PROCEDURE FOR VERIFICATION AFTER MAJOR SHUTDOWN

PROCEDURE FOR VERIFICATION AFTER MAJOR SHUTDOWN

If any planned or unplanned shutdown is more than 30 Days then verify the production facility.

 Ensure that the production process outputs are complying with the necessary product requirements as per the control plan or process plan as necessary and as applicable depend on shut down time and nature of shutdown 

by following ways,

1. Job Set up Approval Report

2. By checking plant facility and layout condition

3. By revalidating the processes.

4. By doing manufacturing process audit

5. By doing product audit

6. By submitting sample lot to customer for verification 

7. By taking functional feedback from customer for sample lot.

8. By doing Machine fitness test if any.  

Take necessary approvals from concern customers like resubmission of samples, PPAP report, SPC report or any audit from customer as per the customer specific requirements etc. after the shutdown is over.

PROCEDURE FOR JOB SET UP APPROVAL

PROCEDURE FOR JOB SET UP APPROVAL

Ensure that the setting layout are accessible and understood by the concerned operators.

  

Carry out component setting as per Operational Control Procedure.

 
Carry out Job set up verification on the following occasions:
a.  Initial run of the job (First piece approval)
b.  Daily at Start of Production
c.  Different job is to be taken up
d.  When the time period between 2 runs is more than 24 hours.
e.  Also verify the setup in case any major maintenance is carried out in the machinery.
f.  Whenever material change over takes place i.e. whenever material with from different supplier is processed.

Continue the operation in case the job setup inspection is conforming to the requirements.

In case the job setup inspection is not OK, then stop the machine, investigate the root cause of the non-conformity, take disposition action & take trial run and follow the approval process.

Keep job set up approved pieces separately and compare with the last piece of the shift and maintain the record of last piece inspection if feasible.

PROCEDURE FOR EMPLOYEE RECRUITMENT

PROCEDURE FOR EMPLOYEE RECRUITMENT

Requirement of man power for Assistants, Inspectors, Incharge and above level is received from concerned department heads through e mail.

Update the list of required employment.

The requirement is matched with the existing qualification matrix and the qualification requirements are identified.

In case of special qualifications required, it is provided by the concerned department and pre approved from Top Management.

Corrosponding CV’s are collected from placement agencies/ other sources.

The suitable candidates are lined up for interview by the Interview Team.

If the candidate is found suitable, he/she is given an Appointment Letter.

 If Appointment Letter is accepted , the date of joining is finalized.

 

Appointment letter is given to the new employee.

Do not appoint the personnel below 18 years.

A personal file is prepared for the new employee containing details of Qualification, Experience and other related documents. 

Following list while employee recruitment,

ID PROOF ( ADHAR CARD)

AGE PROOF

QUALIFICATION CERTIFICATE

IATF16949 {6.1.2.3} Contingency Plans

IATF16949 {6.1.2.3} Contingency Plans

The organization shall:

 

a) identify and evaluate internal and external risks to all manufacturing processes and infrastructure

equipment essential to maintain production output and to ensure that customer requirements are met;

b) define contingency plans according to risk and impact to the customer;

c) prepare contingency plans for continuity of supply in the event of any of the following: key equipment failures. (alsoseeSection8.5.6.1.1); interruption from externally provided products.

processes, and services; recurring natural disasters; fire; utility interruptions; labour shortages; or infrastructure disruptions;

 

d) include, as a supplement tothe contingency plans,a notification process to the customer and other interested parties for the extent and duration of any situation impacting customer operations;

e) periodically test the contingency plans for effectiveness(e.g simulations, as appropriate);

 f) conduct contingency plan reviews (at a minimum annually) using a multidisciplinary team including top management, and update as required;

g) document the contingency plans and retain documented information describing any revision(s). including the person(s) who authorized the change(s).

The contingency plans shall include provisions to validate that the manufactured product continues to meet customer specifications after the re-start of production following an emergency in which production was stopped and if the

regular shutdown processes were not followed.

Explanation: Please follow below Procedure for Making Contingency Procedure 

HOW TO IDENTIFY CONTINGENCY PLAN

Identify internal as well as external risks involved in manufacturing processes as well as minimum essential infrastructure required to get the required production to fulfill the customer requirements.

