Referencing to Supplier Outputs within our Document Control System

#1
Hello,

First time posting, I hope this is the correct group. Please let me know if it is not.

The company I current work for develops combination products which we package in standard cardboard cartons (non-sterile barrier). For much of our packaging development we rely on a third party who we work with to create the outputs (Drawings and specifications) based on our input requirements. We review and approve those outputs and then they get controlled in the vendors validated document control system. In our DHF we then point to the document at our vendor and we have quality agreements in place on access to those files during an audit.

As they manufacture against their approved output and changes to those outputs would require reapproval from us is there any need to re-control or duplicate the control of this output within our document control system? I’m always cautious about duplication of documentation.

Any standards or regulations you could reference to support your position would be greatly appreciated. Most of what I have found to date is very high level.
 
Elsmar Forum Sponsor

somashekar

Staff member
Super Moderator
#2
Hello,

First time posting, I hope this is the correct group. Please let me know if it is not.

The company I current work for develops combination products which we package in standard cardboard cartons (non-sterile barrier). For much of our packaging development we rely on a third party who we work with to create the outputs (Drawings and specifications) based on our input requirements. We review and approve those outputs and then they get controlled in the vendors validated document control system. In our DHF we then point to the document at our vendor and we have quality agreements in place on access to those files during an audit.

As they manufacture against their approved output and changes to those outputs would require reapproval from us is there any need to re-control or duplicate the control of this output within our document control system? I’m always cautious about duplication of documentation.

Any standards or regulations you could reference to support your position would be greatly appreciated. Most of what I have found to date is very high level.
You are perfectly fine as long as you have the required competency to demonstrate for your approving status. The rest of it depends upon your controls you exercise initially and periodically on the process that is outsourced.
.
..
...
And welcome to the COVE
 
Thread starter Similar threads Forum Replies Date
M Referencing Harmonised Standards in Declarations of Conformity EU Medical Device Regulations 4
M Referencing the MDR by name in QMS SOPs EU Medical Device Regulations 2
J Referencing Medical Device in FDA records - Package contains several other components Other Medical Device Regulations World-Wide 1
M Informational EC – Guide for referencing standards in public procurement in Europe (JIS Action 11) Medical Device and FDA Regulations and Standards News 0
N Referencing of a standard's year in routine regulatory compliance documents Other Medical Device Related Standards 3
M Referencing ISO 9001:2015 clause for Audit General Auditing Discussions 10
S Referencing International Standards as Design Input Design and Development of Products and Processes 5
D Referencing Standards in Procedures - Current version or actual? Document Control Systems, Procedures, Forms and Templates 6
S Referencing procedures on Control Plans - Best Practices FMEA and Control Plans 3
P Question on First Article Inspection referencing ISO 2768 APQP and PPAP 1
J Referencing the DMR (Design Master Record) in the PO Document Control Systems, Procedures, Forms and Templates 2
Q Referencing EN 63204:2006 instead of EN 62304:2006 AC:2008 IEC 62304 - Medical Device Software Life Cycle Processes 9
Q Referencing a Specification in a Work Instruction as a ?Guidance Document? ISO 13485:2016 - Medical Device Quality Management Systems 1
Crusader 7.6 Calibration (referencing outsourcing) in the Quality Manual Quality Management System (QMS) Manuals 5
M Referencing Standards in Engineering and Regulatory Documents Other ISO and International Standards and European Regulations 1
R Para 4.2.2 b) Referenced Documents - Adequate referencing? Copy and Paste? ISO 13485:2016 - Medical Device Quality Management Systems 5
S Referencing other documents in Control Plans Quality Manager and Management Related Issues 5
P Referencing of Forms in Procedures ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M Referencing the Regulation in a Design Specification 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
C Referencing or Using a Master Part to take Measurements Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
R Referencing and Controlling Labels & Stickers used internally throughout Production Document Control Systems, Procedures, Forms and Templates 1
Q AS9100 and NADCAP - Our QM was told that referencing IPC 620 was acceptable AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
SteveK Referencing somebody else?s CE Mark and NB Number on an Instruction Leaflet? CE Marking (Conformité Européene) / CB Scheme 7
N Cross-Referencing ISO 9001/ISO 14001/OHSAS 18001 Occupational Health & Safety Management Standards 17
kmyers Question about referencing software - Database Records Document Control Systems, Procedures, Forms and Templates 11
L Surveillance Audit - NC for not referencing requirement of Cl 6.4 in audit plan ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
Q Work instructions - Referencing other documents including procedures Document Control Systems, Procedures, Forms and Templates 18
A Calling / Referencing National Standards in Quality Manuals Quality Management System (QMS) Manuals 1
G Dealing with non conformity caused by Supplier Components detected in the production line IATF 16949 - Automotive Quality Systems Standard 8
G Supplier doesn't accept the complaints Supplier Quality Assurance and other Supplier Issues 19
K New supplier audit as per V3.1 by French Automotive OEM General Auditing Discussions 2
A ASL requirement when the supplier is certified for ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
S Supplier Management ISO 13485: 2016- Which supplier needs to fill in a self assessment form? ISO 13485:2016 - Medical Device Quality Management Systems 6
D Approved supplier list for R&D ISO 13485:2016 - Medical Device Quality Management Systems 5
M SemaTech SSQA Standardized Supplier Quality Assessment - my favorite tool ever Manufacturing and Related Processes 1
D Supplier Quality level category help - high level ISO 13485:2016 - Medical Device Quality Management Systems 6
J Supplier Controlled Shipping (GM CS1) Condition Manufacturing and Related Processes 3
L Supplier within the Organization ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
D Supplier Quality - How to classify a supplier level Medical Device and FDA Regulations and Standards News 7
P Understanding DFMEA and PFMEA - Supplier Related IATF 16949 - Automotive Quality Systems Standard 21
S Can assembly manufacturing sub-supplier be certified IATF 16949? IATF 16949 - Automotive Quality Systems Standard 6
M How Supplier Capacity check is done by competitors Manufacturing and Related Processes 0
C One Time Service Supplier - Temperature and Humidity Testing Service ISO 13485:2016 - Medical Device Quality Management Systems 5
M Supplier Audits - Stop Wasting Everyone's Time! General Auditing Discussions 15
G Supplier management when the supplier is your headquarter IATF 16949 - Automotive Quality Systems Standard 3
V Supplier wants to perform pre-qualifications prior to every run instead of locking in parameters. Supplier Quality Assurance and other Supplier Issues 7
D Class 3 Device - Change of supplier of material Canada Medical Device Regulations 6
D List A IVD - Change to material supplier EU Medical Device Regulations 3
J Minimum Supplier Certifications for Food Supplements Food Safety - ISO 22000, HACCP (21 CFR 120) 3
R Supplier/Vendor Surveys (360) Supplier Quality Assurance and other Supplier Issues 1

Similar threads

Top Bottom