Internal self-assessment for products with critical characteristics

(yearly audit according to QR83, chapter 4.3)

Supplier: Audit date:
Critical characteristics are a sub-division of special characteristics. Non-conforming critical characteristics may
result in an immediate risk to life and limb from the product or noncompliance with legal regulations (extract from
VDA Volume !.
Auditee (business unit " process!# Audit-No.#
$roduct " $roduct group# Auditor(s!#
Parts with critical characteristics (Selection)
Description (%&!' (at.-No.' (odification )ndex
Critical characteristics

Audit Result:
Number of re*uirements evaluated with +no
compliance,#
Number of re*uirements evaluated with ,predominant
compliance-
Essential audit findings / conclusions:

Actions necessary# yes no Date for action plan#
.ontainment actions necessary# yes no (see explanation on page /!
.ontainment actions implemented# yes no If not: ZF is informed
0he system review was carried out on the parts listed above. 0he supplier confirms that the system described is
used for all supplied parts with critical characteristics. .orrective actions must be completed by the set date.
Signature Auditee(s):
!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
Name " $osition#
Signature Auditor(s):
!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
Name " $osition#
"istri#ution:
ZFF VVQ Audit checli!t "or product! #ith critical characteri!tic!
QR83 Au!ga$e %&'' (age ' o" 4 )nde*: '.&
Internal self-assessment for products with critical characteristics
(yearly audit according to QR83, chapter 4.3)
Supplier: Audit date:
$ S%stematics and documents
$&$ 'here is a (rocedure for the handling of critical characteristics) which fulfill the
re*uirements of +"A ,olume $ and the ZF guideline -R./&
(anual' process - and work instructions' etc. VDA volume and 1234 are available.

full
predominant
no
compliance
$&0 'he technical documents for (roducts with critical characteristics are a,aila#le
with a ,alid modification inde1) the% are mar2ed as documents with s(ecial
archi,ing and the critical characteristics are (articularl% identified&
Drawings' technical specifications' performance specifications' re*uirement specifications' *uality assurance
agreements' inspection specifications' etc.

full
predominant
no
compliance
$&/ 'he su((lier identifies and documents also those characteristics which are not
identified as critical characteristics in the ZF documents) #ut which are regarded
as rele,ant for (roduct safet% or com(liance with legal regulations) in the conte1t
of the su((lier3s (roduct res(onsi#ilit%&

full
predominant
no
compliance
0 Personnel
0&$ 4em#ers of the management and e1ecuti,es are trained in the #asic (rinci(les of
(roduct lia#ilit%&
$roven external *ualifications about at least one member of management at 5uridical experts (seminars'
lawyers! as well as proven internal knowledge transfer. 1ualification of the process manager. 6nowledge of
national and international law (e.g. 78' 89A' :apan!

full
predominant
no
compliance
0&0 Personnel) who defines / ta2es o,er / influences / ins(ects / confirms critical
characteristics is aware of the handling and the im(ortance of (roducts with
critical characteristics) as well as of their res(onsi#ilities&
(anual' circular letter' process ; and work instructions' training certificate' etc.

full
predominant
no
compliance
0&/ 'he *ualification of (ersonnel who ins(ect critical characteristics or who are
res(onsi#le for (rocesses influencing s(ecial characteristics is (ro,en&
Defined personnel for the corresponding tasks. 0echnical *ualification' e.g. for crack detection' heat treatment'
metallurgical inspections and laboratory tests. 2egularly eye tests " ophthalmologic examinations for
personnel who execute visual inspections on critical characteristics (such as x-ray' microscope inspection'
magnaflux!. $roven by certificates or training records.

