Are Product Special Characteristic(s) Mandatory?

jelly1921

Quite Involved in Discussions
#1
8.3.5.1 Design and development outputs - supplemental
The product design output shall include but is not limited to the following, as applicable:
c) product special characteristics;

From this clause, we can conclude that there is or not the product SC after the product design and development.

But
8.3.5.2 Manufacturing process design output
The manufacturing process design output shall include but is not limited to the following:
b) special characteristics for product and manufacturing process;

Can we infer that product SC must be identified as an output of manufacturing process design?

:thanx:

Jelly
 
Elsmar Forum Sponsor
R

randomname

#2
Product SC will be identified as part of product design. However, often the process characteristics that control those product SCs are sometimes then identified as part of process design.

However, note it says "as appropriate." So it depends on what is designed/produced ... are some characteristics critical? If so, identify which ones. If not, don't.

Think of it as risk based thinking.
 

Golfman25

Trusted Information Resource
#3
Frankly there is a lot of auditor bs in this area. Some say you must have something. Others say, it depends.

SC should be identified in design. What is important and what isn't. So you may decide a diameter is a SC. When you put your manufacturing process together, you flow that SC down to your process. If the design people don't identify SC, it should not be on the manufacturing people to make them up.
 
N

ncwalker

#5
The real answer is it is both. And it is an output of FMEA, but BOTH of them.

The design group conducts the DFMEA and this will identify special characteristics based on the function of the product. ALL of these a transferred to the PFMEA and handled appropriately. If there are none, then none need to be created.

BUT ...

It is also totally appropriate that if when the manufacturing types are conducting the PFMEA they mark additional SC as they see fit. These are not determined by "critical to function" but rather by "key to control the process." And they are free to add any that help them manufacture better, but there is no requirement that they create some just to have some ...

How about some examples? Sure - no problem.

Example 1: Almost ANY molding process with a parting line. In any molding process, you want to ensure the halves of the mold are brought together in the same way each and every time. There may be a pair of surfaces that cross the parting line that are very easy to measure with calipers or some automated transducer that have nothing to do with the design or functionality. This is a good candidate for a manufacturing SC because it is a) easy to measure and b) describes a key part of the process that needs control and monitoring.

Example 2: Any sort of induction or coil based mechatronix device. After you wind your coil you may want to do a simple continuity check (to make sure your wires are varnished) OR a B-field magnetic check. Point is - some check on the coil itself that makes sure it's healthy before all the other components are added to the circuit (which may make it impossible to diagnose the coil alone).

Example 3: Some intermediate machining step. Let's say you are going to establish some datums and further on, you initial datums are removed. You may need to mark some intermediate features as SCs even if they are machined away at a later time. The goal here being cull scrap as soon as possible. If you don't, you machine it later. And running a bad part completely through a process is expensive.

If you have your auditor telling you that you MUST have them, the auditor is wrong. It's really a financial decision, honestly. What are you willing to do to NOT send bad parts?

If you say there are none in the manufacturing process, I would caution you to look again. In very few cases I have seen has there been no reason (primarily due to OEE reasons) to not have SOME in process monitoring done on things that don't directly connect to the final design.
 
