SBS - The Best Value in QMS software

"Special Production Process" Validation and TS16949 Clause 7.5.2.1

D

Daniele Italy

#1
Hallo friends,

I need a clarification: are the former special process classification mentioned in the old ISO 9001 standard ( the ones than cannot be fully verified by subsequent inspections...) also valid for the ISO TS? Better, have I to distinguish for the validation of the production process between special and not special production processes using different validation methodology? Someone is telling me that also in ISO TS the validation of the non special process doesn't require any planning for re validation or doesn't require the qualification of the working personnell by using suitable check lists or exams.

Thank you for the help

daniele
 
Elsmar Forum Sponsor

Stijloor

Staff member
Super Moderator
#2
Re: "Special production process " and 7.5.2.1

Hallo friends,

I need a clarification: are the former special process classification mentioned in the old ISO 9001 standard ( the ones than cannot be fully verified by subsequent inspections...) also valid for the ISO TS? Better, have I to distinguish for the validation of the production process between special and not special production processes using different validation methodology? Someone is telling me that also in ISO TS the validation of the non special process doesn't require any planning for re validation or doesn't require the qualification of the working personnel by using suitable check lists or exams.


Thank you for the help

daniele
Daniele,

From ISO/TS 16949:2002:

7.5.2 Validation of processes for production and service provision

ISO 9001:2000, Quality management systems — Requirements

7.5.2 Validation of processes for production and service provision
The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered.
Validation shall demonstrate the ability of these processes to achieve planned results.
The organization shall establish arrangements for these processes including, as applicable
a) defined criteria for review and approval of the processes,
b) approval of equipment and qualification of personnel,
c) use of specific methods and procedures,
d) requirements for records (see 4.2.4), and
e) revalidation.


7.5.2.1 Validation of processes for production and service provision — Supplemental
The requirements of 7.5.2 shall apply to all processes for production and service provision.
7.5.2 in ISO 9001 (boxed text, blue in the quote) requires validation: where the resulting output cannot be verified by subsequent monitoring or measurement.

7.5.2.1 (automotive addition, red in the quote) eliminates that option and requires ALL processes for production and service provision to be validated. You must be able to demonstrate that these processes are able to deliver the intended outcome.

Hope this helps.

Stijloor.
 
Last edited:

Caster

An Early Cover
Trusted Information Resource
#3
Re: "Special production process " and 7.5.2.1

If you are TS 16949 and supply the "old" big 3 there are also requirements for special process assessments in the customer specific requirements documents.

These cover heat treat, painting and chroming so far.

The requirements are significant indeed.

My favorite is the very first question in the heat treat audit "name the degreed metallurgist in charge of heat treat"

Nothing went away in the change from QS to TS, the numbers just got changed and the requirements got more specific.
 
D

Daniele Italy

#5
In my side the hot potato is the crimping process where some metallic crimps are fixed on a continuous metallic wire. It is impossible to check the pulling force of the crimps during the process because of the requested integrity of the wire where the crimp are fixed ( the products are sold winded on a 2 km long spool) We are testing the last pieces of each spool and by these test the spool is validated. Is this process considered special even for the ISO 9000 ? I don't think so because some, even if few, samples are always checked... what do you think?

Is it the spot welding considered special process ?

daniele
 

Stijloor

Staff member
Super Moderator
#6
In my side the hot potato is the crimping process where some metallic crimps are fixed on a continuous metallic wire. It is impossible to check the pulling force of the crimps during the process because of the requested integrity of the wire where the crimp are fixed ( the products are sold winded on a 2 km long spool) We are testing the last pieces of each spool and by these test the spool is validated. Is this process considered special even for the ISO 9000 ? I don't think so because some, even if few, samples are always checked... what do you think?

Is it the spot welding considered special process ?

daniele
Daniele,

I am not a crimping expert, so you'll have to see how others respond.

I would consider spot welding a "special process" because the integrity of the weld can only be checked through a destructive test. So yes, this process should be validated.

Stijloor.
 
