ISO 9001 Clause 4.2.4 - Records of Conformity question

John Broomfield

Staff member
Super Moderator
#11
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.
djbeatsent,

This is why you plan your verifications per clause 7.1c, conduct the verifications per the plan and record them per 7.1d.

You may have a general inspection and test plan which you can then tweak for each product, order or customer.

Then you keep the records per 4.2.4.

John
 
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Jim Wynne

Staff member
Admin
#12
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.
Here's the part of 4.2.4 (ISO 9001:2008) in question:
"Records established to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled."

This doesn't say anything about records of conformity being required, per se; it says that if there are such records, they must be controlled. If you've determined what records are needed for your processes, those records must be controlled.
 
R

RDQuality

#14
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.
Please refer to Section 8.2.4 "Evidence of conformity with the acceptance criteria sahll be maintained" In your circumstance, all that is needed is for you to record something as follows: " On 2/23/2011, 34 of 35 widgets passed the tolerance requirements of document 269WR87 Rev. 1 on Contract Number W8934D68 Issue 3.
Again refer to Section 8.2.4 "Records shall indicate the person(s) authorizing release for deliveryto the customer". The person is the one performing the inspection and the customer may be the next stage in the production line or the final custmer, etc. so in addition to recording the number of pieces passing the acceptance criteria, document number, contract number and date, the inspectors name, initial, inspection stamp or other identification must also recorded on the record.

If the inspection gate is located on the traveler, the inspectors initials, signature or stamp affixed on the appropriate traveler gate might be sufficient as long as the traveler is maintained as a record.
 
R

RDQuality

#15
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.
Please refer to Section 8.2.4 of the standard. "Evidence of conformity with the acceptance criteria shall be maintained" In your circumstance, I be leive all you have to have as a record is something like this: On 2/1/2011, 34 of 36 widgets passed the dimdntional tolerance requirements of document 34XK 2874 Rev 2 Contract Number 35683MVW. the contract number may be optional. In addition, please refer to Section 8.2.4 again: " Records shall indicate the person(s) authorizing release of the product for delivery to the customer." The person is the inspector and the customer could be the next manufacturing operation or the actual cusomter. So the inspector must also include his(her) signature, iniitials, inspection stamp ro other identifier on the record.

If the inspection gate is depicted on the traveler and a copy of the traveler is maintained a s arecord, the inspectors signature, initials, inspection stamp or other identifier could be affixed to the traveler to confirm the required inspection has been performed.

I hope this has helped.
 
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