Where's the value add in product audits when your process is inspection based?

A

andrewg

#1
Help Please!!!!!!!!

Im finding it difficult to understand and grasp the thinking behind the requirement for product audits.

My company is a semi conductor firm and as such is inspection based due to demands of the customer. Our products are tested throughout the production process and at the end of process via our final inpsection process.

I understand that product audits should be independant from the line. My issue is to find a method of meeting the requirement whilst still perfoming a value add process. Any ideas?

Regards,

Andy

Can I just say, first time on this site ........... what a great idea!:mg:
 
Last edited by a moderator:
Elsmar Forum Sponsor
P

preetham - 2007

#2
meaning of product audit per TS 16949

If you are talking about the TS-16949 product audit ,its a procedure defined in the manual .in product audit we do the doc audit of the product i.e we start from the despatch section check whether all the documents are filled per the procedure manual defined as per the TS system requirement.
starting from the despatch section we will move in reverse direction step by step to the next level.so my last departmnet would be quatation enquiry.

so during product audit we check whether we have fallowed all system requirement per TS specification ,and filled all the documents per the TS manual.the product audit is only to confirm whether we have fallowed the procedures ,what we have defined in amnual .it is nothing to do with the part inspection or process inspection.
 
Last edited by a moderator:
#3
Welcome to the Cove!

Andrewg,
My product audit checklist is process based. We check the following:
  • PO Number for an order for the product
  • Reviewed per procedure? Signed off? Dated?
  • Incoming inspection for a sample part that goes into the product
  • PO Number?
  • Inspected per the procedure? Signed off? dated?
  • Work Order Number for the product
  • Documents for assembly/processing current?
  • Work Order processed per procedure?
  • Test documments processed per procedure?
  • Signed off? Dated?
  • Packaged properly for shipment?
  • ASN labels correctly processed?
  • Labeled, packaged, palletized, etc per Customer Specific Requirements?
  • Shipping paperwork per procedure and CSRs?
  • PFMEA Current?
If anyone in your production process and final test process is checking all of that, I'll eat my hat. Your product audit should check every step of your process flow as listed on your Control Plan.

Greetings preetham! Great minds think alike. What you said. Welcome to the Cove.
 
Last edited:
P

preetham - 2007

#4
i agree with the check list of icy mountain

what icy mountain has given as the check list , we have to fallow that one .
but our audit must go in revrse direction as explained in my previous reply.
first we have to start the audit from the ready to despatch part i.e nothing but the doc audit
 
#5
Good show, preetham!
Starting on the shipping dock ("dispatch" on the Continent) assures that you will have product to audit. Following the product realization process back should allow you to be able to check that all things have been completed per procedure since the product is already sitting on the dock.

Our checklist follows the flow of the product realization from start to finish. We actually fill it in from the bottom up, as preetham does. Note the addition of a check of the PFMEA. If you update and/or review your PFMEA every time you do your product audit you keep it current and avoid N/C's at surveillance
-Icy.
 
Last edited:
P

preetham - 2007

#6
reply

:) Hey andy
I think you are satisfied with the checklist provided by icy mountain.do reply us about your openion or thought
 
A

andrewg

#7
Thanks for that.

At present our products are chekced 100% inspection which is an idependant process from our production process.

We have our QA engineering department sample this inspection and make sue the inspection covers all requirements of the product. Would this meet the requirements of product audits? I understand that product auidts should be independant from the line, however I cant see how I can become proficent in inspection techniques and carry out product audits.

Comments please?

Just as a matter of interest, what industry do you guys work in? Interested in the products you make and the ease at which tests can be carried out.

Has anyone had any experience of third party audit with regards product audits?


Thanks................:confused:
 

joherjerwalla

Starting to get Involved
#8
Product Audits

Hullo
Anything which is inspected , can further be audited. Usually in a product audit the focus can be on
a) characteristics which are creating customer irritants/ complaints;
b) characteristics which are generating internal rejections/rework;
c) properties which are not routinely inspected/ nor included in the inspection/ test plan (eg.endurance test);
d) features which are verified from customers perception (eg.legibility of markings on components, quality of anti static packaging, texture/finish of components,etc).

Product audit plans can be dynamic in nature & short term -say for three months based on above. Every month these has to be reviewed for the next three months. One can also include dimensions/properties which are planned for routine inspection over & above that were referenced earlier. These is performed at the respective stages of product realization.

Product audits may not mandatorily cover all part numbers produced by you.

Product audits can be performed by the same QA team which is performing the routine inspection, however ensuring that the 'auditor' is a different person than the 'inspector' who has performed that activity.

Technical expectations of product audit methodlogy can be learnt from VDA6 part 5. English version is available. About 100 page document exist for this one subject alone.

These new requirements in ISO/TS related to product audits/ manufacturing process audits have come from the european automotive standards. These were not strongly demanded in QS9000(Americans).

Regards
Joher
Mumbai, India
 
#9
andrewg said:
Just as a matter of interest, what industry do you guys work in? Interested in the products you make and the ease at which tests can be carried out.
Has anyone had any experience of third party audit with regards product audits?
Andrew, my company makes electronics and they are 100% tested to insure funtionality. However, we don't necessarily open every box after it has been closed to make sure that we put in all the accessories, thus, a periodic audit. We don't 100% check the dimensions of the molded case. Why? Electronic function is more important to the customer, no customer complaints about size, etc. We check these things during a periodic audit.

My product audits have been examined by my 3rd party auditor at every audit so far: Pre-Audit, Registration, and 1st Surveillance. He really liked the PFMEA current? check box. If you are not auditing everything in the Control Plan you are going to have a problem.
 
