ISO 13485 Risk Management for Contract Manufacturer

C

cjssag

#1
My client is a contract manufacturer of machined metal parts. Less than 20% of their sales are to medical device OEM's and are being pushed to 13485 by them. 100% of their parts are manufactured to specific customer prints which not only specify form, fit and funtion but also the base materials to be used. Some parts are made from customer supplied material. They ship parts only to the OEM.
Only one of the parts can be considered an end product: it is intended for implant but the OEM does all the sterilization, packaging and labeling.
For the life of me, I cannot fathom what type or extent of risk management they need to do other than to ensure the raw materials they purchase and the finished parts made from them are verified to applicable customer requirements.
I'd appreciate the insight of anyone with experience in this area. Thanks
 
Elsmar Forum Sponsor
A

achorste

#2
Are they pushing the business to get 13485 certification or are they looking for risk management?

Is the business already certified to ISO 9001 or FDA regs?
 
M

MIREGMGR

#3
ISO 13485 requires risk management, i.e. application of ISO 14971 risk analysis.

It doesn't require that any particular number of risks be identified and addressed.
 
R

Roland Cooke

#4
Your process presumably follows something like this
Receive customer order.
Place raw materials request on supplier.
Receive raw materials.
Make product.
Ship product.

It sounds as if a simple process flow map, highlighting the risk management activities at each step, might suffice. So you would identify:

controls over customer orders and documentation
supplier controls
purchasing and incoming inspection controls
machining processes, which utilise appropriate equipment and staff
final inspection

Emphasise risk management activities like two-way traceability, training/competency, control of equipment (PM/calibration etc)


You should also include:
a) evidence that your RM activities are effective
b) evidence that you are reviewing the adequacy of your RM strategy at appropriate intervals
 
C

cjssag

#5
Are they pushing the business to get 13485 certification or are they looking for risk management?

Is the business already certified to ISO 9001 or FDA regs?
Thanks for your response
Currently in process for dual certification. Want 9001 for the bottom line benefits (the right reasons) but only doing 13485 because a few customers suggested it. Not covered by FDA regs.
 
C

cjssag

#6
Your process presumably follows something like this
Receive customer order.
Place raw materials request on supplier.
Receive raw materials.
Make product.
Ship product.

It sounds as if a simple process flow map, highlighting the risk management activities at each step, might suffice. So you would identify:

controls over customer orders and documentation
supplier controls
purchasing and incoming inspection controls
machining processes, which utilise appropriate equipment and staff
final inspection

Emphasise risk management activities like two-way traceability, training/competency, control of equipment (PM/calibration etc)


You should also include:
a) evidence that your RM activities are effective
b) evidence that you are reviewing the adequacy of your RM strategy at appropriate intervals
Their activity is as you cited plus a good percentage of their material is customer furnished. I sort of came to the same conclusion as you but since it is nothing more than what they will be doing under ISO9001:2000, I wanted to be sure I wasn't missing something.

Your final suggestions- a) and b) above - are "money".

Thanks very much.
 
R

Roland Cooke

#7
Well don't ignore ISO14971:2007, build that into your RM system.


Don't lose sight of the end-use of this device. The metal is going to form some or all of an implanted medical device.

That is what separates your client's activities from routine manufacturing under ISO9001:2000.

Your client needs to take into account the fact that they may well have much greater knowledge of the materials and the machining processes than the customer. (The level of knowledge varies greatly in the orthopaedic industry, depending on the situation).

So it is possible that your client will need to be proactive in assisting the customer to compile his own risk management file. Are there any issues with the type/grade of metal used: machining residues, surface oxides, strength considerations?
(The customer may well perform biocompatibility testing, but is the sample they test actually representative of what your client will be providing going forward?)

Are there any additional issues relating to the actual machining, how critical are the tolerances, how will they be checked?


I hope that provides you with some useful food for thought! :)
 
C

cjssag

#8
Well don't ignore ISO14971:2007, build that into your RM system.


Don't lose sight of the end-use of this device. The metal is going to form some or all of an implanted medical device.