full
predominant
no
compliance
/ Products and Process
ZFF VVQ Audit checli!t "or product! #ith critical characteri!tic!
QR83 Au!ga$e %&'' (age % o" 4 )nde*: '.&
Internal self-assessment for products with critical characteristics
(yearly audit according to QR83, chapter 4.3)
Supplier: Audit date:
/&$ Critical characteristics and related (rocesses and ins(ections are mar2ed and
ade*uatel% e,aluated in the F4EA and a((ro(riate actions for (rocess assurance
are defined&
Are all processes and risks - including logistic processes and risk of permutation ; considered <
)s the level of detail ade*uate <

full
predominant
no
compliance
/&0 4anufacturing (rocesses and ins(ections for critical characteristics are clearl%
indicated in the documents for (roduction (lanning) 5control and 5monitoring&
)n control plans' inspection plans' production plans' documents' etc.

full
predominant
no
compliance
/&/ All im(ortant (roduction (arameters for critical characteristics are defined in
writing and the (roduction de,ices are (ositi,el% controlled and / or continuousl%
monitored for these (arameters ((roof)&

full
predominant
no
compliance
/&6 Process ca(a#ilit% for critical characteristics is (ro,en& If there is no (roof for
(rocess ca(a#ilit%) there are records a,aila#le a#out $778 ins(ections&

full
predominant
no
compliance
/&9 'he ins(ection methods for failure detection are ade*uate for critical
characteristics&
)nspection method' inspection fre*uency' inspection workflow' use of 9$.' inspection e*uipment with ade*uate
correctness according to the tolerance' (easurement 9ystem Analysis' inspection e*uipment monitoring etc.

full
predominant
no
compliance
/&: 'here are sufficient regulations and measures to ensure that fault% (arts are
definitel% se(arated&

full
predominant
no
compliance
6 "ocuments and records
ZFF VVQ Audit checli!t "or product! #ith critical characteri!tic!
QR83 Au!ga$e %&'' (age 3 o" 4 )nde*: '.&
Internal self-assessment for products with critical characteristics
(yearly audit according to QR83, chapter 4.3)
Supplier: Audit date:
6&$ Process documentation: 'he necessar% documents and records are defined to
(ro,ide a com(lete sur,e% of the manufactured *ualit% and are the documents
com(rehensi,e) reasona#le) (rotected against alteration and unam#iguous&
S(ecifications (describe re*uirements for (roducts and (rocesses): e.g. drawings' control plans'
inspection plans' production plans' specification of process parameters (each with distinct identification and
modification level!
Records: (give evidence that s(ecifications ha,e #een fulfilled): e.g. initial approvals' approval of
modification' inspection reports (reference " actual values!' capability studies' records about inspection
e*uipment control' audit reports' reliability tests' notes about divergent results with corrective actions (each with
distinct reference to the related product or process!.

full
predominant
no
compliance
6&0 'he documents and records concerning (roduction and ins(ection are filed safe
and according to retention (eriod&
.onsidering the re*uirements for archiving media and data processing systems according to VDA Volume .
$rotection from loss (theft' fire' water!' protection against unauthori=ed access and subse*uent modification.
$articularly protected rooms' duplicates in remote places' microfilming.
Retention (eriod for s(ecifications# > years after discontinuation of the product at %& for series- and spare
parts demand or after modification of the document.
Retention (eriod for records# > years with delivery of the product' to which the records and referring
process belong to.

full
predominant
no
compliance
6&/ 'racea#lilit% is guaranteed for (roducts with critical characteristics and the filing
s%stem allows immediate access to rele,ant documents and records&
0he filing system must enable the assignment of products and inspection documents to the lot-" batch-no.
throughout the entire production chain' including subcontractors.
$roduction period' production conditions' lot-" batch-no.' product master data' production-" delivery date'
delivery note-no' indication on the part' etc.

full
predominant
no
compliance
9 Su#contractors
9&$ Su#contractors) which influence critical characteristics) are o#liged to 2ee( ali2e
s%stematics for documented e,idence of conformit%&
e.g. contract' *uality agreement

full
predominant
no
compliance
9&0 Su#contractors) which influence critical characteristics) are e,aluated and there is
e,idence for com(liance with the re*uirements concerning critical characteristics&
e.g. inspection certificate' audit report' visit report

full
predominant
no
compliance
ZFF VVQ Audit checli!t "or product! #ith critical characteri!tic!
QR83 Au!ga$e %&'' (age 4 o" 4 )nde*: '.&