Sample Procedure DControl of Nonconforming

Product & Corrective Action

AUDITING SKILLS COURSE

RTA Manufacturing Services Advisory Unit

Sample Procedures

Please do not mark this

handout

Please hand back at the end of the course

document.doc Page 1

RTA Manufacturing Services Advisory Unit

Control of Nonconforming Product & Corrective Action

Scenario

The RTA (Roads and Traffic Authority) Manufacturing Services Advisory Unit is involved in manufacture and subcontracting of steelwork for roadways projects.

Products include steel barriers, fences and structural framework.

Your Task

To audit the procedures for the Control of Nonconforming Product and Corrective Action at their main workshop facility.

The auditee will be Peter White, the Workshop Supervisor.

ManufacturingServices Advisory Unit

Roads and Traffic Authority Procedure No: TLB-SOP-413001

Control and CorrectiveAction of Non-conforming

Goods and Services

Prepared by: ................................................. Date: .......................Quality Coordinator MSAU

Approved by: ................................................. Date: .......................Technical Supervisor MSAU

Authorised by: ................................................. Date: .......................Manager MSAU

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Procedure No: TLB-SOP-413001 Issue No: 2.2 (Sept-95) Page 1 of 10

Purpose

To establish and maintain a system for ensuring that Non Conforming materials, items, products or services are promptly detected, documented and allocated a disposition.

To ensure that all non conforming materials, items, products or services are processed in a consistent manner, which prevents their use and / or distribution to customers and the resultant corrective or preventative action is taken.

Scope

This procedure covers identification, segregation, disposition and corrective action for non conforming materials, items products or services.

The people who should follow this procedure are:

All employees who detect a non-conformance.

Requirements

You should understand that non-conforming products or services are any materials or work, items of hardware or software, parts or assemblies, equipment, electronic or otherwise and documents that vary in some way from the specified requirement.

You should refer to the following documents:

TLB-SOP-413001 F01 Non-conformance report (NCR)

TLB-SOP-413001 F02 Non Conformance Status log

TLB-SOP-414002 Customer complaints

Non Conformance Status Logs shall be controlled by the MSAU Quality Coordinator.

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Procedure No: TLB-SOP-413001 Issue No: 2.2 (Sept-95) Page 2 of 10

Procedure

1. Identify Non-conforming Products or Services

Responsibility Action

All people Any person who detects a non conformance shall immediately segregate (if possible), the affected product from any product that is acceptable.

If it cannot be physically segregated then it should be labelled, taped or otherwise identified as Non Conforming.

A Non conformance can also be generated from a customer complaint.

The next step is to:

Fill in box 1 of the NCR

or

contact their supervisor to fill in box 1.

In the bottom half of section 1 describe the immediate corrective action taken.

When section 1 has been completed, send the NCR to the line manager in the area from where the non conforming product or service originated.

Note: If the NCR is the result of an internal audit, the NCR number is allocated differently according to procedure TLB-SOP-417001 Quality audits and the NCR is recorded in the Audit report status log TLB-SOP-417001-F02 in lieu of the NCR status log.

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Procedure No: TLB-SOP-413001 Issue No: 2.2 (Sept-95) Page 3 of 10

2. Register the NCR

Responsibility Action

Supervisor On receipt of the NCR, the relevant Supervisor is to register the details in the Non-conformance Status Log, Form TLB-SOP-413001-F02 (held by the quality coordinator) and take the next consecutive number for the NCR (Enter in top right corner of NCR).

Ensure the products are labelled as non conforming and the NCR number is cross referenced on the label.

Ensure that wherever possible, the products are separated to stop them from being used.

If there is sufficient information in section 1 of the NCR to decide on corrective or preventative action, sign off section 2 of the NCR and go to section 3.

If there is not sufficient information to enable a decision to be made on the corrective action, appoint an investigator by completing section 2 of the NCR.

If an investigator is appointed, give the investigator the NCR form.

Where a non conforming product or service originates from an external supplier, you must notify that supplier and note that you have done so on the NCR (Section 3).