That is what separates your client's activities from routine manufacturing under ISO9001:2000.

Your client needs to take into account the fact that they may well have much greater knowledge of the materials and the machining processes than the customer. (The level of knowledge varies greatly in the orthopaedic industry, depending on the situation).

So it is possible that your client will need to be proactive in assisting the customer to compile his own risk management file. Are there any issues with the type/grade of metal used: machining residues, surface oxides, strength considerations?
(The customer may well perform biocompatibility testing, but is the sample they test actually representative of what your client will be providing going forward?)

Are there any additional issues relating to the actual machining, how critical are the tolerances, how will they be checked?


I hope that provides you with some useful food for thought! :)
Those are excellent questions the answers to which I will be sure to pursue. At this moment I am certain of one thing: my client may be aware of the use to which some of his parts will be put but has no knowledge of the design considerations employed by the OEM nor does he have what I would consider superior knowledge with respect to the effects the body (or body part) would have on the material specified by the OEM.
It's certainly appropriate and wise for him to at least ask for confirmation should he have some reasoned basis for questioning the selection.
I appreciate your very valuable feedback.
 
R

Roland Cooke

#9
I hasten to add:

a) those questions were off the top of my head!
b) I am not an orthopaedics product specialist
c) I am not a metallurgist

It may well be that the final customer is expert on all this stuff - that will make your client's job very easy. My point is that it is important (from an ethical standpoint, if nothing else), to not automatically assume that is indeed the case.
 
C

cjssag

#10
I hasten to add:

a) those questions were off the top of my head!
b) I am not an orthopaedics product specialist
c) I am not a metallurgist

It may well be that the final customer is expert on all this stuff - that will make your client's job very easy. My point is that it is important (from an ethical standpoint, if nothing else), to not automatically assume that is indeed the case.
I learned too many years ago that I assume at my own peril. I am not certain how to quantify what is or isn't ethical except to say I believe we are all obligated - standards notwithstanding - to give 110%, to always strive to do better, to never do that which we know is wrong or which we believe might be wrong: in essence to never do anything that will not pass the smell test.

My chief concern for my small clients, who are low on the medical device supply chain, is not the requirements of the standards. I/We can always learn how to do that which is required - thanks to folks like yourself. That part we can control.

What we cannot control is the "blood-in-the-water", litigious environment that surrounds this industry in the USA. My clients' only protection from this uncontrollable plague, aside from insurance, is that they are small(er) fish and do not present as rich a feast as do the OEM's.

I have been through major product litigation in the past where, after two years, we were dismissed from the suit and learned that insurance doesn't cover the disruption. It was as if management's time and attention were sucked into that black hole for the duration. Day to day business suffered from it while the business' progress was put on hold.

Being a conservative, old codger I suppose my clients'
"risk appetite" is far greater than mine.
 
