Procedure for handling abnormality in Quality

Purpose:

To understand clearly what is abnormality & abnormal situations and to make operators understand abnormality & abnormal situations and to further standardize the rules & routes to handle such situations. To learn about handling abnormality in quality.

Scope:

Handling of in-process complaints, suppliers & customer complaints.  

Abnormal situation:

An abnormal situation is one where a process variable goes outside its operating range and if not brought under control by appropriate response/action, may tend to an emergency situation.  

Responsibility:

 

S.NoActivityResponsibilityFrequency
1List of Abnormal Situation and their reaction planProduction Head/ Shift InchargeNeed-based
2Handling complaint of CustomerQuality InchargeNeed-based
3Handling in-process complaintQuality InchargeNeed-based
4Handling abnormality of supplierQuality InchargeNeed-based

Procedure :

Handling Abnormal Situation:

Abnormal situation define and display process-wise in Shop floors (Press Shop, Weld Shop, Machine shop etc) as per WI

The production supervisor informs to concerned person & after that identifies the root cause & analysis is done about the issue/situation.  After that Production supervisor/ Quality Engineer shall record the abnormal situation in the 4’M Change tracking sheet.

Operator/concern person identify the abnormal situation, stop production & immediately inform to Production supervisor for further action.

Customer Complaint Handling:

 As soon as the complaint is raised (by email/telephone) by the customer, Record it in the customer complaint register.

Check all available stock (FG, WIP and Customer-end) for the raised complaint

Make the operators aware of the In-house/Customer complaint. Display a one-point lesson (Quality alert note), if possible within the time period.

 Analyze the root cause of the problem with the cross-functional team (CFT) and take required countermeasures and submit an action plan within one week on customer required format. (A3 sheet or customer approved format)

Standardize the related document against the countermeasure.

Check the feasibility of horizontal deployment of countermeasure in similar parts/processes.

Check the effectiveness of countermeasure for up to three months.

In case the problem repeats then again why-why analysis is done for the same defect.

Handling in-process Complaint:

Put Red bin near each machine to store Non-conforming parts. QC Inspector shall identify part defect during a patrol inspection, after it Non-Conforming part move to Red Bin and Red Bin Analysis done on daily basis in Red bin analysis record.

Suspected Parts handling:   

Put yellow bin at PDI & Shop floor area to store Suspected Parts which fall down during production/part movement/part inspection. QC & Production supervisor jointly check/inspect these suspected parts and action taken mentioned below:  

Handling abnormality in quality, Suspected parts handling

Check all available stock (FG & WIP) as per lot no. & batch no. for the raised complaint if required. Also inform the customer, in case of outflow to customer.   Make the operators aware of the complaint. Display a one-point lesson (Quality alert note), if possible with a time period.

Analyze the root cause of the complaint with a cross-functional team (CFT) and take required countermeasures.

Standardize the related document against the countermeasure.  

Check the feasibility of horizontal deployment of countermeasure in similar parts/processes.

Check the effectiveness of countermeasure for up to three months.  

QPCR raising (DAR) Criteria :

In-house QPCR will be raised by QA in the following conditions:

  • Top two defects as per Pareto chart on monthly basis before 10th of next month
  • Assignable cause (Rejection more than 10 pcs) in a day of any part.
  • For any critical defect

Supplier complaint handling:

 QPCR to be raised to supplier for receipt rejection and for line reported defect ( for dimensional & fit function ) and recorded into the Supplier complaint register.

Check all available stock (FG, WIP and Raw Material) for the raised complaint.

 Make the operators aware of the complaint. Display a one-point (Quality alert note) lesson, if possible within the time period.

Analyze the root cause of the complaint with a cross-functional team (CFT) and take required countermeasures. 

Standardize the related document against the countermeasure.

Check the feasibility of horizontal deployment of countermeasure in similar parts/processes.

Check the effectiveness of countermeasure for up to three months. 

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