Supplier Retained Records Requirements - AS9100 4.2.4 Control of Records

S

savvylady

#1
The AS9100C standard says "the documented procedure shall define the method for controlling records that are created by and/or retained by suppliers.

We have sent our suppliers our Terms and Conditions which include a record retention and for how long. Can we contol this by sending the supplier a survey with a question regarding their compliance to our record retention request? If an officer of the company signs the form with a yes, is this a sufficient answer for a Registrar audit?

Thanks.....:cool:
 
Elsmar Forum Sponsor

kgott

Quite Involved in Discussions
#2
The AS9100C standard says "the documented procedure shall define the method for controlling records that are created by and/or retained by suppliers.

We have sent our suppliers our Terms and Conditions which include a record retention and for how long. Can we contol this by sending the supplier a survey with a question regarding their compliance to our record retention request? If an officer of the company signs the form with a yes, is this a sufficient answer for a Registrar audit?

Thanks.....:cool:
savvylady, It may but then it may not depending on the registrar auditor but lets forget the registrar auditor for a while and consider the needs of your own organisation. If its important for your organisation that your supplier retains certain records, as it would be to comply with the standard, then you should go and audit them to check for your self.

If for whatever reason you can't visit your suppliers premises then get them to send you some documentation that shows the required records are being maintained. Pick some documents as examples and ask to see the evidence that they are maintaining them. Use documents which have consecutive numbers if you use them. - k
 

Mikishots

Trusted Information Resource
#3
savvylady, It may but then it may not depending on the registrar auditor but lets forget the registrar auditor for a while and consider the needs of your own organisation. If its important for your organisation that your supplier retains certain records, as it would be to comply with the standard, then you should go and audit them to check for your self.

If for whatever reason you can't visit your suppliers premises then get them to send you some documentation that shows the required records are being maintained. Pick some documents as examples and ask to see the evidence that they are maintaining them. Use documents which have consecutive numbers if you use them. - k
A good method. I like it.
 
S

silentrunning

#4
savvylady, It may but then it may not depending on the registrar auditor but lets forget the registrar auditor for a while and consider the needs of your own organisation. If its important for your organisation that your supplier retains certain records, as it would be to comply with the standard, then you should go and audit them to check for your self.

If for whatever reason you can't visit your suppliers premises then get them to send you some documentation that shows the required records are being maintained. Pick some documents as examples and ask to see the evidence that they are maintaining them. Use documents which have consecutive numbers if you use them. - k
Great advice. Remember - "Trust nobody!"
 
S

savvylady

#5
savvylady, It may but then it may not depending on the registrar auditor but lets forget the registrar auditor for a while and consider the needs of your own organisation. If its important for your organisation that your supplier retains certain records, as it would be to comply with the standard, then you should go and audit them to check for your self.

If for whatever reason you can't visit your suppliers premises then get them to send you some documentation that shows the required records are being maintained. Pick some documents as examples and ask to see the evidence that they are maintaining them. Use documents which have consecutive numbers if you use them. - k
Good advice!

Thanks
 
J

Jeff Frost

#6
The AS9100C standard says "the documented procedure shall define the method for controlling records that are created by and/or retained by suppliers.

We have sent our suppliers our Terms and Conditions which include a record retention and for how long. Can we contol this by sending the supplier a survey with a question regarding their compliance to our record retention request? If an officer of the company signs the form with a yes, is this a sufficient answer for a Registrar audit?

Thanks.....:cool:
Contract requirements such as record retention must be spelled out in the body of the purchase order or through Supplier Quality Assurance Requirement document code letter/number. Most organization do not understand that contract law usually finds that terms and conditions of purchase are superseded by terms and conditions of sale.
 
I

isotexas

#7
Jeff,

You said "Most organization do not understand that contract law usually finds that terms and conditions of purchase are superseded by terms and conditions of sale."

I am one of those organizations... so what your saying is, as a customer purchasing from a supplier, their T&Cs trump mine in court? What if theirs say the keep records for a different period of time? Say 1 year and not 2 years as I requested in my T&Cs? Aren't they, upon accepting my PO, saying they will comply?

