QSR 3rd Edition, section II Run at Rate ([email protected]) - What do they want?

R

Richard Fillbach

#1
What exactly is Ford Motor Company looking for in the QSR 3rd Edition, section II concerning [email protected] and is there some type of formula or form you use. I know it concerns quote capacity but since we are a tier 2 supplier, we have never had to conduct [email protected] test. Our customer is now requiring it from us so I am asking any information on what [email protected] is and how do you go about completing the requirement.
Thank you
 
Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration
Staff member
Admin
#2
If none of the local experts answers this in a day or two I'll take a shot at it. It's been a while since I have heard those wonderful words!
 
B

Batman

#3
I can give a little info based on our [email protected] rate from GM. The STE takes the control plan and flow diagram from the PPAP, the quote we supplied regarding parts per hour/week/month, and they watch the process run. They count parts for a few hours, and determine if the quote was accurate, and the flow is the same, and the control plan is being followed. Scrap, operator breaks, etc. are taken into consideration. During the few hours the STE actually roams about, checking any related operational stuff, such as bill of materials, FMEA, any supplier issues if purchased components are involved, etc. It is usually a one shift visit, and you pass or fail. If there are any issues, either corrective actions or improvement opportunities are agreed to with due dates.
 

Howard Atkins

Forum Administrator
Staff member
Admin
#4
We also as tier 2 have had [email protected] by the tier 1. As batman said the PPAP is checked against what is in place etc. The amount of production counted etc. In general the process is the more important factor than the actual production time.
According to the strict application of the rules you can only do a [email protected] when the part has been approved as otherwise you are producing parts which could be not accepted. This can be used as a lever for approval.
It is also possible to do a self run [email protected], the GM procedure is in GM1960 (GP9).
If your PPAP is correct and you work as you say the process is painless.
 
Thread starter Similar threads Forum Replies Date
E All shifts at surveillance audit? Appendix H, point 5, page 109 QSR 3rd Edition QS-9000 - American Automotive Manufacturers Standard 5
T Gage / Measurement Uncertainty - QS-9000 QSR 3rd Edition 4.11.1 Measurement Uncertainty (MU) 6
M Informational From Medtech Insight – QSR/ISO 13485 Harmonization Update: FDA Enforcement Discretion Likely When New Rule Stands Up; Draft Reg Coming By Year’s End; Medical Device and FDA Regulations and Standards News 0
Marc Problem with 21 CFR Part 820 - US FDA Quality System Regulations (QSR) sub-forum link - 2 May 2019 Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 1
D FDA QSR task checklist based on inspection citations 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
B Classes/ Online Training on ISO 13485:2016 and FDA QSR Part 820 ISO 13485:2016 - Medical Device Quality Management Systems 5
S Supplier Evaluation - Is a supplier score card a requirement under ISO and QSR? ISO 13485:2016 - Medical Device Quality Management Systems 7
V QMS / QSR - Reference to Framework - Templates - Procedures for Medical Devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
Y ISO 13485:2003 &FDA QSR (21 CFR 820) Quality Manual,34 Procedures and Form Book, Video, Blog and Web Site Reviews and Recommendations 8
A How to obtain Preamble to Quality System Regulation (QSR) ? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
P FDA QSR Inspection Consultant Recommendations 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
shimonv Classification of Complaints from Beta Sites - Complaints Definition per QSR 820.3 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M QSR - Design Control on Existing Device not Designed following QSR 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
H USFDA -QSR Audit Check List 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
I Recording of In Process Data to Meet FDA QSR 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
T Can I approve my own Documentation per FDA QSR 21 CFR Part 820? ISO 13485:2016 - Medical Device Quality Management Systems 1
A How many processes for an FDA Quality System (QSR)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
P What's the difference between ISO13485 and FDA/QSR? ISO 13485:2016 - Medical Device Quality Management Systems 16
D Off-the-shelf SW S.O.P. for non-product QSR regulated and non-regulated applications IT (Information Technology) Service Management 6
S OEM Supplier of Accessories Registration and 21 CFR 820 QSR Controls Applicability 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
G Understanding Identification of Design in QSR 21 CRF Part 820.30 Design Control (f) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A Does any one have FDA 21 CFR Part 820 QSR training material? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
Q How Demings Point 9 (of his 14 points) is related to the FDA QSR Quality Tools, Improvement and Analysis 3
M ISO 13485 and FDA QSR Employee Training Requirements when Procedures are Revised Manufacturing and Related Processes 5
G Legacy Product - Do we need follow QSR 820? Design Verification and Validation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 12
B FDA QSR Data Analysis & Trending Requirements US Food and Drug Administration (FDA) 5
W Injection Molding Validation Required or Not - FDA QSR 820.75 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
A Purchasing Information Requirements - ISO 13485 Clause 7.4.2 and FDA QSR Supplier Quality Assurance and other Supplier Issues 2
A QSR (820.30 part e) Design Review and Design Control Responsibilities 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
W Auditing to multiple standards & requirements - CMDR, MDD, ISO13485, QSR. General Auditing Discussions 3
Q ISO 13485, FDA's QSR, CMDR, MDD: Seeking Internal Audit Correlation Matrix Various Other Specifications, Standards, and related Requirements 3
S FDA 21 CFR 820 QSR Quality Manual example wanted 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M FDA QSR Requirements - Checklist for Class II Medical Device Contract Manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
W What is "Design Input" by QSR, 21 CFR Part 820 ? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
D How to Measure QSR Training Effectiveness? Training - Internal, External, Online and Distance Learning 6
C Definition Design Transfer - New requirement of QSR 820 - What is Design Transfer? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
M Practical Reasons Behind The ISO 13485/QSR Regulations ISO 13485:2016 - Medical Device Quality Management Systems 6
C QSR 820.120 labeling and packaging control 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
C Questions about the "change control procedure" in FDA's QSR manual 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M CLIA vs. QSR Audit Differences - and - Audit templates for CLIA audits ISO 13485:2016 - Medical Device Quality Management Systems 3
D Definition Q - Definitions of all the Q's - QM, QMS, QP, QSR, etc. Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 18
T What would the FDA expect to see when they ask for our QSR? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 20
D Administrative personnel training - ISO 13485 and FDA QSR requirements ISO 13485:2016 - Medical Device Quality Management Systems 4
W FDA QSR Inconsistency? Design Validation Design and Development of Products and Processes 17
GStough FDA QSR (Quality System Regulation) Training Needed in the Southeastern USA Training - Internal, External, Online and Distance Learning 7
D Presentation on Subject: Potatoes (QSR interested in the potato market) Misc. Quality Assurance and Business Systems Related Topics 17
H Sample Design Plan that complies with FDA QSR, ISO 13485 & 14971. ISO 14971 - Medical Device Risk Management 5
Alex.Jo Re-manufactured vs. Refurbished under FDA QSR ISO 13485:2016 - Medical Device Quality Management Systems 2
K QSR Sections for a Medical Device - Seven questions ISO 13485:2016 - Medical Device Quality Management Systems 9
C Software recommendations for CAPA that will meet the FDA QSR & Part 11 Quality Assurance and Compliance Software Tools and Solutions 4
Similar threads


















































Top Bottom