06 Section 19 Definition: 06.1 The safety aspects of a product should bc identified, with the aim of enhancing product safety.

The quality system must Mways be directed towards the reliable prevention of nonconfcrrnities. The employees of a coolpany, particularly executkve/ management pesonnel, must, ki accordance with their activities, be appm priately informed of the effects of prDduct nonconformities and the contequences for the company arising from product liability.
Note. VDA Volume I is also applicb4e far Ibis &leneril

Product Safety DIN EN ISO 9004-1

Are the principles of ptoduct liability known throughout the company?

Product Yabilily (according lo DIN EN /SO 340212.12):

A genenc term used to describe the Onus c. a producer or others to make restitution & bss related to peitscaa inftny, properly damage or other harm caused by a product
Nd,:

The ega) and hnanci.i impcation ol p.aduc1 liability nay vary horn one juo.diction to onoihec.

Requirements/Explanation:

Indications concer&n 0 the knowledge of the principles of product liability can be, amongst others, evidence of:
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instruction and qual&alion of responsible irdivtuals Lga services (intemai / external) Product liability Insurance Observation of science and technology

Product safety deficiencies can lead to liability claims against the company. Therefore, the company employees. particularry the management per so:niol. in accordance with their activities must have appropriate knowledge of tile principles & product liabity. Reference DIN EN SO 9004-1 9001 06.1
DC Prrc

pies of product iiabiity

are

(amongst others):

Arc the prhiclpies of product liability known throughout the company?

(4.2.3 ag)

19
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06.2
06 4

Have procedures far identifying product risks

19b
Do emergency plans and procedures for containing nonoanforwing products exist?
(4S) 19d.

Liability dependent on blame (characterized by the reversal of the burden of pmof. i.e. the burden 0! proof lies wllh the deferdarit) Liability independent of bisine (new product liability law), liability for direct damages and coisequenliS dama es tajs,d by a 9 d eted it must be demonstrated that the manufacturing process (design. manufaduring and tastkig) is state of the arI simply coiiplying with the applicable standards is not sufficient Responsibilities must be defined In writing Inspection and testing documentation with archiving Traceability must be ensued (limitation of dama es) 9 Warning of pcsiblc risks when the product is put into aclion by Mc user.

05 .2

Is theN a procedure to define and identity products and spe cial characteristics, for which special documented evidence of the quality Is requIred?

A retention period of 15 years (differences spedfled4 the customer must be taken itt account) is also valid after discontinu& Cf production (for further isfrirtiors, see VDA Volume I).

Explanation of terms Products end chsracteristcs, with require the corresponding documen tation to be specially archived, have either special si9niftance for functional safety (operation and use) or are diecily subject to requiremerlis derived from official specifitations (see VDA, Volume 1). All products wilh at least one such characterisit require documentation with special archiving. 6.V Their special treatnent is based en general and specific safety standards elated to the slated the an and customer requiremcnl& Requlremenls/Cxptanatlon: The system should take intc cortideralion. for example: Recogrtion of product risks (set question 06.3) Derihon of the ctaracterlsl cs concerned 1 Identification of these characteristics on aN relevant documents Identification and handlIng of these prodbcts Documentation system with rules for reIenton periods and responsibilities The documentation includes, for example. Test results, test decisions, process parameters Records ci the calibration of test equipment Records of the instruction, knowled9e, competence and suitability of personnel (eg medical examinations, such, as eye tests) Special processes for products with characteristics subject to documentation. Al documerts which relate to s. a characteristic must be specially identi fiecL Departments involved must be informed about the need icr special handling of these doci.tents.

Proper documentation can conirtute towards exoneration in warranty and product lability cases.

The company obligates hsell with the order confirmation to tolcw the appropriate procedure, if agreed.

Have procedures for Identifying product ilsks been deiired? Eicplanatlon of terms:

HPjtduct Risks are safety iisks that are involved in the product tulUhlin We own function Furthermore, this also refers to the Hsks that a component brings Ia a complete assembly. Require ments/ExpI a net Ion:

Product risks are identifiable through: for exaopler

Risk ania:yses (FMEA. songst others: Load-bearing tests Service lie tests Crash tests Material testing Installation blals Environmental simulation tesis Investigations of environmental compatibility and disposal

and the derived measures resulting from these.

The safety aspects are of predominant impedance during these exami naiioflR.

The applicthle procedures serve to identity and estimate the oiential dangers, which arise from an incorrectly developed, manufactursd and/or described product, if necessary, they must lead to decisions regaring actions to be tthen

This applies equally to product desccipbons eg. manuals).

O&4 Do emergency plans and procedutn for containing fonning products exist?

noncon

E.xplanation of terms:
Procedures to contain
nonconForming

items serve darrage Urnitatlan.

They facilitate the Iraceablifty of products In a manufacturing operation back to the material arid processes used. Requirements/Explanation: Emergency plans for product recalls must be defined commensurate with the product risks, which are dedved from the safely relevance of a product and possible risks in the entire process chain. Procedures to contain nonconforming pmducts (see aiso Questions 11.7 and 11.6). for example. tan be:
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Identification on the partipfoduct Lot/batch identification Product werificalion, documentation Product identification during transport arid storage Following the lirst-inffirsl-out principle Statin9 and observing use-by dates

Recognized nonconformities which are relevant to safely can thereby be limited (damage imitation) in the field (during use) and possibly remedied by improvement or retail actions.