Procedure for 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.No	Activity	Responsibility	Frequency
1	List of Abnormal Situation and their reaction plan	Production Head/ Shift In-charge	Need-based
2	Handling complaints from Customer	Quality In-charge	Need-based
3	Handling in-process complaint	Quality In-charge	Need-based
4	Handling abnormality of supplier	Quality In-charge	Need-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:  

• 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 10^th 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.