Thread starter Similar threads Forum Replies Date
J ISO 14971 applied to ISO 13485? Low risk class 1 devices ISO 13485:2016 - Medical Device Quality Management Systems 5
S ISO 13485:2016 - Risk-based Approach ISO 13485:2016 - Medical Device Quality Management Systems 3
S ISO 13485:2016 - How I can integrate a risk management approach in our SOPs ISO 13485:2016 - Medical Device Quality Management Systems 1
S Risk Based Approach for ISO 13485:2016 Form/Procedure ISO 13485:2016 - Medical Device Quality Management Systems 23
A Including all Processes in Risk Management - ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 8
T Struggling with ISO 13485:2016 Clause 6.2 - Level of Risk Associated with Work ISO 13485:2016 - Medical Device Quality Management Systems 3
alonFAI How to define a Risk Based Approach for Supplier Management per ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 1
B Risk Requirements to meet the explicit Risk Based Approach of ISO 13485:2016 Examples ISO 13485:2016 - Medical Device Quality Management Systems 21
L Risk Management in an IVD, ISO 13485 certified company ISO 14971 - Medical Device Risk Management 2
C ISO 13485 - Documented Requirements for Risk Management ISO 13485:2016 - Medical Device Quality Management Systems 6
somashekar What are the ISO 13485 documented requirements for Risk Management? ISO 13485:2016 - Medical Device Quality Management Systems 13
C Section 7.1 of ISO 13485 - Risk Management throughout Product Realization ISO 13485:2016 - Medical Device Quality Management Systems 7
A How to Rate a Risk Acceptability and on What Basis is it Measured? ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 7
A ISO 13485 Risk Analysis Requirements for Wound Ointments ISO 13485:2016 - Medical Device Quality Management Systems 13
M Risk management, ISO 13485 and ISO 14971 ISO 13485:2016 - Medical Device Quality Management Systems 10
M Implementing Risk Management for Contract Manufacturers - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 12
A ISO 13485 Risk Analysis - Class II Medical Device Engineering Changes ISO 13485:2016 - Medical Device Quality Management Systems 9
K What is 'output of risk management' in ISO 13485, Cl 7.3.2(e).? ISO 13485:2016 - Medical Device Quality Management Systems 7
T Risk Management Procedure Mandatory in ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 21
W ISO 13485 Risk Management in Simple Terms ISO 13485:2016 - Medical Device Quality Management Systems 22
V Planning of Product Realization - Risk Management - ISO 13485 Clause 7.1 ISO 13485:2016 - Medical Device Quality Management Systems 6
M ISO 13485 training - Understanding of intent and implementation of risk management Training - Internal, External, Online and Distance Learning 1
M ISO 13485 - Risk Assessment for medical device job shop ISO 13485:2016 - Medical Device Quality Management Systems 4
S ISO 13485 & ISO 14971 - Requirements for risk management ISO 14971 - Medical Device Risk Management 6
Ed Panek ISO 13485:2016 Section 5.5.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
D ISO 13485 scope (implantable) - Polymers for dental application EU Medical Device Regulations 9
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
A ISO 13485 procedure change and reflect to legacy manufacture items ISO 13485:2016 - Medical Device Quality Management Systems 2
D ISO 13485 & CE Certification for Surgical Gloves CE Marking (Conformité Européene) / CB Scheme 0
S Inventory Listing and ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 3
M ISO 13485:2016 Certification Scope ISO 13485:2016 - Medical Device Quality Management Systems 2
D Reports under change management | ISO 13485:2016 & ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 3
M Scope for ISO 13485 Certification of a Translation Service Provider ISO 13485:2016 - Medical Device Quality Management Systems 17
Q ISO 13485 7.5.6 Validation - Off the shelf Software ISO 13485:2016 - Medical Device Quality Management Systems 3
A ISO 13485 Certification for Resin Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 4
A ISO 13485 Sterilization Clause Applicability ISO 13485:2016 - Medical Device Quality Management Systems 7
K ISO 13485 and compliance of electronic signature ISO 13485:2016 - Medical Device Quality Management Systems 5
T ISO 13485 - Assembly instructions written vs. online ISO 13485:2016 - Medical Device Quality Management Systems 5
M ISO 13485:2016 internal audit checklist Medical Device and FDA Regulations and Standards News 5
N 93/42/EEC certification without ISO 13485 EU Medical Device Regulations 3
M How Specific in an ISO 13485:2016 Scope for a Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 9
A ISO 13485 for Class 1 Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 7
0 ISO 13485:2016 Chapter 8 Integration of the subsections ISO 13485:2016 - Medical Device Quality Management Systems 3
M Change in Constitution / Ownership of firm -------ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
E ISO 13485 QMS certification as a Supplier ISO 13485:2016 - Medical Device Quality Management Systems 8
T ISO 13485:2016 Clauses related to process matrix ISO 13485:2016 - Medical Device Quality Management Systems 3
J Can signed agreements over-ride review of every "contract" under ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 2
J Implementing an ISO 13485 QMS Software ISO 13485:2016 - Medical Device Quality Management Systems 6
Q EN ISO 13485:2016/AC:2018 - AC:2018 being stated in the applicable harmonized standard listing Other ISO and International Standards and European Regulations 1

Similar threads

Top Bottom