Thread starter Similar threads Forum Replies Date
Techilady Ford Special Characteristics Communication and Agreement Form (SCCAF) provides production requirements? FMEA and Control Plans 4
W Special Characteristic Control in Production IATF 16949 - Automotive Quality Systems Standard 1
John C. Abnet Special Status Notification IATF 16949 - Automotive Quality Systems Standard 1
D Special IATF audit of sub-supplier IATF 16949 - Automotive Quality Systems Standard 5
A IRIS audit - Discussion about Special Processes General Auditing Discussions 11
S SOP Identification of Special Characteristics IATF 16949 - Automotive Quality Systems Standard 6
B AS9102 - 3D printing a special tool required for assembly (counterfeit risk?) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
Nihls MSA Study Type 2 (special conditions ) IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
R Critical Characteristics & Special Characteristics FMEA and Control Plans 2
P Letter to file or special 510k or traditional 510k 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S OEM full range calibrations vs Validation special test points Medical Device and FDA Regulations and Standards News 1
G Special 510K possible? Only the packaging has changed Other US Medical Device Regulations 0
S Special 510(k) for orthopedic implant 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
N Riveting - special process Manufacturing and Related Processes 11
H AS9100D clause 8.5.1 f) & 8.5.1 g) - Special Processes AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
C AIAG-VDA PFMEA - 1st special Characteristics? [5step vs. 6step] FMEA and Control Plans 3
J 1.11 Preliminary Identification of Special Product and Process Characteristics APQP and PPAP 4
earl62 What is the best way to control special characteristics in Control plan? Is it Mandatory to have SPC for IATF 16949? IATF 16949 - Automotive Quality Systems Standard 12
Y What are different Special Inspection Level 1-4 and General spesification 1-3 ? AQL - Acceptable Quality Level 0
L Special Processes for SERVICES AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
K PSA Special characteristics Customer and Company Specific Requirements 0
Watchcat Advantages to pursuing a Special 510(k) instead of a Traditional 510(k) Other US Medical Device Regulations 5
qualprod Managing a "special" customer into the QMS? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
S Special 510(K) - Labeling change from Rx to OTC Other US Medical Device Regulations 11
M Special Controls and Class II Medical Devices Medical Device and FDA Regulations and Standards News 18
A ISO 10993-7:2008/ Amd.1:2019 - Classification of special populations Other Medical Device Related Standards 8
H SPC for special characteristics - CSR - Control of SC and CC Statistical Analysis Tools, Techniques and SPC 1
L Special Processes - Technical reason concerning torque - Anaerobic compounds Manufacturing and Related Processes 10
M Informational US FDA Final Guidance – Special Premarket Notification [510(k)] Pathway Medical Device and FDA Regulations and Standards News 0
F Replacement Bone Screws - Traditional 510(k) or Special 510(k)? Other US Medical Device Regulations 7
F Assignment of Special Characteristics to government regulations IATF 16949 - Automotive Quality Systems Standard 5
qualprod ISO 9001:2015 8.5.1 f - Scope with customer special process requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
J ISO 13485 - 7.5.2 cleanliness , 6.4.2 validation of special processes, and 6.4.2 contamination ability to be exempt? ISO 13485:2016 - Medical Device Quality Management Systems 5
L Injection Moulding Process (Special Process) Validation Food Safety - ISO 22000, HACCP (21 CFR 120) 2
S The key differences in 510k types - Traditional vs. Abbreviated vs. Special US Food and Drug Administration (FDA) 0
D I'm new in IMDS special using the IMDS application Manufacturing and Related Processes 8
S VW Special status condition IATF 16949 - Automotive Quality Systems Standard 3
K Letter to file vs Special 510 for additional accessory in orthopaedic kit Other US Medical Device Regulations 1
P Special 510(k) - Modified Medical Device Description Other US Medical Device Regulations 8
P V&V for Special 510k 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
F CQI-23 Special Process Molding - Controls IATF 16949 - Automotive Quality Systems Standard 7
B AS9100 - Are special process suppliers required to be NADCAP accredited? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 15
A Non-destructive testing methods are special processes? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 18
P Sanctioned Interpretations - IATF 16949 Cl. 8.3.3.3 Special characteristics IATF 16949 - Automotive Quality Systems Standard 3
E IATF 16949 Cl. 8.2.3.1.2 - Customer-designated special characteristics IATF 16949 - Automotive Quality Systems Standard 1
T Customer special status and initial IATF certification IATF 16949 - Automotive Quality Systems Standard 12
J NADCAP - Supplier Special Processes Certifications Manufacturing and Related Processes 1
N Special Vs Non-Special Processes Misc. Quality Assurance and Business Systems Related Topics 24
D Customer-Designated Special Characteristics vs. Special Characteristics IATF 16949 - Automotive Quality Systems Standard 2
S IATF 16949 Clause 8.3.3.3 - Documentation of all Special Characteristics in Drawings IATF 16949 - Automotive Quality Systems Standard 2

Similar threads

Top Bottom