10.2 Nonconformity and Corrective Action Procedure

This article explains the complete procedure of nonconformity and corrective action.

Many quality engineers are thinking that the nonconformity are NC in the audit.

This is also correct, but according to ISO or IATF clause 10.2 the nonconformity is related to complaints.

And when complaint occurs then the corrective action is must to have a improvement in organization.

Taking corrective and preventive action will resolved issues.

So this guide will tells you how exactly the process or procedure created for such quality management system requirement.

Let’s dive in.

What is Nonconformity?

Nonconformity is defined as any deviation from it specification or standards or customer requirements.

ISO & IATF requirement for Nonconformity and Corrective Action

In Clause 10.2.1 it is stated that when there is any nonconformity occurs, weather its from internal or customer or from complaints, then the organization must act on it.

Organization should take action to control or correct it and deal with all consequences.

Find out the root cause of nonconformity and eliminate the cause that it will not recur or occur in the future.

This process should include the root cause analysis, take appropriate action, check the effectiveness of action implementation. Once it all goes well then update this risk and opportunities in respective documents. Update respective changes into quality management system if needed.

In Clause 10.2.2 it stated that the organization must retain this documented information as evidence includes nature of nonconformity, their action and respective results.

Nonconformity and Corrective Action Procedure Example

1.0 PURPOSE

Establish a procedure to prevent unintended use of nonconformity and/or non-conforming products.

2.0 SCOPE

Applicable for all nonconformity and Control of all Non-conforming products at all stages.

3.0 RESPONSIBILITY

QMS Coordinator & All Section Representative

4.0 DEFINITION / ABBREVIATION

NIL

5.0 PROCEDURE of Nonconformity and Corrective Action

All Section Representative identifies the Non-conforming parts during various stages. Includes like incoming, in process production, final inspection, inspection reports and returned by customers if any complaint or claim.

All customers claim returned product are re inspect in company as per final inspection criteria and maintain the record accordingly. After segregation ok and accepted material are moved to finished goods and rejected material is transfer to rejection area with red tag identification of complete detail as per format of tagging system.

Immediately analyzed  record all non-confirming Product & Process.

Use identification method. All non-confirming products are identified using Red Color Tag/marking. All parts are stored in dedicated red bin as quarantine place.

Quality manager and including quality control representative and other relevant authorities find out the nature of non-conformance and take appropriate actions on it. EIther it needs to dispose of or rework depends on type of non-conforming products.

After re-worked products should meet the specified requirements.

If the products are at acceptable level with or without rework or repair then should be accepted with concession (under deviation). Internal or customer deviation.

Use an alternative solution or scrapped ( all scraped materials are kept in a red bin storage system with lock and key and discard it at defined frequency (Monthly).

Re-investigate all reworked products. Inspection done as per control plan or quality plan (As per rework and repair procedure) and after approval and meet to the specification, send to the next operation phase.

If products are accepted under deviation of relevant authority, in this case all deviation reports and records are maintained in Concession/ Deviation Note.

Records maintained as per reworked and repaired with approval and re-inspection or scrapped.

CORRECTIVE ACTION

Determining and implementing corrective action is needed for all nonconformities including customer claim or complaint, customer feedback or internal rejections. Find out causes of nonconformities, evaluate the need for action to make sure it does not reoccur.

Data of customer claim, customer returned, supplier rejection, in-house rejection is maintained and recorded.

To resolve complaints, immediate action is taken for satisfaction of internal or external customer. Also to prevent their reoccurrence.

Investigate the process and system for root cause of all non-conforming products. Fill the counter measure report (8D Report) of all investigated results and findings.

Once root cause identified, take corrective action to eliminate the root cause and avoid reoccurrence of failure or nonconformity. Respective department representative must agreed and consult corrective actions.

Recognize or congratulate the accomplishments & team process for resolving issues.

Problem Solving process

Problem definition: Describe the problem in details such as 5W-2H method. (What, When, Where, Why, Who, How & How big). Specify external or internal customer problem in detailed.

Take appropriate containment actions (Common containment actions include:100% sorting of parts at in-house and customer side, Rework at in-house and customer end )

Find out root cause: Identify potential causes which could lead to why the problem occurred. 

Test each potential cause for the problem symptoms and data to identify the exact root cause using five times, why-why analysis in order to get to the root cause of the problem?.

Root cause analysis done by the team discussion and efforts. It can be more than one cause.

Once root cause identified, find out the possible corrective action. 

Select appropriate corrective action to solve the problem permanently.

 Implement best corrective action. After implementation  of corrective action monitor and check the effectiveness of action to ensure the corrections are permanent.

Once the action is correct and effectiveness also found ok then closed the problem. Make changes in all related documents and close the Nonconformance.

If the same problem or nonconformity is potentially applicable to similar or other products then horizontally deployed the same.

6.0 REFERENCE DOCUMENTS

• IATF 16949:2016 Standard
• ISO 9001:2015
• Change Management Procedure
• Training Procedure

7.0 RECORDS

8.0 CHANGE HISTORY

Download Nonconformity and Corrective action procedure template