ISO 9001 Clause 4.2.4 - Records of Conformity question

D

djbeatsent

#1
I work for an injection molding facility with many customers and many different parts. Every customer has different requirements and many of the requirements are visual/no dimensions. I personally do all of the inspections myself on a sampling schedule for each part. With most parts, I visually inspect and when when it visually does NOT look OK I will measure the parts with calipers to see if the parts are in tolerance. How can I possibly provide records showing conformity and meet ISO requirements? If I were to write down every dimension shown on a drawing for 2 or 3 parts per run, 100% of my time would be occupied running around writing numbers down.
 
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K

keres

#2
Re: ISO 4.2.4 Records of Conformity question

Try to create some kind of form in which entering data spend minimum time.
You will agree with me collecting data is a ground step for improvement.
 

SteelMaiden

Super Moderator
Super Moderator
#3
Re: ISO 4.2.4 Records of Conformity question

Can you log what has been visually passed/failed and what has been dimensionally passed/failed? (along with what characteristics failed of course)
 
D

djbeatsent

#4
Re: ISO 4.2.4 Records of Conformity question

Can you log what has been visually passed/failed and what has been dimensionally passed/failed? (along with what characteristics failed of course)
What do you mean? I currently keep a log of all nonconforming parts and they'
re issues. It's the passed parts I am not sure about. What might that log look like?
 
M

miwriter

#5
In my previous work, we have this record showing an illustration of the product and has a table with pass/fail column to indicate visual/dimensional inspection results of critical parts of the product..this is regularly checked/measured..in case there are areas that failed and additional check is needed, the additional area or part checked/ measured is encircled in the illustration and noted in the remarks portion
 
H

Houcka

#6
Re: ISO 4.2.4 Records of Conformity question

What do you mean? I currently keep a log of all nonconforming parts and they'
re issues. It's the passed parts I am not sure about. What might that log look like?
You could go with something as simple as a log where you document the date, the unique part identification, the approving authority (that would be you) and a checkmark for pass or fail. You may want to add a comment line or NCR reference field in the event the product doesn't pass so as to document where the product failed to meet requirements.
 

SteelMaiden

Super Moderator
Super Moderator
#7
Re: ISO 4.2.4 Records of Conformity question

What do you mean? I currently keep a log of all nonconforming parts and they'
re issues. It's the passed parts I am not sure about. What might that log look like?
Just use a pass/fail column? See the next two posters for some ideas, these are the kinds of things I was thinking about.

In my previous work, we have this record showing an illustration of the product and has a table with pass/fail column to indicate visual/dimensional inspection results of critical parts of the product..this is regularly checked/measured..in case there are areas that failed and additional check is needed, the additional area or part checked/ measured is encircled in the illustration and noted in the remarks portion
You could go with something as simple as a log where you document the date, the unique part identification, the approving authority (that would be you) and a checkmark for pass or fail. You may want to add a comment line or NCR reference field in the event the product doesn't pass so as to document where the product failed to meet requirements.
 
D

djbeatsent

#8
Re: ISO 4.2.4 Records of Conformity question

Thats perfect. A pass fail/collumn would be the ideal way to not have to record all those readings all day long but still meet ISO requirements...thank you!

I thought of something like that before but I interpreted ISO stds as saying that actual dimensions has to be recorded.
 
J

Jeff Frost

#9
How can I possibly provide records showing conformity and meet ISO requirements? If I were to write down every dimension shown on a drawing for 2 or 3 parts per run, 100% of my time would be occupied running around writing numbers down.
Look at keeping your record process simple and as uncomplicated as possible and think of records this way:

1) Traveller: Is the record of the manufacture and inspection of the product as it moves through your system and as such will show loss of product during manufacture, inspection acceptance and approval for shipment.

2) Drawings: Use a copy of the drawing to record key and critical dimensions directly next to the requirement showing the high and low results and once completed have the inspector date and stamp (or sign) the drawing to serve as the record of inspection results. Attach this drawing to the traveller.

3) Nonconformity report: Use this form as intended and write report number on traveller at the inspection operation to show loss of product quality. Once the disposition is made attach copy to traveller to provide a record of the action taken

If you feel the need to maintain a log for the inspection process this could be done on a simple Excel spread sheet and could be as simple as date, traveller number, quantity accepted, quality rejected, NCR number and inspected by.


I visually inspect and when when it visually does NOT look OK I will measure the parts with calipers to see if the parts are in tolerance.
This comment would cause me some concern if I were your customer. It is a requirement for your organization to meet surface finish details, dimensional details and color requirements per the drawing, specification and PO requirements for each and every order.
 

somashekar

Staff member
Super Moderator
#10
I work for an injection molding facility with many customers and many different parts. Every customer has different requirements and many of the requirements are visual/no dimensions. I personally do all of the inspections myself on a sampling schedule for each part. With most parts, I visually inspect and when when it visually does NOT look OK I will measure the parts with calipers to see if the parts are in tolerance. How can I possibly provide records showing conformity and meet ISO requirements? If I were to write down every dimension shown on a drawing for 2 or 3 parts per run, 100% of my time would be occupied running around writing numbers down.
Hi djbeatsent.
All different parts of different customers are tooled and as the tool is., so the dimension, provided your processing is well under control.
Now visual inspection is an attribute where you will have several points or areas to see and decide the pass or fail. So your sample schedule perhaps has a check box with all attributes that needs a visual check, and a check done in the box means meets visual requirement. This is one of the record.
What I do not understand is why a visual fail part goes to measurement. How would you decide visually a varible defect is a dimension nonconformance, unless you have a gage that tells you as an attribute a go/nogo on any dimension ?
Even when your attribute check record shows a fail, it gets into your production record, and for any such sample that has failed, your offline corrective action process can look at it perhaps with more dimensional details to decide on the necessary corrective action, and this will become the record of data analysis and CAPA further.
 
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