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To understand clearly what 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.
Handling in-process complaints, supplier complaints & customer complaints and abnormal situations.
An abnormal situation is where a process variable goes outside its operating range and may tend to an emergency if not controlled by an appropriate response/action.
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 to minimize their impact on manufacturing operations.
| 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 |
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 the 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 the Production supervisor for further action.
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 the Red Bin and Red Bin Analysis is done daily in the Red bin analysis record.
Put yellow bin at PDI & Shop floor area to store Suspected Parts that fall during production/part movement/part inspection. QC and production supervisor jointly check/inspect these suspected parts and the action taken is mentioned below:
| Types of Part | Action |
|---|---|
| OK Parts | Send for PDI |
| NG Parts | Send for Red Bin |
| WIP Parts | Handover to Production |
Do you define clearly what is an abnormal situation and make operators know the definition?
| Sub Question |
|---|
| What is the definition of abnormal situations? |
| Are the abnormal situations displayed on the shop floor? |
| Check awareness of abnormal situations among the shop floor personnel |
Do you clarify and standardize the handling rules/routes for customer claims, in-process failure and supplier failure?
| Sub Question |
|---|
| Check the availability of Procedures for handling customer complaints, in-process failures and supplier defects |
| Criteria for raising QPCR (internal QPCR to be raised in case of daily abnormal rejection and monthly top rejections) |
| Check for availability of Customer complaint register and QPCR control registers (for in-house and supplier defects) |
Do you have criteria to estimate the scope of the suspected lot for abnormal situations? When an abnormal situation occurs, do you trace the suspected lot based on the criteria?
| Sub Question |
|---|
| Check criteria to estimate suspected quantity produced during abnormal situations and system to trace suspected lots produced based upon the criteria |
| Check the record of parts produced during abnormal situations |
| Check for their Traceability |
Prevention of recurrence. -Customer claims -In-process failure -Suppliers failure
Do you prevent the recurrence of issues by analyzing the cause of occurring defects based on process investigation results such as 5-why analysis?
| Sub Question |
|---|
| Analysis sheet ( A3/CAPA) for analyzing customer complaints, in-house defects and supplier defects |
| Monthly in-house rejection analysis (defect-wise Pareto and analysis) |
| Quality of analysis (root cause analysis) |
| Non-conforming parts produced due to defects (Reported at the customer end, inhouse defects or supplier defects) checked or not |
Do you reflect corrective action to improve process control and review of standards?
| Sub Question |
|---|
| Check the Countermeasures detail for the root cause |
| Standardization (Control Plan, WI/OS Inspection standard, check sheets, list of abnormal situations etc.) |
| Check for updation of PFMEA |
After corrective actions are taken, do you conduct an on-site check and evaluate the effectiveness? And horizontal deployment.
| Sub Question |
|---|
| Evidence of onsite verification of countermeasures (to be checked for min three months) |
| Check for Horizontal deployment of countermeasures |
| Effectiveness of countermeasure (to be checked for min three months) |