Special Vs Non-Special Processes

Elsmar Forum Sponsor

Big Jim

Super Moderator
#12
I had thought that ISO 9000 defined special processes but I have not been able to find it today. Although it is a different standard, AS9100 does mention special processes. In AS9100B and AS9100C it was in an aerospace enhancement note to 7.5.2 simply stating that these processes (the ones that cannot be verified by ordinary means) were also known as special processes.

In AS9100D the note remains where they are first addressed in 8.5.1f. 8.5.1f also directs the reader to 8.5.1.2 where essentially aerospace restored the wording from ISO 9001:2008 and AS9100B/C. ISO 9001 had streamlined the requirement, mainly removing the requirement to keep records. AS9100D brought it all back. 8.5.1.2 reinforces the topic by titling it "Validation and Control of Special Processes".

Core to both the older wording and what is not in AS9100D 8.5.1.2 is "For processes where the resulting output cannot be verified by subsequent monitoring or measurement, the organization shall establish arrangements for these processes . . . "

In brief, if you can't verify it, you need to validate it.

Although it is not the standard you are dealing with, you may find more insight searching in the AS9100 literature.
 

Tagin

Trusted Information Resource
#13
Thanks.
By the way, there is no definition of special processes in ISO documents?
In ISO 9000:2015, it is a note attached to the definition of 'process':
process
set of interrelated or interacting activities that use inputs to deliver an intended result
...
Note 5 to entry: A process where the conformity (3.6.11) of the resulting output cannot be readily or economically validated is frequently referred to as a “special process”.
 
Thread starter Similar threads Forum Replies Date
A Non-destructive testing methods are special processes? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 18
A Special Procedures for Non Aerospace Customers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
D Control charts for non-normal distributions - Do I need to do anything special? Statistical Analysis Tools, Techniques and SPC 5
samer Oracle computer records - Special procedure for dealing with non-paper Records? Records and Data - Quality, Legal and Other Evidence 2
Techilady Ford Special Characteristics Communication and Agreement Form (SCCAF) provides production requirements? FMEA and Control Plans 4
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 0
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 3
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
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
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
M AS9110C Clause 8.5.1.2 Validation and Control of Special Processes for Repair Station AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
C AS9102 Form 2 Information - Special Processes - Plating AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
S Metal Radiographic and Ultrasonic Testing - Special Processes AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
M Special Characteristic - IATF Definition IATF 16949 - Automotive Quality Systems Standard 4
W AS9100D Clause 8.5.1.2 Validation and Control of Special Processes AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 37

Similar threads

Top Bottom