SBS - The Best Value in QMS software

DESIGN RESPONSIBLE?

B

BMID

#1
#1
I work at a tool and die shop. We make metal progressive stamping dies and run some production. My question(s)- are tool shops that are going after QS-9000 TE design responsible? We do not design car parts. We do layout our own tool designs but trying to apply APQP and design FMEA just doesn't seem to fit our type of business. Our consultant for QS is telling us we have to follow the APQP manual completely. While I am finding some of it to be useful other parts only apply to cars and not dies. Is our consultant right?
please help
Thanks,
Bob Middleton
 
Elsmar Forum Sponsor
A

Al Dyer

#2
#2
Bob,

A supplier must follow QS-9000 Section 4.4 (Design Control) only if they have the authority to establish a new, or change an existing product specification.

I understand this to mean that if you have the authority to initiate or change customer design records (ie blueprints and specifications)you must follow section 4.4.
See page 23 of the QS-9000 3rd Edition also.

As always, call your customer for a ruling.

------------------
Al Dyer
Mngt. Rep.
JAE Tech Inc.
[email protected]
 
L

Laura M

#3
#3
I'm not sure exactly what your consultant is advising you to do, but my understanding is you have to treat your design (the tool) and establish a process to ensure the design meets the intent. Yes, if you design the tool, 4.4 applies. APQP can be applicable to some extent. Unique designs (also called one-offs) may have less applicability than, say someone producing cutting tools or even, for example, larger equipment such as screw machines, where you can have the same checks being made on each production run. Your FMEA can look at previous builds of similar product and "things that didn't go right" for ways to improve lead time, etc.

So if you consider things like how you conduct design reviews of your tools, how do you verify incoming material, how do you verify your assembly (could be the same PCP for many tools) and what is your final inspection, you can apply some of the techniques of APQP. If you look at the intro to T/E, "implementation" section, it does say that "it is recognized that not all of these requirements are applicable to every organization" - (then uses the obvious example of Element 4.4). However, if you determine something is not applicable, be prepared to justify why. Make sure you think of all angles, because your auditor will.
 
J

Jim Evans

#4
#4
Bob,

Laura hit all the relavent points pretty well. I would add that the TE manual only requires some sort of advanced quality planning it does not say that the APQP model is the one that you are required to use.

Regards,

Jim
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
K Does company who manufacture but does not design or carry out clinical trials is responsible for CE marking for single use medical devices? ISO 13485:2016 - Medical Device Quality Management Systems 3
C Advice on becoming a AS9100 Auditor - Need to audit organizations that are Design Responsible AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
J Not Design Responsible - Can we exclude all or parts of AS9100 clause 8.3 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
M Design & Development - Only 1 Engineer - Who is responsible for Approval? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Q Definition Design Responsible - Good Definition in the context of AS 9100 Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
A Design History File Maintenance - Who is responsible for the Design History File 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
C Configuration Management requirements if this facility is not design responsible AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
A Is a Distributor responsible for Design History Files 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
J Scope of Registration ? Design Responsible ? Outsource Design??? IATF 16949 - Automotive Quality Systems Standard 2
M IMDS Submissions for multiple parts requested, but not Design Responsible IATF 16949 - Automotive Quality Systems Standard 13
C Design Responsible - Determining if Organization is Design Responsible Design and Development of Products and Processes 15
M Design Improvement, but not OEM or Design Responsible Design and Development of Products and Processes 6
D Quality Plan - Necessary for any Order? Mature Processes & Not Design Responsible Design and Development of Products and Processes 6
Z Suppliers: "Design Responsible", "Manufacturing" and "Service Suppliers" Design and Development of Products and Processes 5
T Design responsible? Tier 2 / 3 manufacturer of steel products - TS 16949 Design and Development of Products and Processes 6
S Seeking Internal Audit Plan - Design Responsible Manufacturing company Design and Development of Products and Processes 3
J More Design Questions - Parent Company Design Responsible Design and Development of Products and Processes 6
B TS 16949 for R&D Design Centre - What part are we responsible for? Design and Development of Products and Processes 3
T Not responsible for product design - Exactly which parts of 7.3 do not apply? Design and Development of Products and Processes 3
B My company makes product to order - Are we design responsible? Exclude 7.3? Design and Development of Products and Processes 17
R Design Responsible Design and Development of Products and Processes 2
M Design Responsible? Design and Development of Products and Processes 5
S Examples of FDA acceptable Software Design Specification (SDS) Medical Device and FDA Regulations and Standards News 6
A Design Change/ECO Related Question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
R Using R package to implement Bayesian phase I/II dose-finding design for three outcomes ISO 13485:2016 - Medical Device Quality Management Systems 6
C ISO 9001:2015 8.3.2. h) Design and Development Planning - What is required? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Z Software for design control ISO 13485:2016 - Medical Device Quality Management Systems 3
E Design and Development file Procedure ISO 13485:2016 - Medical Device Quality Management Systems 0
DuncanGibbons Section 8.3 relevant for design organisations AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
P DFMEA - Machinery Design Best Practices FMEA and Control Plans 0
R Is a FAIR required on parts that we design? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
U API Spec Q1 - 5.6.1.2 C (3) - Design software Oil and Gas Industry Standards and Regulations 3
N Example for design and development planning,input,output,review,verification,validation and transfer Misc. Quality Assurance and Business Systems Related Topics 4
A 8.6 Release of products and services, 8.3 Design and development - evidence required ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
C Stress / Challenge Conditions for Design Verification Testing to Reduce Sample Size 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
J Significant change related to design and intended use EU Medical Device Regulations 3
S Traceability of requirements to design and risk Design and Development of Products and Processes 3
U NOC - What is considered a "design change" EU Medical Device Regulations 5
Q PPT used as Design Review ISO 13485:2016 - Medical Device Quality Management Systems 3
D Design Verification Sample Size vs Repeats Statistical Analysis Tools, Techniques and SPC 9
A Design and development procedure for API Spec Q2 Oil and Gas Industry Standards and Regulations 6
D Design controls - Inputs, outputs, V&V, DHF, DMR ISO 13485:2016 - Medical Device Quality Management Systems 10
LostLouie Manufacturer divorced from Design process, is he justified in design process deficiencies? ISO 13485:2016 - Medical Device Quality Management Systems 9
R DFA & DFM - Examples for Design for assembly and design for manufacturability Lean in Manufacturing and Service Industries 2
D Using Laboratory Notebooks in R&D and Design and Development ISO 13485:2016 - Medical Device Quality Management Systems 3
D ISO 13485 - 7.3.6 Design and development verification - Do most folks create a separate SOP? ISO 13485:2016 - Medical Device Quality Management Systems 6
K Joint approval between OEM and Manufacturer on Design Documents ISO 13485:2016 - Medical Device Quality Management Systems 4
M API 4F/7K/8C Design Package Validation Oil and Gas Industry Standards and Regulations 2
A Design History File - Not ready to share the design drawings or Bill of Material US Food and Drug Administration (FDA) 2
W Need for current design or process control FMEA and Control Plans 2

Similar threads

Top Bottom