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DISCREPANCIES & NCRs

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What’s a Discrepancy?

A variation from the Standard or the management system documentation – a statement of fact substantiated by objective evidence.

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Writing Discrepancies

• Discrepancy List

• list what is wrong, not what should be done

• use current tense

• note relevant clause of Standard

• don’t personalise

• include any observations.

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Examples

D1 5.6 Purchasing Manager did not attend last Management Review Meeting (QM 14 requires him)

D2 5.6.1 Last Management Review did not discuss internal audits (agenda at QM 14, para 5).

Obs1 5.6.2 The Company might consider including a summary of outstanding action from all previous meetings in the minutes.

• not written like an NCR

• include any which may also be an NCR.

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Common Errors

• written like a NCR – “the system does not”

• not referring to evidence

• not using their terminology

• “the Company should ………..”

• past tense

• opinion!

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Definition of a Nonconformance

•Minor - a discrepancy or a number of discrepancies which indicate a breakdown in part of the management system.

•Major - a very significant discrepancy or a number of discrepancies which indicate a very serious breakdown in the management system.

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Writing NCRs

Three parts of a Nonconformance Report:

• relevant clause of the Standard

• about the System

• evidence!

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Wording NCRs

Standard, Clause:

The System does not always ensure that …………………………………………..

…………………………………………..

in that …………………………………..

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Wording NCRs…cont.

Standard, Clause:

The System does not always ensure that …………………………………………..

…………………………………………..

(Discrepancies #3, 5 & 6 refer).

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Examples of NCRs

eg “ISO 9001:2008 clause 8.5.2. The System does not always ensure corrective action is reviewed in that CAR #45 has not been closed even though action has been completed for three months.”

or “ISO 9001:2008 clause 4.2.3. The System does not always ensure documents required by the management system are controlled (Discrepancies 2, 6, 13 & 18 refer).”

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Wording the Systemic Breakdown

Reword the actual phrase from the Standard

• don’t state what they should do

• don’t state what the Standard requires

Reword the actual phrase from the Standard!

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What If?

What could the client do if the NCR read:

• the gauge blocks are not calibrated

• or the internal audit has not been conducted in the last 12 months

• simply fix the immediate issue.

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NCR Action Plan

Must normally address a System change to be effective!

•what action is intended (both immediate and for the root cause)

•when they are intended to be completed.

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Common Errors

• only stating the evidence

• NCR against their documentation instead of the Standard

• wrong clause – therefore wrong Systemic issue

• NCR for something not required by the standard – eg MR meeting not conducted in last 12 months.

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Example of a Poor NCR

ISO 9001, Clause 7.1.

Material is not getting to the Assembly Area on time

doesn’t address the System nonconformance.

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Example of a Good NCR

ISO 9001, Clause 7.1. standard/clause

The system does not always ensure the

organisation establishes processes and provides

resources specific to the product, about the System

in that material is not always available to

Assembly for manufacturing umbrellas on time.

evidence.

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Thank You