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 in-process complaints, suppliers’ complaints & 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 In-chargeNeed-based
2Handling complaints from CustomerQuality In-chargeNeed-based
3Handling in-process complaintQuality In-chargeNeed-based
4Handling abnormality of supplierQuality In-chargeNeed-based

Procedure :

Handling Abnormal Situations:

Abnormal situations 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.

The operator/concerned person identifies the abnormal situation, stops production & immediately informs to Production supervisor for further action.

List of abnormal situations in the manufacturing industry:

  • A machine producing defective parts continuously
  • Repeated breakage of production equipment (m/c, tool & fixture)
  • The operator produces defective parts continuously
  • The operator detects defects produced by the previous process
  • Poka Yoke does not detect defective parts ( Poka Yoke not working)
  • Inspector fails in Poison test
  • Poke yoke bypassed
  • Absenteeism more than the Attrition rate
  • Parts fallen down
  • Bin fallen down
  • The instrument is fallen down
  • Instrument showing error
  • Gauge fallen down
  • Power Failure (Projection/Spot)
  • Machine parameters found out of spec during routine checking
  • Different grade materials used
  • The production runs on Lower Tonnage
  • Production run on temporary Fixture/ tool/ die.
  • The operator of Under Skill deputed
  • Overtime (Working more than 12 hours)
  • A machine producing abnormal noise.
  • The machine takes the stroke without pushing the paddle

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 in a customer-required format. (A3 sheet or customer-approved format)
  • Standardize the related document like FMEA, Control Plan, Operation standard & WI etc against the countermeasure.
  • Check the feasibility of horizontal deployment of countermeasures in similar parts/processes.
  • Check the effectiveness of countermeasures for up to three months.
  • In case the problem repeats then again why-why analysis done for the same defect

Handling in-process Complaints:

Put a Red bin near each machine to store Non-conforming parts. QC Inspector shall identify part defect during a patrol inspection. Then Non-Conforming part is moved to Red Bin and Red Bin Analysis is done on daily basis in the 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 the action taken is 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 like FMEA, Control Plan, Operation Standard & WI etc against the countermeasure.  
  • Check the feasibility of horizontal deployment of countermeasures in similar parts/processes.
  • Check the effectiveness of countermeasures for up to three months.  

QPCR raising (DAR) Criteria :

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

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

Defect Analysis Report (DAR) format:

Supplier complaint handling:

  •  QPCR is to be raised to the supplier for receipt rejection and for line-reported defects ( for dimensional & fit function ) and recorded into the Supplier complaint register.
  • Check all available stock (FG, WIP and Raw Materials) 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 countermeasures in similar parts/processes.
  • Check the effectiveness of countermeasures for up to three months. 

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