Identify the possible contingency can occur like
1.  Power Failure
2.  Labour Shortages
3.  Key Machinery Failure
4.  M&M Equipments failure
5.  Natural Disasters
6.  Interruption due to External provided sources
7.  Infrastructure disruption

Decide suitable contingency plan wherever possible for possible contingency.

If contingency plan is not available then decide suitable actions like,
1.  Deviation from customer on delivery
2.  Safety stock availability
3.  Reduce Lead time to rectify the contingency

Alternative work if any, communicate contingency plan within the organization by suitable ways i.e.

1.  By giving Internal Trainings
2.  By providing Copy of contingency plan
3.  By fixing the responsibilities to perform

If customer requirements, communicate contingency plan by giving one copy or as per the customer requirements.

How to test Contingency Plan & Review

Decide suitable action and frequency to test the contingency plan based on past experience of contingency occurred and criticality of contingency and existing control of contingency actions decided.

For any contingency actions is linked to external providers services or operation or activity, inform supplier about the testing plan and requirements.

If any contingency occurred and handled as per the contingency plan, records of same can be maintained as contingency testing record.

Keep record of contingency testing and update the contingency plan as necessary.

Review the contingency plan at least once in a year by forming a team from different sections like Production, Quality, Purchase, top management, HR etc. based on

1.  Contingency tested
2.  Contingency occurred and response
3.  Changes in customer requirements
4.  Changes in infrastructure
5.  Changes in manpower

Maintain the record of review and update the contingency plan as necessary.

PROCEDURE FOR INITIAL PRODUCTION CONTROL (IPC)

PROCEDURE FOR INITIAL PRODUCTION CONTROL (IPC)

Quality Head will announce start of IPC by updating the part in IPC logbook and call the CFT meeting for informing about IPC part and decide targets for the IPC periods in IPC Monitoring sheet.

Quality Head further provide training to concerned person regarding the IPC part

IPC starts from SOP at Customer End to -

- New Part: 3month/3lot/5000 parts whichever is later or as required by Customer

- ECN : 1month/2lot/1000 parts whichever is later or as required by customer

 - PCN : 1month/2lot/1000 parts whichever is later or as required by customer

During the IPC period, Stricter Control shall be followed from incoming to final like increase in sample size/frequency, 200% Visual Inspection in Final

Change in inspection method shall also be done from attribute to variable gauge if possible or required by Customer.

Pre-launch control plan shall be used during the IPC period with defined Stricter Inspection as mentioned above for monitoring of part

During the IPC period, the part shall be identified by IPC tag

Detail of each lot during the IPC period shall be monitored in IPC tracker sheet with detail for rejection.

IPC period shall be terminated by QC Head in IPC monitoring sheet.

In order to terminate the IPC period, the target defined shall be met, sustain and have improving trend

If target not met the IPC period shall be extended from point of failure to

-New Part: 3month/3lot/5000 parts whichever is later

 -ECN: 1month/2lot/1000 parts whichever is later 

-PCN: 1month/2lot/1000 parts whichever is later

 Quick removal of problem shall be done during IPC period with analysis as per the NC part handling procedure

PROCEDURE FOR INITIAL PRODUCTION PART (IPP)

PROCEDURE FOR INITIAL PRODUCTION PART(IPP)

Quantity considered for Initial Part /Pilot Lot for submitting to the customer is as required by Customer.

First Production Parts (Initial Part /Pilot Lot) are identified by special identification tag called Initial Part Tag to differentiate those from normal parts for in-house (Identified by Internal IPP Tag) and at Customer End (IPP Tag).

All Characteristics specified in drawing are checked for minimum 5 parts each lot & recorded in IPP Inspection Report & list of all Initial Parts are recorded in Initial Part Log Book.

Inspection Reports and other reports as per Customer Requirement for each initial part/lot if any is kept properly and submitted to Customer and approval is taken if required.

If Samples /IPP gets rejected by Customer, then the non-conformity procedure will be applicable and parts will be scrapped both at in-house and Customer end.

Machine used for production of Initial Parts to be identified with IPP Board.

Initial Parts to be kept away from production in lock and key condition in IPP area.

IATF16949 {8.4.2.1} Type and extent of control — supplemental

IATF16949 {8.4.2.1} Type and extent of control — supplemental

The organization shall have a documented process to identify outsourced processes and to select the types and extent of controls used to verify conformity of externally provided products, processes, and services to internal (organizational) and external customer requirements.

