SBS - The Best Value in QMS software

Does AS9100 require traceability to operators performing the work?

Elsmar Forum Sponsor

mattador78

Quite Involved in Discussions
#2
Does AS9100 require traceability to operators performing the work such as stamps or sign off?
Hi all of our AS9100D production is traceable back to an operator through stamps and signatures to show completion of the required processes. 8.5.2 onwards will help you to determine your requirements for process identification then it is your determination of "signing off". Each operation here requires a stamped finish with each stamp traceable to an individual operator, with the CofC signed by the final inspector acknowledging all the processes are accounted for and complete.
 

John Predmore

Trusted Information Resource
#3
AS9100 section 8.6.b does require traceability to "the person(s) authorizing release" of product. Section 8.5.2 states "The organization shall implement planned arrangements, at appropriate stages, to verify that the product and service requirements have been met.... When acceptance authority media are used (e.g., stamps, electronic signatures, passwords), the organization shall establish controls for the media. " If individual operators are verifying their own work, what @mattador78 said would be a good practice.
 

mattador78

Quite Involved in Discussions
#4
We also store a digital copy of all stamped paperwork and a signed copy of the CofC as a traceable record, admin wise that was a bit of a ball ache to begin with. However, it is brilliant to be able to show that next to our ERP information during an audit. All staff have also signed to acknowledge that the stamps are company property and misuse or willful damage can result in a disciplinary procedure, in 12 months of using them there has been no loss damage or misuse by anyone (except for me who in the first week dropped his and ran it over with a forklift :oops:)
 

Cari Spears

Super Moderator
Staff member
Super Moderator
#5
8.6.b requires traceability to the person(s) authorizing the release of product.
8.7.2.d requires documented information that identifies the authority deciding the action in respect of the nonconformity.
How you document traceability is up to the organization.

There is not an AS9100 requirement for traceability of all operators performing work. The use of stamps or initials for traceability to any other persons performing work would be the organization's choice, or a customer requirement.

We have inspection stamps issued to all inspectors, and the person dispositioning nonconforming product has to sign off. We also maintain traceability of weld personnel performing work due to our requirements for continuity to maintain their welder qualifications - this is not an AS9100 requirement, it is a customer requirement.
 
Thread starter Similar threads Forum Replies Date
A Does AS9100 require Suppliers to be Certified to ISO or AS? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
R Does AS9100 require that QA review all POs before release AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
G Does AS9100 require approving your Customer as a Supplier? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
B Does each shot peening timer require calibration - AS9100 requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
S Mandatory Procedures - Does AS9100 REV B require mandatory procedures? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
T What does AS9100 mean when it says you must establish a process to do X? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 24
C Does anyone have an AS9100:2015 audit schedule template? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
D Does AS9100 certified OEM need AS9110 if no maintenance is provided? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
G Does AS9100 Certificate include ISO 9001 Certification? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
C How long does AS9100 QMS need to be in place before the Audit? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 13
S Does anyone have an AS9100 System Training Datum? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
V AS9100 and AS9102 - Does our supplier have to do the FAI using the 3 AS9102 forms? Document Control Systems, Procedures, Forms and Templates 3
M AS9100 First Article - Does 7.5.1.1 revC or 8.2.4.2 revB apply to Non Aerospace Goods AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 19
A AS9100 7.4.2 d) - What does Revision Status mean? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 20
S Does all work in a shop need to meet AS9100 standards in order to be certified? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
A How does your registrar handle 2 certificates, one for AS9100 and one for ISO9001? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 18
E What is a Proprietary Procedure and how does it apply to AS9100? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
K What does an AS9100 RABQSA auditor get paid? Career and Occupation Discussions 12
D Does AS9100 have "special" retention times for any items? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 21
S Does anyone have a checklist to prepare for ISO 13485, Stage I audit? ISO 13485:2016 - Medical Device Quality Management Systems 1
S Does a refurbished product required a new UDI? US Food and Drug Administration (FDA) 0
D Change to labelling - does it require a new 510(k)? US Food and Drug Administration (FDA) 5
M What does "constantly" mean ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
N Does anyone use SGS for ISO 13485 / CE certification Registrars and Notified Bodies 0
G Does FDA allows remote approvals of quality documentation. Is there any specific guidance on signing any quality records remotely? Document Control Systems, Procedures, Forms and Templates 1
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 1
lanley liao Does all of the suppliers need to integrated into the supplier list qualified of the company? Oil and Gas Industry Standards and Regulations 2
0 To which part of 13485 does this refer? ISO 13485:2016 - Medical Device Quality Management Systems 3
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
J Records Control - Does each individual record need to be numbered? Records and Data - Quality, Legal and Other Evidence 2
lanley liao Does the customer`s trademark belong to customer-supplied property? Oil and Gas Industry Standards and Regulations 2
H How does a gas turbine work on diesel fuel? Oil and Gas Industry Standards and Regulations 12
G What does performance specification include? US Food and Drug Administration (FDA) 1
W Where does a coatings and paint company fall in IATF? IATF 16949 - Automotive Quality Systems Standard 5
A How much does a complete biocompatibility test package cost? Other ISO and International Standards and European Regulations 1
B Does anybody know how to get older versions of Minitab to work in Windows 10? Quality Tools, Improvement and Analysis 9
M Does the ISO 9001:2015 standard require a disaster recovery plan or emergency response plan ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
C Does an accessory need an IFU if it use is discussed in the Parent device IFU? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
S How long does it take to register a product with MHRA? UK Medical Device Regulations 8
M Quality Manual - Where does Revision History Section go? Document Control Systems, Procedures, Forms and Templates 8
U Does *anyone* know a lab that will test to EN 455-4 Medical Gloves shelf life determination? EU Medical Device Regulations 1
A Brexit When does the UK responsible person need to be in place? UK Medical Device Regulations 10
M How does IEC-60601-1 apply to a non-medical device in the patient vicinity? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
N Does anyone have experience of GB/T 34986-2017? China Medical Device Regulations 1
Z Does anyone have experience with EN ISO 17664 ? IEC 62366 - Medical Device Usability Engineering 9
F Does anyone have an ESD quality/cooler talk to share? Training - Internal, External, Online and Distance Learning 4
A What does this line from MDCG 2020-3 (MDR art. 120 substantial change) mean to you? EU Medical Device Regulations 4
D Change Approval Requirements - Does every change need formal customer approval? Design and Development of Products and Processes 17
L Does a backdate form format can be changed if wrong revision is used? Document Control Systems, Procedures, Forms and Templates 8
B General Motors and Honda Alliance - What does this mean to suppliers? IATF 16949 - Automotive Quality Systems Standard 3

Similar threads

Top Bottom