Procedure for handling abnormality in Quality

Scope:

Handling in-process complaints, supplier 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.  

An abnormal situation in manufacturing refers to an unexpected event or deviation from normal operating conditions that can lead to reduced productivity, increased costs, or even safety hazards. Examples of abnormal situations in manufacturing include equipment failures, power failures, natural disasters, human errors, and changes in demand or supply. These situations can cause disruptions in the production process and require a quick and effective response in order to minimize their impact on manufacturing operations.

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 work instructions.

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 fell 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
• The production runs on temporary Fixtures/tools/ 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/ CAPA format 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 that fall down during production/part movement/part inspection. QC & Production supervisor jointly check/inspect these suspected parts and the action taken is mentioned below:  

• Make a summary of all the defects that occurred at the end of the month.
• Make a Pareto chart of defects and partwise and take action on top defects. Select all department top defects for analysis.
• 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 one 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, for line-reported defects and customer-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.