1st day success!

M

mibusha

#1
Just want to report that we had our first day of the QS 9000 TE registration audit. So far- no minors and no majors!

Tomorrow may be another story but... . We are using NSF and I am very happy with them.

Till tomorrow... .
 
Elsmar Forum Sponsor
D

Dan De Yarman

#2
Congratulations on your first day of success. Our registration audit is next week, and I really don't think we are going to do that well on one major point - R&M. I just don't believe we have had enough time to get everything together before the audit but, oh well.

Again congratulations.
 
M

mibusha

#3
We passed! After corective action on 6 minors we will be recommended for QS 9000 TE.

It was a more exhaustive audit than at my previous company, a much better "snapshot".

Thanks Tom G for the registrar reference. They were indeed complete and fair and added value to our quality system.

Also thanks to Marc and everyone on this forum. It is an excellent resource from which I was able to get needed information which was simply not available anywhere else.

Now for that wine that was delivered to my company today... .

Michael
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#4
Congratulations and don't forget to stop by often to help others who have questions!
 
R

Rich S.

#5
Congrats on your company's effort and results. I've enjoyed following your posting on the project. I would really appreciate a listing on the nature of the registrar's findings.

Although we are going for iso 9001, We will evolve oput system to satisfying the TE requirements. We interviewed Mr. Carter and NSF and I was favorably impressed (and out voted for a famous mark).
 
M

mibusha

#6
This is a summary of the problems our auditor found, all legitimate but not serious enough to warrant panic.


CAR # Description

R1 Design plan needs to show milestones for design review meetings. 4.4.6


R2 Must show evidence that our vendors have reviewed government regulations and safety concerns.4.6.1.2


R3 Approved vendor list must include outside calibration sources 4.6.2.c


R4 Vendor surveys do not fully address development of the vendor to QS 9000 TE 4.6.2.1


R5 No evidence of procedures for handling and protecting of calibration equipment 4.10.6.3


R6 Records section of procedure does not address how we eventually dispose of the records 4.16.1



Note: All CARs are against QS 9000 TE standards.


I hope to do corrective action, procedure modification and training within a few days.

Michael
 
Thread starter Similar threads Forum Replies Date
T Sample of 1st Article Inspection Report wanted APQP and PPAP 3
K China UDI Implementation for October 1st 2019 China Medical Device Regulations 4
J AS9100D Sections related to 1st Piece and In-Process Inspection Manufacturing and Related Processes 15
V Handling decomissioned line/equipment during 1st time product-based inspection US Food and Drug Administration (FDA) 1
A 1st Time Purchase of Aluminum Extrusion - First Article? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
Q Effective 1st Piece Inspection Sign Off Procedure Quality Manager and Management Related Issues 8
S 1st AHWP-RAPS Joint Conference @ KL, Malaysia 2-3 Dec 2013 Other Medical Device Regulations World-Wide 2
A Publication Dates of MSA Manuals (1st & 2nd Ed.) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
D QMS 1st Cycle - Indicators and Data ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
N 1st Shift vs. 2nd Shift Production Crews - How to end this war? Career and Occupation Discussions 15
W Is there an IEC 60601 3rd Edition 1st Amendment? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
Q Using Traceable Standards - AIAG MSA Manual Chapter II, Section B, 1st bullet Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
M Class I Medical Device - 1st notification and change notification EU Medical Device Regulations 4
K Raw Materials from 3rd World Countries vs. Finished Products from 1st World Countries Philosophy, Gurus, Innovation and Evolution 23
somashekar Medical Device Regulation - Singapore - 1st May 2010 Other Medical Device Regulations World-Wide 4
N What is a ?Reasonable? failure rate for an electronic device in the 1st year? Quality Tools, Improvement and Analysis 7
J FAA Training suggestions wanted for Sept 1st week Federal Aviation Administration (FAA) Standards and Requirements 5
N Nonconforming Product - 1st Piece Rejection Nonconformance and Corrective Action 3
G APQP 1st edition VS APQP 2nd edition - what are the main changes APQP and PPAP 2
CarolX Blueprint numbering for 1st Article submission Misc. Quality Assurance and Business Systems Related Topics 13
C Passed the CQE (Certified Quality Engineer) exam 1st time Professional Certifications and Degrees 23
C 1st Gage R&R Results help Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 48
J Final Inspection - 1st Article Dimensions before Anodize and Passivation Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
P Digital Camera 1st DSLR Coffee Break and Water Cooler Discussions 10
ScottK ISO9001 - 1st Surveillance less than 6 months after registration ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
R AIAG's FMEA Manual 4th Edition pushed back to 1st quarter 2008 FMEA and Control Plans 16
CarolX Definition 1st, 2nd and 3rd Party Audits - Definition Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 29
M Our 1st surveillance audit is coming soon - Any new input..or requirment..? IATF 16949 - Automotive Quality Systems Standard 6
SteelMaiden FDA approves 1st drug for obese dogs World News 6
P 1st Article Part - Recording All Dimensions vs. Critical Dimensions - AS9100B AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 24
B Should 1st Piece Process be a Control or a Line Item in the Control Plan FMEA and Control Plans 10
Marc Ford Has $1.19 Bln 1st-Qtr Loss on Job-Cutting Costs World News 15
J The AIAG's SPC manual 1st Edition and 2nd Edition - Differences? Statistical Analysis Tools, Techniques and SPC 2
Jeff Putman Meeting the 3rd Party Lead Auditor Prior to the 1st Audit IATF 16949 - Automotive Quality Systems Standard 4
Howard Atkins Errata for the AIAG's MSA Third Edition; 1st and 2nd printings Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
D What does 1st piece (1st Article) mean to a lay person like myself? IATF 16949 - Automotive Quality Systems Standard 12
A AIAG's SPC manual 2nd edition vs. 1st edition - Has it changed? Statistical Analysis Tools, Techniques and SPC 6
S Gmail invite - 1st asked - 1st served... After Work and Weekend Discussion Topics 5
C Consequences of Missing the Chrysler July 1st TS 16949 Deadline IATF 16949 - Automotive Quality Systems Standard 31
Sean Kelley Successful 1st Gage R&R Study...but Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 15
G 1st Articles / Initial Sample Submissions - Requirements for submitting PPAPs Other ISO and International Standards and European Regulations 5
D 1st Internal Audit & Training Internal Auditing 8
F Bayes Success run Theorem for sample size during OQ&PQ Qualification and Validation (including 21 CFR Part 11) 4
V When and How to apply the Bayes Success Run approach for Sample Size Determination Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
B Bayes Success-Run on Attribute Data - Determining Sample Size Statistical Analysis Tools, Techniques and SPC 2
A ISO 9001 Registration Audit Success! Covegratulations 2
Q Success or failures using Quality inspection services in China Quality Manager and Management Related Issues 2
C What is the Success Rate in CE Mark Certification for Medical Devices? CE Marking (Conformité Européene) / CB Scheme 12
C What is the success rate for FDA Medical Device Approval ? US Food and Drug Administration (FDA) 5
AnaMariaVR2 Change Anything: The New Science of Personal Success [book] The Reading Room 1
Similar threads


















































Top Bottom