Soooooo confused
 
Thread starter Similar threads Forum Replies Date
J Minimum Supplier Certifications for Food Supplements Food Safety - ISO 22000, HACCP (21 CFR 120) 1
R Supplier/Vendor Surveys (360) Supplier Quality Assurance and other Supplier Issues 1
was named killer AS9100 Supplier Approval Requirements AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 10
B AS9100 8.4.1 Supplier Selection/Evaluation criteria and reevaluations AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 13
J Sub-supplier change from manual to automated process - same specs - Report to FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
M Supplier Audit Report - Template for second party audit wanted Lean in Manufacturing and Service Industries 1
T Difference between a subcontractor and a supplier ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
Ed Panek Corona Virus impact on Supplier Audits and Received Parts ISO 13485:2016 - Medical Device Quality Management Systems 4
NDesouza Verification of Supplier RCCAs Nonconformance and Corrective Action 5
K Supply Agreement Regarding MDR 2017/745 - Manufacturer-supplier cooperation Other Medical Device Related Standards 0
L How to deal with an ISO 13485 Supplier Audit nonconformance ISO 13485:2016 - Medical Device Quality Management Systems 17
P Supplier Audits in the wake of COVID-19 ISO 14971 - Medical Device Risk Management 2
T Ideas for developing a Supplier Quality Management System, non automotive ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
B Vendor (Supplier) Evaluations and Reports Supplier Quality Assurance and other Supplier Issues 11
F Is there such a thing as 'Critical supplier' status under the Dept. of Health (UK)? Medical Device and FDA Regulations and Standards News 2
A MSA results differences - Supplier results vs. My results Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
G Supplier flowdown verification of tests and revisions Supplier Quality Assurance and other Supplier Issues 0
B Supplier of design and manufacture process ISO 13485:2016 - Medical Device Quality Management Systems 10
S Software for Supplier Charge back and internal PPM General Information Resources 2
R IATF/IAOB Red Supplier Pilot Program IATF 16949 - Automotive Quality Systems Standard 1
M Changing supplier of critical raw material (III class device) Other Medical Device and Orthopedic Related Topics 1
S VW Supplier Product Safety Representative (PSB) upgrade to PSCR VDA Standards - Germany's Automotive Standards 0
S Process Map for Supplier Process Maps, Process Mapping and Turtle Diagrams 5
D Licensee as a Supplier on the ASL Medical Device and FDA Regulations and Standards News 10
R Definition Key Supplier - Definition of Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 7
V IATF 16949 8.4.1 Control of externally provided processes, products and services - Should the CB be on our Approved Supplier List? IATF 16949 - Automotive Quality Systems Standard 10
M Risk Classification For Supplier - Clinical Research Organisation (CRO) Supply Chain Security Management Systems 3
shimonv Rigid rules for handling supplier audit findings ISO 13485:2016 - Medical Device Quality Management Systems 11
G Supplier Checking With Gauge Pin Problem Solving, Root Cause Fault and Failure Analysis 2
R AS9100 DELTA FAI - Sub-supplier for plating changed AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
P IATF 16949 8.4.2.4 Supplier Monitoring IATF 16949 - Automotive Quality Systems Standard 2
A Supplier Quality Standard vs Senior Management Direction Supplier Quality Assurance and other Supplier Issues 2
E Part 11 Compliance, Excel living documents (i.e. document master list, equipment list, approved supplier list) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
R Supplier evaluation and business needs in the context of ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 2
J IATF 16949 8.4.1.2 Supplier selection process IATF 16949 - Automotive Quality Systems Standard 4
Q Supplier audit question cataloque VDA Standards - Germany's Automotive Standards 0
Ed Panek Inactive key supplier question - We are not actively buying from them ISO 13485:2016 - Medical Device Quality Management Systems 2
Ajit Basrur Quality Agreement with supplier covering medical devices and consumer requirements ISO 13485:2016 - Medical Device Quality Management Systems 2
K Supplier re-evaluation (API Q1) Manufacturing and Related Processes 8
C Approving AWS as a supplier (ISO 13485) ISO 13485:2016 - Medical Device Quality Management Systems 1
R Supplier related drawings and verification of process requirements - Source Inspection AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
Q AS9120 Vendor of ESD Monitoring Equipment needs to be in the Approved Supplier List? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 8
R Supplier Controls we can place on Single-Source Suppliers ISO 13485:2016 - Medical Device Quality Management Systems 2
N Declaration of Conformity for Product from Supplier ISO 13485:2016 - Medical Device Quality Management Systems 6
M Supplier selection criteria - Medical devices ISO 13485:2016 - Medical Device Quality Management Systems 3
Ed Panek Can a single supplier fit two or more categories for risk? ISO 13485:2016 - Medical Device Quality Management Systems 2
V Determining FDA 820 (registration) vs ISO 13485 - Supplier gives us the kit ISO 13485:2016 - Medical Device Quality Management Systems 1
G ISO 22442 Supplier Audit Checklist - Medical devices utilizing animal tissues General Auditing Discussions 0
Jen Kirley Moving on - I accepted an offer to be a Supplier Quality Engineer at GE Healthcare Coffee Break and Water Cooler Discussions 42
K Supplier Controls for Animal Tissue Suppliers for Medical Devices Other Medical Device Regulations World-Wide 0
Similar threads


















































Top Bottom