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Procedure No: TLB-SOP-413001 Issue No: 2.2 (Sept-95) Page 4 of 10

3. Investigate the Non ConformanceResponsibility Action

Investigator

When you receive a NCR you must

Analyse any processes, operations, records or customer complaints that relate to the Non Conformance.

Assess the seriousness of the defect – ie determine the impact of the non conformance on other similar items and provisions for service.

There are several types of action available, ie Return to supplier Scrap Rework by RTA Rework by vendor Use as is (no action)

Recommend what controls are to be put in place to ensure that corrective actions are taken. The results of the investigations are to be documented in section 3 of the NCR (attach additional sheets if required).

Note: use as is dispositions can only be used when the safety/performance of the product cannot be affected and/or the customer has agreed that the product is fit to use.

Where required by contract, the proposed use or repair of product which does not conform to specified requirements shall be reported to the customer.

The NCR is then returned to the supervisor who appointed you as investigator.

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Procedure No: TLB-SOP-413001 Issue No: 2.2 (Sept-95) Page 5 of 10

4. Determine corrective/Preventative action

Responsibility Action

Supervisor When you receive the NCR form back from the investigator, decide whether you agree with the proposed corrective/Preventative action.

If you do not agree or there is insufficient information on which to act, contact the investigator for further or more detailed investigation.

When you agree on the corrective/preventative action, determine who is to take that action and complete section 4 of the NCR to define:

who must perform the action (the action officer)

the cost centre for the action

the required completion date and delivery point

any progress reporting requirements

Send the action officer(s) a copy of the form.

Note: If the corrective action involves recalling products which are already being used, you must use procedure TLB-SOP-402005 Product Recall.

5. How to perform corrective/preventative action

Responsibility Action

Action Officer

If you are appointed as an action officer, that is, someone to take corrective action, you must:

complete the action by due dates

report any difficulties to your supervisor

implement and record any changes carried out in procedures, resulting from corrective action

notify the supervisor when you have completed the corrective action, using Section 5 of the NCR form.

Note: In the event that the non-conforming product requires repair, then appropriate re-inspection and re-test of the material shall be carried out in accordance with the documented procedures.

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Procedure No: TLB-SOP-413001 Issue No: 2.2 (Sept-95) Page 6 of 10

6. How to verify and record corrective/preventative action

Responsibility Action

Supervisor

Quality Coordinator

When you receive the NCR form back from the action officer, you must:

verify that corrective/preventative action(s) has been completed and is effective.

complete section 6 of the NCR form and deliver it to your quality coordinator.

fill in the Non conformance status log, to finalise action, recording relevant dates, name of investigator etc.

ensure controls are in place to ensure that any corrective or preventative action taken is effective.

feedback information to originator

should further action be required another NCR is to be raised.

Note: If the NCR is a result of an internal audit, the quality Coordinator would fill out the audit report status log in lieu of the Non conformance status log.

At monthly intervals the Quality coordinator will obtain information on the status of any NCR’s, and analyse to detect any trends or recurring problems. These are to be presented at the management review meetings.

7. Preventative action

Responsibility Action

All MSAU staff Should a potential nonconformity become evident as the result of quality audits, quality records, process or operation, a non-conformance report is to be initiated as per steps 1-6 of this procedure.

This information is to be tabled at the monthly management review.

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Procedure No: TLB-SOP-413001 Issue No: 2.2 (Sept-95) Page 7 of 10

Identify and Investigate a Non Conformance

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Procedure No: TLB-SOP-413001 Issue No: 2.2 (Sept-95) Page 8 of 10

Appoint Investigator

Investigate problem

Recommend solution

No

Step 2

Step 1

Step 3

Step 4

Supervisor

Investigator

Section Supervisor

Originator/Supervisor

Follow procedure TLB-SOP-417004 Auditing

If product recall

required then use

procedure TLB-SOP-

402005

NCR form

Section 2

NCR form

Section 3

NCR form

Section 4

NCR form

Section 1

Audit Report Status Log

Non Conformance Status Log

or

Y

Yes

Detect Non Conformance

Is the NCR a result of

internal audit

Send NCR form to Section Supervisor

Fill in section 1 of the NCR form

(Tlb-sop-413001-f01)

Register the NCR on the Non Conformance Status Log (TLB-SOP-413001-F02) or Audit Report Status Log (TLB-SOP-417001-F02)

Is further investigation needed?

