Sampling Plan for Small Low Volume Shops - Biggest order was 200

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#1
Can anyone help please?

I read lots of threads here about Sampling plans and I'm still not sure what do I need to do. In my case, we make fixtures and each fixture has to be checked before sent to the customer. So we do 100% inspection, no sampling plan, and we are ISO 17025 accredited and ISO 9001:2008 certified.

Now recently we started making parts for different customers as Tier 2 and 3. Small orders, the biggest order was 200. We will be shipping 20 to 50 parts per lot.

To comply with ISO:

1. Do we need to have process or procedure for first part approval? If we do, would that be full dimensional Layout or Critical Characteristics? And if CC are not specified can I pick what characteristics to be checked, does it matter if they are attribute or variable checks?

2. In-process inspection. Is this a requirement by ISO? If it is, how do I know how often should we check, what characteristics, how often and how many? If not requested by customer can I pick the one I think are critical?

3. Right now we don’t have sampling plan. We check 100% on final inspection, characteristics that I think are critical. No request by the customer. Same question as #2

4. Does the Sampling plan apply only to check the finished product or in-process also?

5. In the near future, I think we need to implement Sampling Plan and I don't know where to start.

Any suggestions?

Thanks in advance!!!
 
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Stijloor

Staff member
Super Moderator
#2
Can anyone help please?

I read lots of threads here about Sampling plans and I'm still not sure what do I need to do. In my case, we make fixtures and each fixture has to be checked before sent to the customer. So we do 100% inspection, no sampling plan, and we are ISO 17025 accredited and ISO 9001:2008 certified.

Now recently we started making parts for different customers as Tier 2 and 3. Small orders, the biggest order was 200. We will be shipping 20 to 50 parts per lot.

To comply with ISO:

1. Do we need to have process or procedure for first part approval? If we do, would that be full dimensional Layout or Critical Characteristics? And if CC are not specified can I pick what characteristics to be checked, does it matter if they are attribute or variable checks?

2. In-process inspection. Is this a requirement by ISO? If it is, how do I know how often should we check, what characteristics, how often and how many? If not requested by customer can I pick the one I think are critical?

3. Right now we don’t have sampling plan. We check 100% on final inspection, characteristics that I think are critical. No request by the customer. Same question as #2

4. Does the Sampling plan apply only to check the finished product or in-process also?

5. In the near future, I think we need to implement Sampling Plan and I don't know where to start.

Any suggestions?

Thanks in advance!!!
Can someone help?

Thank you very much.

Stijloor.
 

jerry_Malaysia

Quite Involved in Discussions
#3
1. You should need a process for First part approval, but not necessary need a procedure for that. FA normally needs to inspect all dimensional and other required testing and other validation. If CC is not specified, usually it has to be assigned based on your FMEA.

2. In-process inspection is not required by ISO, but you have to have a process in place to ensure that the product produced are according to customer requirements. How often it needs to be check depends on consistency of process. If you have a very stable process, ie minimal variation over long period of time, you may check less. Or if you have a very capable proces ie cpk above 1.33, you may check less

3. Checking 100% at final inspection is a big MUDA, unless no other choice is available, this is very vey not recommended. You could try to make some poke yoke in the process or have a much better process control, better IPQC to reduce the final inspection frequency. Final inspection is bad because by the time you detect problem, you may have already produced many batches which needs to be sorted, repair and reject

4. I think sampling shall apply to IQC, IPQC and OQC. But maybe different inspection frequency and different level

5. I am not good in sampling plan and AQL, I leave this to other expert. Worry I will mislead you.

my 2 cents
 
T

tbsiva

#4
Can someone help?

Thank you very much.

Stijloor.
Can anyone help please?

I read lots of threads here about Sampling plans and I'm still not sure what do I need to do. In my case, we make fixtures and each fixture has to be checked before sent to the customer. So we do 100% inspection, no sampling plan, and we are ISO 17025 accredited and ISO 9001:2008 certified.

Now recently we started making parts for different customers as Tier 2 and 3. Small orders, the biggest order was 200. We will be shipping 20 to 50 parts per lot.

To comply with ISO:

1. Do we need to have process or procedure for first part approval? If we do, would that be full dimensional Layout or Critical Characteristics? And if CC are not specified can I pick what characteristics to be checked, does it matter if they are attribute or variable checks? -
Yes, ideally speaking you should have a procedure for FPA, in which you have to specify the number of parts to be checked, incase of multi cavity parts how many parts will be inspected, approval procedure etc. FPA should contain all the characteristics specified in the drawing. If CC is not specified by customer, you can pick the characteristics very well with some logic. For ex: Inputs from DFMEA/PFMEA can be considered, dimensions which are having high variation can be considered. It does not mind whether it is attribute or variable, defining CC is based on the effect it is going to create to the end user, customer or subsequent operations. for ex:If a burr is going to affect the safety of operator, it should be classified as Cc.