The process shall include the criteria and actions to escalate or reduce the types and extent of controls and development activities based on supplier performance and assessment of product, material, or service risks.

Explanation - You can refer below Procedure for Controlling Outsourced Process or Service 

What is Outsourced Process?

The process or services chooses to do with outside resource because of unavailability of resource or lack of capacity to existing resource or due to breakdown of existing resource like Production Line, Calibrations, Testing, Internal Audits, Second Party Audits, etc. will treated as a Outsourced Processes.

PROCEDURE FOR OUTSOURCED PROCESS CONTROL

Identify all such process in list of supplier and decide criteria for controlling such outsourced Product or Services or Process as per the importance, needs, risks identified , impact on quality and delivery etc.

Criteria can be 

1. Audit at Supplier Premises

2. Monitoring of Supplier Performance

3. Various feedbacks on Supply

 For selection and re-selection of outsourced supplier, follow the procedure as per Supplier Selection and Performance Monitoring Procedure.

To control the production outsourced processes, do the audit at supplier premises where outsourced process is carried out as per the Supplier Audit Procedure and ensure that the processes are within the control.

For other than manufacturing outsourced processes, ensure the control by Performance Monitoring as well taking the feedbacks on services like Testing, Calibration, Maintenance, Second party audits etc.

Ensure that the Outsourced processes or services or products are within the control limit of. if not then take necessary actions to control.

OUTSOURCE PROCESS CONTROL IN PRODUCT

0Receive planning for outsourced material processing from production department as per production requirement. Send the material for outside processing if any.

For material which is sent outside for processing shall be sent on Returnable Challan.

Receive the processed material from supplier along with Returnable delivery challan and supplier test certificate or inspection report as applicable.

Offer the material for inward inspection to QA. If the material is OK as per Incoming Control Plan/Quality Plan then shift the material in designated area along with Material Identification Tag.

If material is rejected, then shift material in Rejection area by identifying REJECTED Tag and rejection details and record details in supplier rejection register.

Communicate rejection information to supplier through mail with all rejection details and collect corrective action with root cause analysis in Supplier Corrective Action Report (8D). 

Review the supplier corrective action & Effectiveness will be verified for next three lots for identified issue. Monitor the supplier performance.

Ensure that the Outsourced processes or services or products are within the control limit of. if not then take necessary actions to control.

OUTSOURCE PROCESS CONTROL IN PRODUCT

Receive planning for outsourced material processing from production department as per production requirement. Send the material for outside processing if any.

For material which is sent outside for processing shall be sent on Returnable Challan.

Receive the processed material from supplier along with Returnable delivery challan and supplier test certificate or inspection report as applicable.

Offer the material for inward inspection to QA. If the material is OK as per Incoming Control Plan/Quality Plan then shift the material in designated area along with Material Identification Tag.

If material is rejected, then shift material in Rejection area by identifying REJECTED Tag and rejection details and record details in supplier rejection register. 

Communicate rejection information to supplier through mail with all rejection details and collect corrective action with root cause analysis in Supplier Corrective Action Report (8D). 

Review the supplier corrective action & Effectiveness will be verified for next three lots for identified issue. Monitor the supplier performance.

OUTSOURCE PROCESS CONTROL WHERE DELIVERY IS DONE DIRECTLY BY SUPPLIER TO CUSTOMER

Receive planning for outsourced material processing from production department as per production requirement. Send the material for outside processing if any. 

For material which is sent outside for processing shall be sent on Invoice

Receive supplier test certificate or inspection report for the processed material as applicable from Supplier. Verify the all reports and send confirmation to send material to Customer with Invoice.  

If material is rejected at Customer End and record details in supplier rejection register. 

Communicate rejection information to supplier through mail with all rejection details and collect corrective action with root cause analysis in Supplier Corrective Action Report (8D) and submit CAPA Report to Customer.

Review the supplier corrective action & Effectiveness will be verified for next three lots for identified issue. Monitor the supplier performance.

INITIAL PRODUCTION PART AT SUPPLIER END

Share our Development Procedure to Approved Supplier and ask them to follow same procedure for any New Product Development

Share the IPP Procedure to Approved Suppliers and ask supplier to follow as per IPP Procedure

Monitor Supplier for IPP Activities and guide them if any queries or difficulty in implementation.