Product Safety Management Manual - Rev 4 Date 10.05.2013 -
Revision Index Revision no Change description Date 0 Initial release 30.12.2008 1 Part identification guidelines for traceability 25.07.2009 included 2 Flow chart for Forward & Reverse traceability 30.10.2009 of supplier parts included Supplier process change control added 3 Company name WABCO-TVS has been 15.09.2011 changed to WABCO INDIA LIMITED (WIN) 4 Safety and significant characteristics CpK report submission by Suppliers in Supplier web portal added. 10.05.2013 1
Preface WABCO INDIA LIMITED (WIN) being involved in developing, manufacturing and selling products for heavy / light commercial vehicles and utility vehicles such as braking system, vacuum brake valves and electronic braking system, the quality of which plays a vital role in terms of vehicles safety. WIN has evolved the Safety strategy and striving to achieve excellence in Product Safety. It is being ensured that the various processes involved in the manufacture of the products comply with Product Safety Management requirements. It is also essential that the same has to be extended to Suppliers supplying various components being fitted into the assembly. The purpose of this manual is to define the Product Safety management requirements which will be useful to suppliers in implementing. 2
CONTENTS Page no 1. Objective 4 2. Scope 4 3. Product Safety Management Overview 4 4. Safety, Significant characteristics 5 5. General awareness Training 7 6. Process design for Zero defect 7 7. Process Machine capability 7 8. Machine maintenance 7 9. Customer application 8 10. Control of Tools, dies, fixtures 8 11. Visual management identification 9 12. Control plan 9 13. Measurement system Analysis 10 14. Management of nonconformities 10 15. Control of rework 11 16. Material traceability 11 17. Identification of safety component suppliers 18 18. Deployment for Tier n suppliers 18 19. Control of changes 18 3
20. Manufacturing at Tier 2 suppliers 19 1.0 Objective of this Manual: To spell out the various requirements of Product Safety Management through this manual so that the suppliers understands and become aware of the requirements, implement the same in their manufacturing process ensuring defect free supplies which forms a part of the Safe Product 2.0 Scope: This is applicable to all Direct material Suppliers 3.0 Product Safety Management: The term Product Safety Management refers to the set of activities which the supplier shall implement at their end which will ensure end customer expectations such as - Quality of the product and Service Zero rejection at customer end - Safety of the truck / vehicle - Zero downtime to accomplish JIT deliveries - Immediate response at an issue - Durability and high residual value Thus, a truck / vehicle could not lost the control or afford unscheduled stops for a reason of a defective component supplied by a supplier 4
4.0 Safety, Significant Characteristics: WIN identifies Safety significant characteristics during system, component, and process design. The logic of identifying safety characteristic and significant characteristic is as shown below in the flowchart Characteristics with requirements from legal regulations Definition of Safety Characteristics by customer Definition of Significant Characteristics by customer Results of tests and simulations System FMEA Design FMEA Characteristics with S=10 or Vehicle breakdown Yes Identified and marked as Safety Characteristic <1> No Characteristics with S=9,8,7 or no fit on vehicle or noticeable defect with immediate need for repair Yes Identified and marked as Significant Characteristic <2> No No marking 4.1 Safety Product characteristics Definition <1> Even that can lead injury at people 5
Risk of injury Can affect the product safety or legal consideration 4.2 Significant product characteristics Definition <2> Characteristic that is important for customer Can affect customer satisfaction Loose of principles functions of the device Breakdown, repairing, ability of the product, stability A sample of the drawing shown Safety product characteristics and significant product characteristics is shown below - Safety product characteristics - Significant product characteristics 6
It is essential that suppliers shall maintain a master list of Safety significant characteristics. 5.0 General awareness Training: WIN conducts periodical training program on product safety. Suppliers shall nominate persons and get trained. They in-turn can train their in-house employees, new recruits and temporary trainees in their own organization. The training programs are conducted to develop and maintain the knowledge on product safety and liability. It is also the responsibility of the supplier to train Tier n suppliers so that they are well aware of product safety requirements 6.0 Process design for Zero defect: The supplier shall design and carryout processes which will ensure Zero defect. The supplier shall also maintain all safety significant characteristics and processes under control - Cpk meets or exceed Cpk target (>1,67) - Design and process poka yoke - Auto-detection systems combined with containment of defective products The supplier shall not alter any process without prior approval obtained from WABCO INDIA 7.0 Process and machine capability Supplier shall ensure that Statistical process control techniques are being used in the safety machines, workstations to constantly check the process capability. The stability of the process parameter shall be demonstrated through SPC charts and shall be monitored. Supplier shall upload every month s <1> and <2>, Critical and Major Characteristics CpK report in www.wabcoindiaportal.com (supplier web portal) on 7
or before 5 th of following month. CpK report submission status will appear in WABCO in-coming inspection GRN tag, and the parts will be accepted only if CpK report is received on time. 8.0 Machine maintenance: The machines which are used for manufacturing safety products shall have high equipment efficiency in order to avoid any substitution. It is essential that the machine and equipments related to product safety operations are highlighted in the maintenance plan. There should be delay on maintenance operations for safety critical related equipments. The maintenance people are well trained in product safety and related specific instructions 9.0 Customer application: Supplier shall ensure that the components manufactured are being handled safe. Necessary protective arrangements / dedicated containers / packaging shall be ensured at the appropriate level to avoid any damages on safety significant characteristics. The supplier shall ensure the above throughout the supply chain. For example a threaded component manufactured by a supplier transferred to heat treatment and surface protection operation has to be protected against thread damage which is a customer end fitting shall be handled safe by providing appropriate in-house dedicated containers, covered with protection sleeve during the transit and dispatch Raw material Supplier Supplier A Tier 2 Supplier Heat treatment 8
