W
WBubel - 2010
Where can I get help in Identifing Critical Components for Incoming Inspection?
Re: Help in Identifing Critical Components for Incoming Inspection
Records of past nonconforming conditions is a good place to start, and using contract review to evaluate those things in terms of risk is also good.
Records of past nonconforming conditions is a good place to start, and using contract review to evaluate those things in terms of risk is also good.
Re: Help in Identifing Critical Components for Incoming Inspection
Is this what you are trying to know WBubel ??
From your risk management file .... safety critical components, performance critical components, regulatory related components, and other outsourced parts which needs a validated process.
Is this what you are trying to know WBubel ??
W
WBubel - 2010
Re: Help in Identifing Critical Components for Incoming Inspection
In Incoming Inspection we are trying to Identify Critical components.
1. Is it components that could lead to the reduction in performance of the final device?
2. Is it components that could lead to the stopping or or slowing of the production line?
3. All active Components. ie transistors, diodes, Integrated Circuits, transformers.
4. All passive components. ie resistors, capacitors, inductors, brackets, knobs, switches.
5. All components big or small. :mg:
In Incoming Inspection we are trying to Identify Critical components.
1. Is it components that could lead to the reduction in performance of the final device?
2. Is it components that could lead to the stopping or or slowing of the production line?
3. All active Components. ie transistors, diodes, Integrated Circuits, transformers.
4. All passive components. ie resistors, capacitors, inductors, brackets, knobs, switches.
5. All components big or small. :mg:
P
Phil Fields
Re: Help in Identifing Critical Components for Incoming Inspection
Yes and it depends!
• What are the risks associated with your product/production?
• Are you in a regulated industry, how do the regulations define critical component?
• Do any of the parts you received effect the Safety and/or efficacy of the final product?
Phil
Yes and it depends!
• What are the risks associated with your product/production?
• Are you in a regulated industry, how do the regulations define critical component?
• Do any of the parts you received effect the Safety and/or efficacy of the final product?
Phil
W
WBubel - 2010
Re: Help in Identifing Critical Components for Incoming Inspection
We are ISO 13485, we are a regulated industry by ISO and FDA. Nothing gets out of this house if it does not meet the specified parameters and rigorious testing, so safety of the final product is not an issue. Incoming inspection is already done on all incoming stock, what I need is to identify which component is critical.
I guess I need a clear Definition of what a Critical Component is.
We are ISO 13485, we are a regulated industry by ISO and FDA. Nothing gets out of this house if it does not meet the specified parameters and rigorious testing, so safety of the final product is not an issue. Incoming inspection is already done on all incoming stock, what I need is to identify which component is critical.
I guess I need a clear Definition of what a Critical Component is.
P
Phil Fields
Re: Help in Identifing Critical Components for Incoming Inspection
We are also 13485, and regulated by 21 CFR 820. What we have done is requested that Design Engineering identify parts/components that a nonconformance would affect the SAFETY and/or EFFECACY of the final assembly or process. These are then deemed critical components.
We are also 13485, and regulated by 21 CFR 820. What we have done is requested that Design Engineering identify parts/components that a nonconformance would affect the SAFETY and/or EFFECACY of the final assembly or process. These are then deemed critical components.
Re: Help in Identifing Critical Components for Incoming Inspection
If you´re talking about safety-related componentes (as some ot the others suggested) you could use clause 4.8 "Components of ME EQUIPMENT" in IEC 60601-1. Basically, any component the failure of which could result in a hazardous situation are considered critical. There´s another situation, when a fault in a component could generate unnaceptable risk, the component has to be what the standard call a COMPONENT WITH HIGH-INTEGRITY CHARACTERISTICS in ME EQUIPMENT. This is a special kind of critical component.
There are some..nuances..in the way to define these components because it has to be arisk-based decision.
If you´re talking about safety-related componentes (as some ot the others suggested) you could use clause 4.8 "Components of ME EQUIPMENT" in IEC 60601-1. Basically, any component the failure of which could result in a hazardous situation are considered critical. There´s another situation, when a fault in a component could generate unnaceptable risk, the component has to be what the standard call a COMPONENT WITH HIGH-INTEGRITY CHARACTERISTICS in ME EQUIPMENT. This is a special kind of critical component.
There are some..nuances..in the way to define these components because it has to be arisk-based decision.
Wes Bucey
Prophet of Profit
Re: Help in Identifing Critical Components for Incoming Inspection
I wonder if you really mean the terms of art: "critical characteristics" and "critical attributes" which determine the fitness for use of an incoming material or product which may be used whole or as a component of a product or assembly.
If so, engineers and other functions within the manufacturing environment and often at the next customer in the supply chain often collaborate on determining which characteristics (measurable physical dimensions or properties) or attributes (color, surface appearance, nicks, scratches, etc.) are absolutely critical to the fitness for use and then consider which of these characteristics or attributes are most likely to be nonconforming as a result of previous processes in the supply chain. If you need some concrete examples of such critical characteristics or attributes, say so, and many Covers here will be able to supply such examples.
Typically, this list of critical characteristics created from the collaboration is very short so that an incoming lot or shipment can be quickly evaluated for acceptance based on these characteristics (versus measuring EVERY dimension and assessing every attribute.)
I hope this helps you clarify what you are asking us to help you with.
I wonder if you really mean the terms of art: "critical characteristics" and "critical attributes" which determine the fitness for use of an incoming material or product which may be used whole or as a component of a product or assembly.
If so, engineers and other functions within the manufacturing environment and often at the next customer in the supply chain often collaborate on determining which characteristics (measurable physical dimensions or properties) or attributes (color, surface appearance, nicks, scratches, etc.) are absolutely critical to the fitness for use and then consider which of these characteristics or attributes are most likely to be nonconforming as a result of previous processes in the supply chain. If you need some concrete examples of such critical characteristics or attributes, say so, and many Covers here will be able to supply such examples.
Typically, this list of critical characteristics created from the collaboration is very short so that an incoming lot or shipment can be quickly evaluated for acceptance based on these characteristics (versus measuring EVERY dimension and assessing every attribute.)
I hope this helps you clarify what you are asking us to help you with.
W
WBubel - 2010
Re: Help in Identifing Critical Components for Incoming Inspection
I am Design Engineering, and I would consider any active component in a device which could fail during a medical procedure and causing the device to become inoperative or degraded as being critical. Active components are any semiconductor device (transistors, diodes, IC's) which has a voltage applied to it.
However in actual use I have found that most of these devices can work for years without failure. If I declare that all active devices are critical I will be smacked in the back of my head and called a 'Putz'! I can only look at past failures and identify the failed device as critical.
Am I on the right track?
I am Design Engineering, and I would consider any active component in a device which could fail during a medical procedure and causing the device to become inoperative or degraded as being critical. Active components are any semiconductor device (transistors, diodes, IC's) which has a voltage applied to it.
However in actual use I have found that most of these devices can work for years without failure. If I declare that all active devices are critical I will be smacked in the back of my head and called a 'Putz'! I can only look at past failures and identify the failed device as critical.
Am I on the right track?
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