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.

IATF16949 {4.4.1.2} Product safety

IATF16949 {4.4.1.2} Product safety

The organization shall have documented processes for the management of product-safety related products and manufacturing processes, which shall include but not be limited to the following, where applicable:

a) identification by the organization of statutory and regulatory product-safety requirements;

b) customer notification of requirements in item a);

c) special approvals for design FMEA;

d) identification of product safety-related characteristics; 

Identification and controls of safety-related characteristics of product and at the point of manufacture;

f) special approval of control plans and process FMEAs:

g) reaction plans (seeSection9.1.1.1);

h) defined responsibilities, definition of escalation process and flow of information, including top management, and customer notification;

i) training identified by the organization or customer for personnel involved in product-safety related products and associated manufacturing processes;

j) changes of product or process shall be approved prior to implementation, including evaluation of potential effects on product safety from process and product changes (see ISO9001,Section8.3.6);

k) transfer of requirements with regard to product safety throughout the supply chain, including customer-designated sources(seeSection8.4.3.1);

I) product traceability by manufactured lot (at a minimum) throughout the supplychain (seeSection8.5.2.1);

m) lessons learned for new product introduction.

NOTE: Special approval is an additional approval by the function (typically the customer) that is Responsible to approve such documents with safety-related content.

Explanation - You can refer below Product Safety Procedure for Implementation.

PROCEDURE FOR MANAGEMENT OF PRODUCT SAFETY

1.  Identify & review the product safety requirements in every new product development stage, all statutory & regulatory product safety requirements as well as customers, standards input review in enquiry review checklist and feasibility analysis done for all identified characteristics.

 
2.  Prepare the list of product safety requirments which includes statutory & regulatory requirement, Customer Specification Requirements(CSR), standard requirements related to product safety, record the details in List Product safety characteristics.

 
3.  Review the product safety characteristics in control plan, FMEA as per list of product safety characteristics, Carry out the process inspection considering product safety requirement.

 
4.  Carry out the process capability study for the special characteristics and the identified characteristics related to product safety. Calculate Cp/Cpk, the values should be Cpk ≥ 1.67 or as specified by customer. If process capability not inline as per requirement, take the corrective action on identified root causes.     

 
5.  If change in product or process, review the product safety requirement at the time of change feasibility review (before change implementation stage)    

   
6.  Provide the details of product safety related to the product communicate to supplier / customer through P.O. / Specification / email

7.  Carryout product traceability through GRN No. from raw material to finish goods.

PROCEDURE FOR OPERATORS OBSERVANCE

PROCEDURE FOR OPERATORS OBSERVANCE

1.  Operator Observance shall be conducted for all operator to verify their daily working as per set standard on timely basis.

2.  Production Head shall prepare Operator Observance plan for all operators at a frequency of 1 month. 

Passing Criteria is 100 %

3.  Operator Observance shall be conducted by respective supervisor as per Operator Observance Sheet.

4.  In case of any failure retraining shall be planned on same day.

5. Effectiveness Monitoring will be done and record to be maintained in Training Attendance Sheet.

PROCEDURE FOR POISON TEST FOR VISUAL QUALITY INSPECTOR

PROCEDURE FOR POISON TEST FOR VISUAL QUALITY INSPECTOR

1.  Poison test shall be conducted for all visual inspector to verify their skill on timely basis

2.  To verify Skill,  QA Head shall prepare poison Test plan for all the visual inspector at a frequency of 1 month.

3.  Poison test shall be conducted by respective supervisor for inspector and record of test shall be maintained in Poison Test Sheet.

4.  Passing Criterion is 100%

5.  In case of any failure is observed immediate retraining shall be given and record to be kept in same training sheet.

6.  Effectiveness of training shall be verified on same day in Poison Test Sheet