analysis5. Approval6. Documentation7. Disposal8. Closeout9. Tracking

Process for managing non-conformance

• 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

• 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.

Discovery

Information entered in the NMR during the discovery stage includes:

1. Material number, issue and description2. Specified and actual result3. Quantity of the nonconforming items4. Batch/order number5. Originator’s name and the date raised.

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

Segregation

• Materials are segregated from all other materials until a decision has been made on disposition.

• Such an area is called quarantine area.

AnalysisThere 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.

• 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.

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.

Documentation

• As a result of analysis and approval of disposition, liability and actions agreed, documents are raised to initiate actions.

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.

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.

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.

• Some of the many sources of non-conformance are:

Design Manufacturing planning Suppliers Material supply Transportation Customers Warehousing etc.

• Discovery of non-conformances will occur in one of the four areas:

1. Incoming Inspection2. In-process3. Final test/inspection4. Customer returns

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.

• 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.

In-process

In-process problems should be addressed on a high priority basis.

NonConformance(in process

Stage)

Defect/failure

Hampers/PreventsFurther

production

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.

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.

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.

THANK YOU AND JAI HIND!