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.
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)
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
The instruments found out of calibration.
Customer Complaint Handling:
As soon as the customer raises the complaint (by email/telephone), Record it in the customer complaint register. Inform the concerned persons including top management.
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 effectiveness of countermeasures for up to three months.
Check the feasibility of horizontal deployment of countermeasures in similar parts/processes after verification of countermeasure effectiveness.
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 a 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:
OK PARTS
NG PARTS
WIP PARTS
SEND FOR PDI
SEND FOR RED BIN
HANDOVER TO PRODUCTION
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 effectiveness of countermeasures for up to three months.
Check the feasibility of horizontal deployment of countermeasures in similar parts/processes after effectiveness OK.
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 a monthly basis before the 10th of next month
Assignable cause (Rejection of more than 10 pcs) in a day of any part.
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 effectiveness of countermeasures for up to three months.
Check the feasibility of horizontal deployment of countermeasures in similar parts/processes.