S

senthilkumar

#10
preetham said:
what icy mountain has given as the check list , we have to fallow that one .
but our audit must go in revrse direction as explained in my previous reply.
first we have to start the audit from the ready to despatch part i.e nothing but the doc audit
Hello Preetham,

When you say, It must start from ready to despatch then it is only a fault finding of the work done. In this case the intent of audit i.e, 'prevention' is not met.

If you refer TS 16949 clause 8.2.2.3 it clearly says 'at appropriate stages of production'. We need to start from the starting of production to till dock. By doing so, we can eliminate any nonconformity whcih could happen at intermediate stages, by thus we need not to wait until dock stage to qualify the product is nonconforming.

I hope this how we need to interpret the standard.

Please comment.

R. Senthilkumar
 
Thread starter Similar threads Forum Replies Date
R What is a Z Value/Factor and where is it most useful? Statistical Analysis Tools, Techniques and SPC 4
P Definition S-type Tolerance - Unilateral tolerance where the desired value is 0 (zero) Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
R Where does IATF 16949 address Process mapping? IATF 16949 - Automotive Quality Systems Standard 3
C Where to place CE/label in Sterile IVD EU Medical Device Regulations 1
G New to ISO 9001 - Where to begin? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
BeaBea Interesting Discussion Where Does Marketing/ Advertisement of Products fit in to ISO 9001? Process Maps, Process Mapping and Turtle Diagrams 35
K No IFU, where the requirements would go? EU Medical Device Regulations 5
T Assessing Hazard-Related Use Scenarios where control measures exist through standards IEC 62366 - Medical Device Usability Engineering 14
J Where to Place Process Maps in our Documentation? Process Maps, Process Mapping and Turtle Diagrams 4
GreatNate Where to get a KPI dashboard for QMS processes Quality Tools, Improvement and Analysis 5
I Where can I beg, steal (just kidding of course) or borrow good training material on the ISO 9001:2015 standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
A Implementing ISO 20000-1 - Where to start Other ISO and International Standards and European Regulations 2
D Where does "as far as possible" stop? FMEA - EN 14971 ISO 14971 - Medical Device Risk Management 28
Q Statistics - Where to start in ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
H Calibration of InfraRan Vapor Analyzer - where to get calibration for SF6 General Measurement Device and Calibration Topics 2
L Clause 0.4 of ISO 9001 and EHS - Where should I stop the inclusion of EHS in my QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
M Where can I find examples of PPAP? APQP and PPAP 6
A What if Contract Manufacturers does not have an ISO 13485 certificate? Where will the NB audit take place, at legal mfg. site or contract mfg. site? Other Medical Device Regulations World-Wide 3
J Where can I find the latest update to Reach and ROHS? REACH and RoHS Conversations 7
D Where (in US) can I get the VDA Auditor Edition book? VDA Standards - Germany's Automotive Standards 3
S Where to get online AS standard audit certification classes? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
J Where I can get a copy of either the 3rd or 4th edition of UL544? Other Medical Device Regulations World-Wide 7
G Where to find Proficiency Test provider for photometrics (spectral %R, %T, photo density) General Measurement Device and Calibration Topics 9
Marc Quiz - Where did the idea of an assembly line come from? Coffee Break and Water Cooler Discussions 4
F Quality Objectives - Where in the QMS Quality Objectives should be located ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
M Where to obtain a calibrated DICOM image? ISO 13485:2016 - Medical Device Quality Management Systems 1
R Where to get information - M6 per WA900 Manufacturing and Related Processes 1
S Where did FDA 510(K) form 3654 go? Other US Medical Device Regulations 1
W Where to begin with an ISO 9001:2015 internal audit Internal Auditing 13
D China - Where I can get NMPA complete structure/organogram chart and GB/YY format list China Medical Device Regulations 1
D Where does FMEA fit in your ISO 14971 Risk Management process? ISO 14971 - Medical Device Risk Management 13
CCaantley Where to get a good test indicator stand for a granite surface plate General Measurement Device and Calibration Topics 8
I ESD - Dissipative foam on a seat for where the people sit at benches Manufacturing and Related Processes 6
C In cases where users of an electronic system change their names Qualification and Validation (including 21 CFR Part 11) 6
P Warning Letter 1999 - Where does the FDA make older warning letters available? US Food and Drug Administration (FDA) 4
Rameshwar25 Where is Personnel Safety in IATF 16949:2016 IATF 16949 - Automotive Quality Systems Standard 2
A Where are the rules for when a repeat minor nonconformance becomes a major? IATF 16949 - Automotive Quality Systems Standard 36
S Medical device mobile app UDI - Where is the UDI labelled? Other US Medical Device Regulations 1
G Where to buy Medical Grade Transformer IEC 60601 - Medical Electrical Equipment Safety Standards Series 12
Y Where can I get 14 Layers PCB with BGA 0.2MM Space? Buy, Sell or Trade - NO Commercial Advertisements 0
R ASQ, CQI,............where else ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 2
G Where to list chain of traceability? ISO 17025 related Discussions 6
M AS9100 - Where to start - Small company (10 employees) and I am the Quality Dept. AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 45
S Where to keep Enterprise Resource Planning software (ERP) Validation Records ISO 13485:2016 - Medical Device Quality Management Systems 1
H AS9100D Cert question - Small machine shop - Where can I buy a certificate? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 6
Sidney Vianna Cryptocurrencies facilitate shady deals - Where are the governance principles? The Reading Room 26
B Where do CQI Assessment requirements come into play? IATF 16949 - Automotive Quality Systems Standard 2
BradM Where knowledge and industry meet... Coffee Break and Water Cooler Discussions 10
M Plating standards - Where to find information AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
V Where to get Physical & Chemical Contaminants for for milk, beef, pork, mutton Food Safety - ISO 22000, HACCP (21 CFR 120) 1
Similar threads


















































Top Bottom