2. In-process inspection. Is this a requirement by ISO? If it is, how do I know how often should we check, what characteristics, how often and how many? If not requested by customer can I pick the one I think are critical?
- Though it is not stressed as a requirement, logically if you have final inspection and detect the defects at final stage, its always better to have in process inspection so that defects can be detected earlier and you can modify the process immediately.(Refer 8.2.4 of ISO/TS).. Inspection at appropriate stages to be done. What char to check - Take input from FMEA,frequency of check - Go with higher frequency during start of SOP and then based on process performance update ur control plan for less frequency of check, how many - to decide based on AQL.

3. Right now we don’t have sampling plan. We check 100% on final inspection, characteristics that I think are critical. No request by the customer. Same question as #2.
As we all know, 100% inspection is a mere waste. Please refer to AQL and select a sampling plan which is very well suitable for ur part. Also, if possible get it approved from customer.

4. Does the Sampling plan apply only to check the finished product or in-process also?
There are no such requirements. U can apply the sampling plan with logic to any sort of inspection...Incoming, in process or final... May be you should have different sampling plans for each inspection stage.
 
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S

stenna10

#6
Hi,
Shop Low-Volume Businesses are characterized by custom orders of very low quantities of product, often by a customer who doesn't want to wait a long time for delivery. If they're repetitive, you can set up dedicated cells, pull systems, and short lead times to respond to these customers. This will probably cover about 80% of your volume, but only about 20% of your customers.
 

QMMike

Involved In Discussions
#7
Ok... here is my .02 ...........

Can anyone help please?
1. Do we need to have process or procedure for first part approval? If we do, would that be full dimensional Layout or Critical Characteristics? And if CC are not specified can I pick what characteristics to be checked, does it matter if they are attribute or variable checks?
You should have a documented process for first part approval. Question I have is, are these custom parts everytime or repeat orders? If they are custom parts each time, then I would imagine you would want to do a full dimensional layout. If the parts have already been approved by the customer (PPAP, FAI, ect..) then I would only measure the criticals (or what you deem critical) at First Pcs. setup. We have many parts here (molded automotive) that our first pc. sample consists only of visual conformance and durometer.

. In-process inspection. Is this a requirement by ISO? If it is, how do I know how often should we check, what characteristics, how often and how many? If not requested by customer can I pick the one I think are critical?
We check the product at appropriate stages, do whatever makes the most sense for your company and ensures a quality product is being produced. Document the checks. In our case, we use "heat sheets" for each heat of parts we produce (again, molded rubber) the operator trims them and looks at them visually. Good parts go into a carton, bad parts go into a reject bin and number of bad parts recorded. Again - no criticals stated - do what makes the most sense.

. Right now we don’t have sampling plan. We check 100% on final inspection, characteristics that I think are critical. No request by the customer. Same question as #2
There are many different sampling plans available - I am partial to the C=0 sampling plans - see * Zero Acceptance Number Sampling Plans, Fourth Edition – Nicholas L. Squeglia

Does the Sampling plan apply only to check the finished product or in-process also?
The sampling plan would only apply to your finished product - whatever you "lot" size may be. you (your process) would determine your frequency of inprocessing inspections would be.


5. In the near future, I think we need to implement Sampling Plan and I don't know where to start.

Any suggestions?

Thanks in advance!!![/QUOTE]
 
#8
Yes, ideally speaking you should have a procedure for FPA, in which you have to specify the number of parts to be checked, incase of multi cavity parts how many parts will be inspected, approval procedure etc. FPA should contain all the characteristics specified in the drawing. If CC is not specified by customer, you can pick the characteristics very well with some logic. For ex: Inputs from DFMEA/PFMEA can be considered, dimensions which are having high variation can be considered. It does not mind whether it is attribute or variable, defining CC is based on the effect it is going to create to the end user, customer or subsequent operations. for ex:If a burr is going to affect the safety of operator, it should be classified as Cc.



- Though it is not stressed as a requirement, logically if you have final inspection and detect the defects at final stage, its always better to have in process inspection so that defects can be detected earlier and you can modify the process immediately.(Refer 8.2.4 of ISO/TS).. Inspection at appropriate stages to be done. What char to check - Take input from FMEA,frequency of check - Go with higher frequency during start of SOP and then based on process performance update ur control plan for less frequency of check, how many - to decide based on AQL.



As we all know, 100% inspection is a mere waste. Please refer to AQL and select a sampling plan which is very well suitable for ur part. Also, if possible get it approved from customer.



There are no such requirements. U can apply the sampling plan with logic to any sort of inspection...Incoming, in process or final... May be you should have different sampling plans for each inspection stage.
This is also our struggle with respect to the assembly of emergency kits. I know that 100% inspection is a waste of time and money.Our critical characteristics for sampling are (1) count/completeness of the kit or subassembly and (2) dimension of components (variable type of collected data). We are starting with the components or doing sampling on pre-production stage using NIST Handbook 133 for dimensional measurements for the number of samples and maximum allowable variability. For the finished goods, we are veering towards doing the completeness of the kit. With your industry. I think you can identity dimensions per part of the furniture and do a normal sampling plan with the same NIST standards. For your production phase, I suggest a process FMEA,
 
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