Points
10
Product risks
Product is free from complaints andmeets all technical requirements
Process risks
Technical requirements/specificationscovering product and process are met
QM System relevance
● Record show that QMS isimplemented in practice
● Target requirements are achieved
8
● Requirements/Documentation ofresults have loopholes in individual
● Minor problems in the production
pointsComplaints regarding the product,but no
process
effect on function,use or further process● Corrections requried to test/inspection
● Process weaknesses are present but
operation. Improvement requiredrequirements or production parameters
are detected and eliminated immediately
● Target requirements not met inindividual cases● Complaints regarding the product,noeffect on function,but defect leads toproblems in use or further processoperation
● Process capability(Significantcharacteristics) is not achieved
● Defects are reworked in follow-onprocess
● Defects are detected by
monitoring,non-conformities must besecurely removed from process
operations,separated rework required
● Products can't be made in a secureprocess,however significant
characteristics are within specification● Significant charateristics are notmonitored systematically● Sorting action required● Rework required
● Risk of damage to parts
● Process problems in overall flow ofmaterials
● Insp./Measurement Equipment notsuitable for detecting the defect
● Employees have not been adequatelyinformed
6
● QMS is not implemented correctly inline with requirements
● Process control is not carried outcorrectly
● Effectiveness of actions is notchecked
● Inadequate preparation of data formanagement information● Company-wide targets are
met;serious deviations from internaltargets
4
● Products can't be made in a secureprocess,significant characteristics are● Complaints regarding the product
partly out of toleranceaffect
● Charateristics are not monitoredfunction,defect leads to restrictions in
use and have significant effects in furthersystematicallyprocessing● Sorting action required● Agreed process capability(special● Rework requiredcharateristics) is not achieved● Risk of damage to parts● Defects lead to serious process● Mixed-up parts/incorrect assemblydifficultiesleads to process problems● Defects are not guaranteed to be● Insp./Measurement Equipments fordetected,sorted or reworked in follow-ondetecting deviating charateristics are notprocessessuitable● High scrap levels and/or extensive● Employees are neither adequatelyseparate rework requiredtrained nor been informed of the defect
pattern● Machines,facilities and/or jigs&fixturesare unsuitable,incomplete or missing● Complaints regarding the
altogetherproduct(function no longer
guaranteed,use of the product is● Customer relevant charateristics can'tsignificantly restricted,further processingbe achieved as a secure processby customer is not possibly● Checks,insp./measurement● Defects not detected,sorted orequipments to monitor customer relatedreworked in follow-on processescharacteristics are not present● Rejects or field returns is to be● Damage to customer relevantexpectedcharacteristics caused by parts handling● Use of the product may represent a● Mix-up parts in-house or whendanger to the usershipped restrict further processing by
customer
● Production parameters/Insp.
Requirements not set out in regulations● Improvement programs notintroduced
● Effectiveness of improvementprograms not demonstrated
● Severe deviations from company-wideand internal targets
● Inadequate compliance with
requirements for critical charateristics
0
● Personnel training for groups is notcarried out
● Inadequate compliance with
requirements leads to functional failuresfor customer
Rules:
● Immediate actions must be specified and implemented if there is assessment 0 or 4.The auditor must assure
him/herself of the effectiveness.
● The entire chain must be checked if there is assessment 0 and suspect parts shall not be shipped.
● The scenarios in the above are merely framework examples.They are not always entirely applicable and may also beextended if required.
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