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.