Tier 3 Supplier Surface protection 10.0 Control of Tools, Dies and Fixtures: The supplier shall have a system of monitoring tool life, periodical Inspection and calibration of Jigs and fixtures used in the manufacturing of safety products. 11.0 Visual Management Identification: There shall be a specific identification on Product safety for dedicated manufacturing or workstations, Safety characteristics on manufacturing documentation. Product safety workstations and manufacturing documentation are audited periodically and updated regularly based on the experience 9
12.0 Control Plan: The supplier shall ensure that control plans are defined and suitable for all safety characteristics. The controls plans shall be audited periodically (once in 6 months) and updated regularly according to the experience. In case of any change in the process, the supplier shall submit updated control plan and get prior approval from WIN without which any change would not come into effect. The supplier shall also produce the control plan documents to WIN auditors during the PPAP audit 13.0 Measurement System Analysis: The supplier shall establish a process to evaluate the reproducibility and the repeatability of each measurement done on safety characteristics. R&R measurements are done and master samples to evaluate the conformity of the testers are made available. 14.0 Management of non conformities: The supplier shall establish process to manage non conformity on Safety characteristics including secured identification and defective part isolation. A robust fire fall process is implemented to secure product and the critical safety failed parameter. There shall be an evidence of the application of the control of non conformity rules with focus on safety critical characteristics which will be audited periodically Upon receipt of any customer complaint or If there is any quality problem which is detected in manufacturing process / subsequent process / at Tier 2 supplier end / final inspection on safety significant characteristics the supplier shall carryout the following 1. To stop the manufacturing process immediately. 2. To analyse the root cause of the problem and take corrective / preventive action. Problem resolution process (PRP) model can be followed. 10
3. The WIP stock in the entire pipe line shall be quarantined, check for the defect observed and the defective component shall be segregated, only on successful pass the manufacturing / supplies shall be effected 15.0 Control of Rework: The supplier shall ensure that there is a systematic check after rework with the same tools and process as the standard one, with specific identification and traceability. The supplier shall evolve and work on a plan to reduce rework thereafter No rework would be carried out and the defective component will be scrapped 16.0 Material traceability: The supplier shall have adequate traceability right from the receipt of the raw material, storage, and work in process, and on the finished component. The information on the materials shall be retained for a minimum of 10 years. FIFO shall be ensured and mixing of batches shall be avoided. The supplier shall ensure the supplied components are identified with Identification tag. Also supplier shall follow traceability guideline to ensure component level traceability. This is mandatory for the components with safety <1> characteristics in drawing. The supplier shall discuss with WIN for location in the part for providing these details, if this has not been specified in the drawing. The complete flow chart for the forward & reverse traceability of supplier component is as follows. 11
. Reverse Traceability of Supplier parts (Assembly to supplier raw material) Process Flow Traceability Action End customer Affix date and shift of manufacture Manufacture assembly Store in RM stores and transfer to WIP Supply material Generate Delivery challan Customer complaint received Identify Date and shift of assembly Identify defective supplier part Trace back to the WIP transfer document for the day Find out the GRN number from Header text Find out the Challan number, supplier Quarantine Customer end Quarantine WABCO sales ware house assembly stock Quarantine WABCO stores stock Manufacture component Prepare route card on receipt of raw material Trace back to route card number, raw material receipt Trace back to batch and challans supplied Route card Route card Quarantine supplier in-house stock RM Supplier 12
Forward Traceability of Supplier parts (Supplier raw material to Assembly) Process Flow Traceability Action End customer Inform to Sales warehouse / Customer Quarantine Customer end stock Affix date and shift of manufacture Identify date & shift of Suspected batch of assembly Block the suspected assembly ready for dispatch to Customer Manufacture assembly Trace back to the WIP transfer document for the day Store in RM stores and transfer to WIP Find out the GRN number from Header text Quarantine WABCO stores stock Supply material Inform WABCO about suspected DC numbers Generate Delivery challan Find out the Delivery Challan number from the route card Manufacture component Trace back to route card number, raw material receipt Route card Block the suspected component ready for dispatch to WABCO Prepare route card on receipt of raw material Problem found in a Production batch at supplier end Route card RM Supplier 13
The Part level identification guidelines for traceability is explained below 14
15
16
17
17.0 Identification of safety component suppliers: 18
The supplier shall maintain a list of outsourced safety parts and / or safety critical operations with identification of related Tier suppliers which are regularly updated. The supplier shall also ensure that tier supplier is competent enough in making the safety parts. 18.0 Deployment for Tier n suppliers: The supplier shall work on a documented action plan with Tier n suppliers with specific targets. It is also the responsibility of the supplier to evaluate and monitor their performance and ensure that the tier suppliers are improving their performance and have reached the target level. WIN will provide the necessary support in achieving the same. 19.0 Control of Changes: In case of any product / process change, the supplier shall submit a written request to WIN to obtain approval in prior to implement the change. The following are some of the change cases. Addition or change of Tier n suppliers Replacement / Modification of tooling or Equipment Production process Rearrangement Production process transferred to a different location Tooling inactive for twelve months or more Change in Logistical parameters including packaging Change in test/inspection method Use of alternate material WIN will decide for the PPAP requirements, Customer approval, and Product / process validation. Changes shall not be implemented prior to the receipt of written approval from WIN. 19
20.0 Manufacturing at Tier 2 suppliers: The supplier shall ensure that Tier 2 suppliers manufacture safety critical characteristics confirming to required Cpk level and statistical process control is in place. It is the responsibility of the supplier to carry out audit at Tier 2 supplier and improve 20