Agree with investigator’s findings?

Appoint action officer

NO

Yes

N

A

Taking corrective and preventative action

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Procedure No: TLB-SOP-413001 Issue No: 2.2 (Sept-95) Page 9 of 10

Compare NCR to others for trends, common

problems, etc

Preventative action

Go to

step 1

or

A

Action officer

Supervisor

Quality Coordinator

MSAU Staff

Step 5

Step 6

Step 7

Undertake corrective/Preventative action

Verify corrective/preventative action

Sign NCR form and record details on Non

Conformance Status Log

NCR form

Section 5

NCR form

Section 6

Audit Report Status Log

Non Conformance Status Log

Document file name: LB413001.DOC©Roads and Traffic Authority 1995

For further information regarding this procedure please contact:MSAU Quality Co-ordinator

Level 2 Southern Office Block52 Rothschild Avenue, Rosebery NSW 2018

Phone: (02) 9662 5033

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Procedure No: TLB-SOP-413001 Issue No: 2.2 (Sept-95) Page 10 of 10

NON-CONFORMANCE STATUS LOGManufacturing Services Advisory Unit

Location: Manager:NCR No.

File No.

Date Raise

d

Investigator Action Officer Description Completion Verified

New NCR No (if applicable)

ISSUE No 1.1 (April 95) TLB-SOP-413001-F02

Non-conformance Report Manufacturing ServicesAdvisory Unit

NCRNo:

□Nonconformance – Quality System □ Process Improvement

Suggestion

□Non conformance – Goods or Services □Document Change

Request/Suggestion

□ Potential Non-conformance (preventive action

required)

□Customer Complaint

1. ORIGINATORThe person who discovers the non-conformance, receives the customer complaint, or makes a suggestion writes the details in this section

Your name:

Describe the problem, suggestion or complaint.

(attach a separate sheet if you need more room)

Your signature: Date: / /

2. SUPERVISORRegister the NCR, Customer Complaint or Suggestion with the Quality Coordinator & appoint an Investigator. The “Supervisor” is the supervisor or manager in charge of the activity, service or product which is non-conforming, or about which a customer complaint or suggestion has been made.

Register the NCR (Record number on top right of form

Date: / /

Is further investigation required

No- use box 3 to describe action

Yes →

(Name investigator – either yourself or you can appoint someone else

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TLB-SOP-413001-F01 Issue No 1.3 (Nov-95) Page 1 of 2

requiredResponse required by

Date: / / Your signature: Date: / /

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TLB-SOP-413001-F01 Issue No 1.3 (Nov-95) Page 1 of 2

3. INVESTIGATORInvestigate the non-conformance, customer complaint or suggestion. This is done by a person nominated by the supervisor.

Describe the proposed disposition.

Describe the proposed corrective action

Describe the proposed preventive action

(Attach a separate sheet if you need more room)

Your signature: Date: / /

4. SUPERVISOR If there has been an investigation and you don’t agree with the investigator’s

findings, send the NCR back to the investigator. If you agree with the investigator’s findings or if an investigation was not needed,

appoint an Action Officer fix the problem or complaint, or Implement the suggestion.

Appoint action officer

Action required by Date: / /

Determine cost centre (optional)

Progress report required by (optional)

Date: / /

Your signature

Date: / /

5. ACTION OFFICERThe action Officer signs here to confirm that the action is complete.

Your signature: Date: / /

6. SUPERVISORThe supervisor signs here to verify that all investigations and subsequent action is complete.

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TLB-SOP-413001-F01 Issue No 1.3 (Nov-95) Page 2 of 2

Your signature: Date: / /

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TLB-SOP-413001-F01 Issue No 1.3 (Nov-95) Page 2 of 2