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.
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