FMEAs, APQPs and Control Plans everytime?

S

sarangk

#1
We are a custom dump truck bodies and trailers producing company, ISO 9001 certified and currently working towards QS. We make new designs for every new order, although designs are somewhat similar to previously used, they are not exactly alike. Do I have to do a new FMEA, APQP and a Control Plan for every new design??

Thanks
Sarang
 
Elsmar Forum Sponsor
T

Tom Goetzinger

#2
There is nothing wrong with using generic FMEA's, Control Plans, etc. if they are appropriate for your business and your processes. These documents should be helpful to your business, not a burden, which I suspect would be the case if you started over each time. This is not to say that once you generate your generic document that it never changes. These are intended to be used and to change (improve) as you continue to use them.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#3
Do them on your processes, not your product, and you will find the burden not so heavy.
 
Thread starter Similar threads Forum Replies Date
B Confusion on the new FMEA guidebook - Are we supposed to replace our FMEAs? IATF 16949 - Automotive Quality Systems Standard 3
A Risk-benefit Analysis - Hazard Analysis (HA) and FMEAs ISO 14971 - Medical Device Risk Management 18
T Document Control of FMEAs and Control Plans FMEA and Control Plans 5
J Efficiently Produce Control Plans and FMEAs FMEA and Control Plans 1
V The best practice to maintain & link Design and Process FMEAs FMEA and Control Plans 8
L Do ISO 13485 Certified Organizations need to have Control Plans and FMEAs? ISO 13485:2016 - Medical Device Quality Management Systems 11
Adriane How Confidential are my FMEAs and Control Plans Quality Manager and Management Related Issues 3
V Examples for failure modes of Design & Process FMEAs FMEA and Control Plans 5
B Risk Management and FMEAs - IEC 60812, SRC-HDBK-1120 and SEQ-J1739 ISO 14971 - Medical Device Risk Management 3
N ISO Certifications and FMEAs FMEA and Control Plans 11
D Customer Complaints and Visual Inspections - Process FMEAs FMEA and Control Plans 2
Q FMEA Scaling - Both D and P FMEAs' in Electronics Manufacturing FMEA and Control Plans 2
Jen Kirley Do you use software and/or database for FMEAs rather than Excel? FMEA and Control Plans 32
A FMEAs using P-diagrams (Parameter Diagrams) FMEA and Control Plans 11
P Fourslide FMEA - Part Specific vs. Family Specific FMEAs FMEA and Control Plans 12
R C&E (Cause and Effects) Diagram for FMEAs for any SC,CC, Hi Impact Cs? FMEA and Control Plans 4
B Linking: Process Flow - 'Common' Process FMEAs - Control Plan FMEA and Control Plans 11
A Commerical off the shelf items (COTS) in DFMEA's (Design FMEAs) FMEA and Control Plans 5
M Linking Process Flow Charts, FMEAS and Control Plans for TS 16949 FMEA and Control Plans 4
A PFMEA for many products - How to reduce the number of FMEAs? FMEA and Control Plans 13
G Detection Rating in Design FMEAs (DFMEA) FMEA and Control Plans 2
C Process Design FMEAs: What are the best practices? Design and Development of Products and Processes 9
H Six Sigma Tools - Alturnate Tools such as FMEAs & Control Charts Six Sigma 9
P Shipping by our own truck as part of an FMEA - Where FMEAs should end FMEA and Control Plans 6
S Recommended Actions in FMEAs FMEA and Control Plans 2
Marc T&E Supplier Process FMEAs QS-9000 - American Automotive Manufacturers Standard 0
L T&E Supplier Process FMEAs FMEA and Control Plans 2
P IATF 16949 requirement - error-proofing in control plan IATF 16949 - Automotive Quality Systems Standard 2
C 8.5.1.1 Control of Equipment, Tools, and Software Programs - Questions about the extent of control of NC programs AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
Q Version/Revision Control of CAD files Document Control Systems, Procedures, Forms and Templates 2
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 7
I Control Plan (Product/Process specification/ Tolerance) acceptance FMEA and Control Plans 27
Sravan Manchikanti How to interpret '8.3 Control of nonconforming product' for SaMD device while implementing ISO 13485 & MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 4
Z Putting back excluded rows/data points in a control chart Using Minitab Software 0
J Control Plan use on the manufacturing floor FMEA and Control Plans 4
E Change in control plan - Do I have to do sampling? IATF 16949 - Automotive Quality Systems Standard 1
D All Dimensions listed on control plan FMEA and Control Plans 10
W Need for current design or process control FMEA and Control Plans 2
Q ISO 9001 8.5.1 - Control of production and service performance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
A What is the difference between Design Process, Process Design and Design Control? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A Beginners help with ISO3951-2 Combined control s-method n>5 what is Phi ?? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
C Corrective action for failure in documents control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
B Control chart and sample time Statistical Analysis Tools, Techniques and SPC 1
DuncanGibbons Manufacturing Plan vs Material Specification vs Control Plan Manufacturing and Related Processes 4
J Control chart for huge sample size Statistical Analysis Tools, Techniques and SPC 9
K Contamination Control - Class Is medical devices (Clause 6.4.2 ISO 13485:2016 (E)) ISO 13485:2016 - Medical Device Quality Management Systems 12
J 510(k) for a control kit for an external IVD test kit 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
T Assessing Hazard-Related Use Scenarios where control measures exist through standards IEC 62366 - Medical Device Usability Engineering 32
adir88 Documenting Risk Control Option Analysis ISO 14971 - Medical Device Risk Management 8
T Design Control Procedures later in the Development Process ISO 13485:2016 - Medical Device Quality Management Systems 6

Similar threads

Top Bottom