Do Contract Manufacturers 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
#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.
 
#10
Hello

I would have a complaint procedure because your customer might have a complaint that doesn't come from an end user.

Imagine the customer complains that the pallets are dirty, or the pallets are mixed / the order is wrong.

Just from a customer satisfaction point of view, it is good to have a procedure in place to investigate why did the error occour... the root cause and corrections / CAPAs.

Maybe in your case the complaints won't end up in a vigilance case, but you can put a quick tick box to say « non-vigilance ».

Remember the ISO 13458 was an evolution of the ISO 9001, so the auditor will still be looking to see how you get feedback from your customer, and how you treat that information and incorporate it into your SMQ.

I'd be interested to hear how it went with your auditor :)

Tom
 
Thread starter Similar threads Forum Replies Date
T Selection Of Contract Manufacturers Supplier Quality Assurance and other Supplier Issues 2
A Requirements for Contract Manufacturers Other Medical Device and Orthopedic Related Topics 3
Nikki9154 MDSAP inquiry for China Contract Manufacturers ISO 13485:2016 - Medical Device Quality Management Systems 5
JoCam FDA Registration for Sub-contract manufacturers Medical Device and FDA Regulations and Standards News 2
K ANVISA B-GMP Auditing requirements for Contract Manufacturers Other Medical Device Regulations World-Wide 1
A What if Contract Manufacturers does not have an ISO 13485 certificate? Where will the NB audit take place, at legal mfg. site or contract mfg. site? Other Medical Device Regulations World-Wide 3
M Contract Manufacturers and MDF Responsibilities, ISO 13485:2016, Clause 4.2.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
B Non Applications in ISO 13485:2016 for component contract manufacturers 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
H Who is the Legal / Labeled Manufacturer? (Contract Manufacturers shipping to the EU) ISO 13485:2016 - Medical Device Quality Management Systems 1
S Is FDA Establishment Registration for Bulk packaging Contract Manufacturers ? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Q FDA Requirements for Contract Manufacturers and OTC products US Food and Drug Administration (FDA) 4
C FDA requirements for Contract Manufacturers Document Control Systems, Procedures, Forms and Templates 1
T PPAP Requirements for Contract Manufacturers APQP and PPAP 4
M New Medical Device Contract Manufacturers Excise Tax Requirements US Food and Drug Administration (FDA) 8
B DMR (Device Master Record) For Contract Manufacturers 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
somashekar CMDCAS ISO 13485 for Contract Manufacturers Canada Medical Device Regulations 7
A How are Contract Manufacturers different from OEM Manufacturers? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 20
M Implementing Risk Management for Contract Manufacturers - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 12
C Risk Management for Small Contract Manufacturers ISO 14971 - Medical Device Risk Management 20
Q ISO 14971 for Contract Manufacturers - Extensive risk management ISO 14971 - Medical Device Risk Management 16
L FDA CAPA Requirement for Contract Med. Dev. Manufacturers Other US Medical Device Regulations 4
T Korean requirements for foreign medical device contract manufacturers? Japan Medical Device Regulations 2
V Records of Obsolete Medical Device(s) for Contract Manufacturers Records and Data - Quality, Legal and Other Evidence 6
J Outsourced Purchasing for Contract Manufacturing vs more typical/simple Supplier Management ISO 13485:2016 - Medical Device Quality Management Systems 2
Melissa Contract Mfg--to Manufacturer with the FDA ISO 13485:2016 - Medical Device Quality Management Systems 4
M FDA Medical device reporting (Manufacturer in US; contract manufacturer OuS) US Food and Drug Administration (FDA) 0
R Looking for an efficient contract management solution Contract Review Process 1
W Staffing/Contract Labor Provider Service Industry Specific Topics 3
I Is SRN required for a contract manufacturer (CE-Marking product)? EU Medical Device Regulations 2
H Contract Manufacturer as Design Owner ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
MedicalDevicesCanada How to find a medical device contract manufacturer, MDSAP certified? Canada Medical Device Regulations 6
shimonv Working with a contract manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 3
G How to implement H&S and Quality Control Requirements in Contract for Potential Supplier? Contract Review Process 6
S Who is technically and legally a "Contract Manufacturer"? ISO 13485:2016 - Medical Device Quality Management Systems 4
J NCR- Failure of contract review process - NADCAP audit AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
E Component manufacturer or contract manufacturer ? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 1
J Need a contract monitoring Tool General Information Resources 0
Y Procedures on Contract Review Document Control Systems, Procedures, Forms and Templates 3
C SharePoint Contract Management Software General Information Resources 0
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M How Specific in an ISO 13485:2016 Scope for a Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 9
chris1price Contract Sterilization Service Providers ISO 13485:2016 - Medical Device Quality Management Systems 5
H Obligations as a contract manufacturer during an MDSAP audit ISO 13485:2016 - Medical Device Quality Management Systems 11
H 510k with Contract Manufacturer Other US Medical Device Regulations 2
bryan willemot Contract Review and risk managment AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
J Can signed agreements over-ride review of every "contract" under ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 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

Similar threads

Top Bottom