SBS - The Best Value in QMS software

Contract Manufacturer Do they need a complaint procedure?

#1
Good Morning,

in regards to the FDA would a contract manufacturer need a complaint procedure? We wouldn't get end user complaints because we don't distribute or sell to the end user, we manufacture for the company that designed and developed the device and they would get any complaints. If we did get a complaint from our customer (the company that designed and developed the device), it would come in the form of a SCAR. So do we need a complaint procedure? Would this justification work as an exception for that clause in 13485 too? Thank you
 
Elsmar Forum Sponsor

indubioush

Quite Involved in Discussions
#2
At the least, you need to have a feedback process to comply with section 8.2.1. Regarding whether to have a complaint handling procedure/process, I suggest you have a conversation with your customer regarding expectations for performing any activities associated with the complaints section of the standard. It could be that only some requirements apply to you. For example, you may be handling complaint related product at some point, and you will need a process for that. But you won't be expected to report to regulatory authorities. If you are expected to comply with some items in this section, you can alter your existing procedures for compliance. You are not required to have a separate "complaint handling" procedure to comply.
 
#4
I don't know how exactly SCAR works from a process perspective, and it seems to be a proprietary concept. However, we don't you call the procedure you are using to process the SCAR "customer complaint management" and describe in addition a short possibility to process other feedback in a similar manner. Then you would have a complaint procedure. From my perspective as part of the quality management system you need some kind of procedure to process complaints of your customers, however this is. So you would be done with this.
 

pziemlewicz

Involved In Discussions
#8
The listed manufacturer should be responsible for complaint handling and agency notifications. I would expect you to have a Corrective Action process in place. Unsure if you are 13485 certified or not, but might be worth having a conversation with your customer surrounding expectations of "undue delay" as cited in the standard.
 

Cthames

Involved In Discussions
#9
I meant, if there was a complaint regarding the product from our customer, that would be sent via a Supplier Correction Action Request, since we are their supplier.
I would document this. Make a complaint or feedback procedure and explain how you are a contract manufacturer and don't interact with end-users, but you still process and evaluate feedback and complaints from your customers.

I would still create a complaint handling document. What if you end up with a complaint from a customer, but they don't provide you with a formal SCAR? You would still be required to process the complaint. In your procedure, you can note that you are often provided with complaint handling documentation by the customer, but that you will use your internal document if this is not provided to you by the customer.

You don't have to make a traditional complaint handling procedure, as you are a contract manufacturer and not a manufacturer. But you are still required to evaluate feedback and complaints from your customers. It appears you are already doing this, so you should document it and take credit for it. Don't burden yourself with the new procedure, just use it as an opportunity to document what you are already doing.
 
Thread starter Similar threads Forum Replies Date
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S Does Contract Manufacturer need to issue Food Grade certificate for finished device? US Food and Drug Administration (FDA) 1
A Does my firm need to list a Contract Manufacturer under Establishment Listing? Other US Medical Device Regulations 13
S Who is technically and legally a "Contract Manufacturer"? ISO 13485:2016 - Medical Device Quality Management Systems 4
E Component manufacturer or contract manufacturer ? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
M How Specific in an ISO 13485:2016 Scope for a Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 9
H Obligations as a contract manufacturer during an MDSAP audit ISO 13485:2016 - Medical Device Quality Management Systems 5
H 510k with Contract Manufacturer Other US Medical Device Regulations 2
E Contract manufacturer FDA requirements foreign company US Food and Drug Administration (FDA) 6
M We are looking for a Contract Manufacturer US Food and Drug Administration (FDA) 2
L Sample Procedure from Contract Manufacturer Prospective ISO 14971 - Medical Device Risk Management 1
I Is the contract mfg. mentioned in legal manufacturer EC certificate? CE Marking (Conformité Européene) / CB Scheme 4
S Can a Contract Manufacturer "release" product on behalf of client to the market? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
R FCC certification (contract manufacturer) TL 9000 Telecommunications Standard and QuEST 1
M Contract manufacturer MDR Quality Management System (QMS) Manuals 1
K Reporting a Change of Contract Manufacturer for a 510(k) cleared device Other US Medical Device Regulations 5
O Identifying KPI for AS9100 8.1.4 - Prevention of Counterfeit Parts - PCB assembly contract manufacturer AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
M Medical Device Master File - We are a contract manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 10
D Software Validation - Contract manufacturer of Components (PCBA's) Qualification and Validation (including 21 CFR Part 11) 7
J Contract Sterilization - Our company is a contract manufacturer Manufacturing and Related Processes 8
R Contract Manufacturer/OEM Supplier - We are a specification developer for a kitted product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Legal Manufacturer FDA Reporting Obligations for Using New Contract Sterilization Site Other Medical Device Regulations World-Wide 0
leftoverture REACH Compliance - Small, family-owned contract manufacturer REACH and RoHS Conversations 16
R 21 CFR Part 820 Contract Manufacturer of Medical Device Component 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
Ed Panek Bringing Production in house from Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 3
M ISO 80079-34 certified contract manufacturer needed Other ISO and International Standards and European Regulations 2
Ed Panek Observational Audit of Contract Manufacturer Production ISO 13485:2016 - Medical Device Quality Management Systems 5
S Is it okay to store the design files (device drawings) at contract manufacturer location? ISO 13485:2016 - Medical Device Quality Management Systems 6
M Contract Manufacturer of a Finished Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 5
D EU MDR - Contract Manufacturer vs Legal Manufacturer EU Medical Device Regulations 4
I Certificate of Exportability - Contract manufacturer located outside the US 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S Is company “A” a contract manufacturer, a labeler, or a repackager 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
S Integrating a Contract Manufacturer's documentation into our Quality System ISO 13485:2016 - Medical Device Quality Management Systems 3
J Medical Devices sourced from Contract Manufacturers - Who is the legal manufacturer? EU Medical Device Regulations 13
S Question about ISO 13485:2003 - Production Provisions - Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 10
S Contract Manufacturer Question - Whether or not the reference to the ex-CMO ISO 13485:2016 - Medical Device Quality Management Systems 6
R Sterilization Adoption - Design House - Adoption Letter from Contract Manufacturer EU Medical Device Regulations 3
Ajit Basrur Can a Contract Manufacturer Delist a Device upon Discontinuation of Manufacturing? Other US Medical Device Regulations 1
H Who is the Legal / Labeled Manufacturer? (Contract Manufacturers shipping to the EU) ISO 13485:2016 - Medical Device Quality Management Systems 1
N "Sterile" missing on the CE Certificate - ISO 13485 Certified Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 5
N UDI implementation with contract manufacturer Other US Medical Device Regulations 2
somashekar Pre-Announced FDA 4 Day Inspection, Class 2 Devices, Contract Manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
W Shared Responsibility Between Spec Provider and Contract Manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S Device Master Records for a Contract Manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
N FDA - Change of Manufacturings Site to Contract Manufacturer in China 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M Contract Manufacturer 510K Starting Point 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
P Process Validation of inherited tooling by Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 4
N Contract Manufacturer EC Certificate Scope ISO 13485:2016 - Medical Device Quality Management Systems 8
S Should a contract manufacturer for components be filing MDR exemption? US Food and Drug Administration (FDA) 1
J Import of an Investigational Device from a Contract Manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9

Similar threads

Top Bottom