Purpose :
To establish a procedure for the management of product safety-related products and manufacturing processes. Ensure that product safety requirements are considered during development and regular production.
Scope :
Applicable for all products and manufacturing processes where safety requirements need to be considered.
Responsibility :
Head development is responsible for fulfilling all these activities during development. Head production and QA are responsible during regular production.
Product Safety Procedure :
Identification of product safety requirements :
Product safety requirements are identified at the time of development through the following inputs
- Requirements specified in Customer Drawing
- During the development of PFMEA.
Special Characteristics in documents :
Identified Special Characteristics are incorporated into the following process and Product control documents. All these are communicated down the level through display and issue of documents. Also, identify statutory and regulatory product safety requirements.
- Control Plan
- Operation Standard
- Work Instructions
Information to Customer :
Where required, customers are notified about the safety requirements. If any specific test is to be carried out the same is carried out and reports are submitted to the customer as applicable.
Documents special approval :
Head QA approves the Control Plan with special product and process characteristics. To ensure adequate controls have been established including a specific reaction plan at the point of manufacture. If required by the customer, the Control Plan & PFMEA are approved by the Customer.
Training:
Proper training shall be provided for the person involved in a special product and manufacturing process. The minimum skill required to work in the special product and manufacturing process is Level 3 (Skill Matrix)
Any product safety failure identified in the line should first be reported to the head QA. Also looking at the seriousness it is communicated to customers.
Change approval :
Whenever any change in product characteristics or manufacturing process, approval of the change is taken from the customer. Also change implementation is done in production as per ECN procedure.
Information to the supplier :
All the product safety requirements as applicable to the supplier are communicated through Drawing/PO/E-mail/Specification review meetings. Compliance with the same is verified through supplier test reports, Incoming Inspection Reports & PPAP Approval.
Identification and Traceability :
Traceability of part is identified through a unique lot number/batch code through the procedure for Identification and traceability.
Past Trouble Data Sheet :
During the development (NPD) and as well regular production whatever the problems faced. All are captured in the past trouble data sheet ( Lesson learned sheet ) and used for future developments.
4.4.1.2 Product Safety:
The organization shall have documented processes for the management of product safety-related products and manufacturing processes.
- Identification by the organization of statutory and regulatory product safety requirements.
- Customer notification of requirements
- Special approval for design FMEA.
- Identification of product safety-related characteristics.
- Identification and control of safety-related characteristics of a product and at the point of manufacture.
- Special approval of Control Plans and Process FMEA.
- Reaction Plan
- Defined responsibilities, the definition of the escalation process and flow of information including top management and customer notification.
- Training identified by the organization or customer for personnel involved in product safety-related products and associated manufacturing processes.
- Changes in product or process shall be approved before implementation, including evaluation of the potential effect on product safety from process and product changes.
- Transfer of requirements about product safety throughout the supply chain, including customer-designed sources.
- Product traceability by manufactured lot (at a minimum) throughout the supply chain.
- Lesson learned for new product introduction.
Reference: IATF 16949 Standard