Thread starter Similar threads Forum Replies Date
J 1.11 Preliminary Identification of Special Product and Process Characteristics APQP and PPAP 4
R QS-9000 Clause 4.2.5.1 Continuous Improvement of Product Special Characterisitics Preventive Action and Continuous Improvement 4
H Product Safety & Conformity Representative (PSCR) Training Company IATF 16949 - Automotive Quality Systems Standard 0
X Design stage overview (Product specification) EU Medical Device Regulations 3
9 Responsibility for Product Paid for but not yet Shipped AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
M Product Acceptance Software (PAS) PROCEDURE (BOEING D6-51991) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
S Combo Product Assembly Process OQ Qualification and Validation (including 21 CFR Part 11) 0
V ADDING NEW MEDICAL DEVICE / Product, WHEATHER THIS AFFECTS EXISTING ISO 13485 CERTIFICATION? ISO 13485:2016 - Medical Device Quality Management Systems 4
A Product Liability Insurance coverage for EU Importer by UK Manufacturer EU Medical Device Regulations 2
sonflowerinwales Outgassing - product inside a sealed housing Manufacturing and Related Processes 1
L Temporary Product Deviation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
FRA 2 FDA Product NCRs- Quality Review Nonconformance and Corrective Action 6
armani 7.1.5 and design and development of product ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
M Aftermarket product PPAP approval IATF 16949 - Automotive Quality Systems Standard 1
G How to find applicable standards for a new product? EU Medical Device Regulations 3
T Link GMDN code and FDA product code US Medical Device Regulations 5
S Combination Product - Packaging US Food and Drug Administration (FDA) 6
S Can a product option change the product class? CE Marking (Conformité Européene) / CB Scheme 2
H Regarding EMC & Safety retesting requirements of the product CE Marking (Conformité Européene) / CB Scheme 2
Q Product audit assessment IATF 16949 - Automotive Quality Systems Standard 4
S Submit under a new product code in a 510k? US Medical Device Regulations 5
P Product Quality Review API-GMP Manufacturing and Related Processes 0
D Shelf life of non sterile class IIb product. ISO 13485:2016 - Medical Device Quality Management Systems 1
A Product Update and executing only affected System Tests, leaving out unaffected ones IEC 62304 - Medical Device Software Life Cycle Processes 5
K Can I make an exclusion of Design and Development in ISO 13485:2016 if my product is not regulated ISO 13485:2016 - Medical Device Quality Management Systems 12
M How to show the effect of the failure mode on the manufacturing process as a customer of product design process? FMEA and Control Plans 3
J Enough for PSUR to cover product family? (Procedure packs, not the legal manufacturer) EU Medical Device Regulations 1
B Product registration CE Marking (Conformité Européene) / CB Scheme 2
V Product naming: Same name - different perfume & status CE Marking (Conformité Européene) / CB Scheme 0
E Marketing, product and system requirements IEC 62304 - Medical Device Software Life Cycle Processes 2
C PPAP requirements for consumer product APQP and PPAP 2
C How to place software version for SaMD product in HIBC secondary data structure (UDI-PI)? Other US Medical Device Regulations 4
T Does marketing company require CE mark if manufacturer has CE mark on product? EU Medical Device Regulations 5
S Classification of product (measuring or not?) CE Marking (Conformité Européene) / CB Scheme 5
Ron Rompen 4.4.1.2 Product Safety Compliance IATF 16949 - Automotive Quality Systems Standard 29
M Supplier Control for Unique Product ISO 13485:2016 - Medical Device Quality Management Systems 6
R Shelf life of product Other Medical Device Related Standards 4
D One Software as Medical Device product or two? EU Medical Device Regulations 4
J Aerospace Product Key Characteristics AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
F Product classification according to the 60601-2-57: Particular requirements [...] of non-laser light sources [...] IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
M Reworking MDD product w MDR labeling CE Marking (Conformité Européene) / CB Scheme 5
D Regulations covering Sterile product shipments ISO 13485:2016 - Medical Device Quality Management Systems 1
M R&R Studies - how many? per product? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
A Eudamed actor registrations if you change AR for MDR product EU Medical Device Regulations 0
S Reliability issue - Frequent component failure of the product Reliability Analysis - Predictions, Testing and Standards 0
R Statistical Methods for comparing test and reference product equivalence for quality attributes US Food and Drug Administration (FDA) 3
T Do I need to add non-product related service providers to my ASL? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
L How to deal with the model number symbol for X-RAY PRODUCT Other Medical Device Related Standards 1
B Establishment and Product Registration Procedure - UK & EU UK Medical Device Regulations 0
I Is SRN required for a contract manufacturer (CE-Marking product)? EU Medical Device Regulations 2

Similar threads

Top Bottom