How to risk assess tooling? For a medical device and is it needed???

Ezeta

Registered
#1
Hi all,

We are a small medical device manufacturing company and have been told by the supplier that we have to risk assess their tooling and tooling for IQ,PQ (VALIDATION) and their moulding process.

1. Where can I find info specifically related to this (standards etc)
2. Does anybody have any experience in doing this? How do I get started?

They have told us that the information needs to come from us.

Any advice would be most welcome.
sincerely
Utterly confused :/
 
Elsmar Forum Sponsor

yodon

Leader
Super Moderator
#2
One of YOUR suppliers is pushing this on you? I would expect there to be some push from your customer.

You can't really know the risk to the device without your customer's involvement. In essence, if failure from the tool (resulting in a NC part) can lead to patient harm then the severity of the harm needs to drive the degree to which you qualify the equipment and validate the process. You can maybe brainstorm on how the process can fail (PFMEA). The IQ/OQ/PQ process is a pretty standard method for the process validation. Ensure things are set up properly, find out what your process parameter ranges are, dial it in, make parts, confirm they are compliant. You can google the heck out of that.
 

Tidge

Trusted Information Resource
#3
This is just an educated guess: The supplier may be used to generating (internal to them, but asked for by other medical device manufacturers they supply) manufacturing process FMEA documents, and they (manufacturer) want you to provide the initial severities (for potential failure modes) and then to do an evaluation/assessment of the controls they've implemented as part of their process.

It is also possible (as I have observed this directly with suppliers of molded components) that the supplier simply wants to begin planning for sample sizes (and commensurate efforts) for (injection mold) tool qualification, and used a risk-based assessment to determine sample sizes and/or determining which dimensions to study.

I suppose it is also possible that the supplier simply tossed this general question to get an assessment of how serious you are!
 
Thread starter Similar threads Forum Replies Date
T AS9100D Risk-Based Internal Audit Schedule AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
thisby_ Installation Related Issues and Risk Management ISO 14971 - Medical Device Risk Management 5
W Reconciling FMEA RPN ratings with Risk Acceptability ISO 14971 - Medical Device Risk Management 11
D How to address the content deviation of 'cannot apply criteria of risk acceptability prior to...' ISO 14971 - Medical Device Risk Management 1
Doninina Risk management file according MDR or ISO 14971:P2019 ? EU Medical Device Regulations 2
T Risk based CA AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
T IVD Risk - destruction of patient samples - Harm to property? ISO 14971 - Medical Device Risk Management 5
E Do anyone have document of automotive production risk and control of risk? Lean in Manufacturing and Service Industries 1
R Using RPN to Confirm Risk Reduced to an Acceptable Level Risk Management Principles and Generic Guidelines 12
T IVD Device Software - Risk Classification IEC 62304 - Medical Device Software Life Cycle Processes 16
G Help:Risk Management - Accessories US Food and Drug Administration (FDA) 1
N Writing Risk Management procedure for small manufacturing and we don't know where to start. Manufacturing and Related Processes 9
M Clinical evaluation interface with the risk management process EU Medical Device Regulations 9
L Risk analysis Manufacturing and Related Processes 4
J Risk Analysis for Proficiency Testing Reliability Analysis - Predictions, Testing and Standards 1
J ISO 10993-1:2018 Format to Perform Risk Management Process US Food and Drug Administration (FDA) 1
B Risk Management Procedure updates needed for 14971:2019 ISO 14971 - Medical Device Risk Management 11
M What is the Risk of Using Obsolete Versions of C=0 & ANSI/ ASQ Z1.4 Sampling Plans? ISO 13485:2016 - Medical Device Quality Management Systems 8
D AS9100D 8.4.2 Note 2 Significant Operational Risk AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
A Calculating Risk Estimation ISO 14971 - Medical Device Risk Management 29
M Intended Use vs Actual Use and Scope of Risk Management EU Medical Device Regulations 8
S IDCB 0129/0160 Clinical Risk Management ISO 14971 - Medical Device Risk Management 2
H At what level (harm, hazardous situation, seq. of events, etc) is "risk" estimated? ISO 14971 - Medical Device Risk Management 12
A Risk Management Team IEC 60601 - Medical Electrical Equipment Safety Standards Series 11
S Risk Management File - Procedure Packs ISO 14971 - Medical Device Risk Management 3
B ISO 14001 Risk assesment ISO 14001:2015 Specific Discussions 4
J What risk to cover when NOT using ISO 17025 accredited/certified labs for calibration ISO 17025 related Discussions 3
G Risk Management for IEC 60601-1 and IEC 60601-1-2 IEC 60601 - Medical Electrical Equipment Safety Standards Series 15
S What is your favorite Usability Risk Analysis tool? IEC 62366 - Medical Device Usability Engineering 5
T Assessing risk where harm is indirect - Generic devices / accessories / intermediates ISO 14971 - Medical Device Risk Management 8
K Do you have separate clinical risk management group or experts in your manufactures? EU Medical Device Regulations 4
W IATF 9.2.2.1 Internal Audit how to determine risk IATF 16949 - Automotive Quality Systems Standard 12
S Risk control through Information for safety ISO 14971 - Medical Device Risk Management 12
A Derive Risk Acceptance Matrix from Risk Policy ISO 14971 - Medical Device Risk Management 8
B ERP software validation - risk assessment vs validation scope ISO 13485:2016 - Medical Device Quality Management Systems 11
I Estimation of overall residual risk. How to? EU Medical Device Regulations 11
Sidney Vianna ISO Practical Guide on ISO 31000:2018 - Risk Management Other ISO and International Standards and European Regulations 0
T IEC 62304 : Risk control for SaMD IEC 62304 - Medical Device Software Life Cycle Processes 8
T Risk Assessment and Management Misc. Quality Assurance and Business Systems Related Topics 0
P Scenario based risk assessment IEC 27001 - Information Security Management Systems (ISMS) 1
Q KPI risk assessment - Criteria for the given score IATF 16949 - Automotive Quality Systems Standard 3
S Foreign Risk Notification Canada Medical Device Regulations 2
J HELP NEEDED ! Risk Management Exercise ISO 14971 - Medical Device Risk Management 12
O Should a Covid vaccine and testing policy be included as part of ISO9001 or AS9100 risk management? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
M Does 4.5 - Alternative RISK CONTROL apply to the Particular Standards? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
Q Measurement Equipment Revocation - Looking for a Disposal Form with Risk Assessment IATF 16949 - Automotive Quality Systems Standard 10
B ISO13485 Risk managment implementation for suppliers ISO 14971 - Medical Device Risk Management 2
Moncia Chemical risk assessment / COSHH Manufacturing and Related Processes 5
Enghabashy Supply chain main policies ,scope, risk assessments & relavant KPI Supply Chain Security Management Systems 2
D Use Error Risk Controls and Control Verification ISO 14971 - Medical Device Risk Management 6

Similar threads

Top Bottom