IATF 7.1.5.2.1 Calibration/verification records :Program/software verification

#1
Hello,

During IATF audit, the auditor asked about the moisture content equipment (verification of humidity percentage of plastic row material after drying), in this equipment every row material has its program, here he asked how we validate/verify the program: here we responded that we validate the program by the verification of the result of the test and compare it with the material datasheet, but also we mentioned that during calibration of equipment, to verify the equipment we start one program and perfrom the calibration , but there is no prove: no in calibration certificat, no any document,

so my question : how to verifiy the software or program of an equipment? how to respond to how did you validate the program ?

thank you guys :)
 
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John C. Abnet

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Super Moderator
#3
Good day @ghanfari
Could you please share the exact verbatim nonconformance as written by the CB?

This will better help us reply to your situation. Thank you.

Be well
 
#4
good day,

here the nonconformance as written by the CB:

Statement of nonconformity
Calibration record control not fully effective.
Objective evidence
Evidences for the verification that the software or program version used for the control of the residual moisture applicable for the Mettler-Toledo
could not be submitted during the audit.
Justification for classification
List of used program is related to limited number of material, verification of the program with the applicable supplier recommendation led to
positve result.
All program parameters included in the soft war of the equipment (Temperature, time weight are conform to the specification).
No risk for the customer, limited risk for the quality system management of the client.
 

dwperron

Trusted Information Resource
#5
good day,

here the nonconformance as written by the CB:

Statement of nonconformity
Calibration record control not fully effective.
Objective evidence
Evidences for the verification that the software or program version used for the control of the residual moisture applicable for the Mettler-Toledo
could not be submitted during the audit.
Justification for classification
List of used program is related to limited number of material, verification of the program with the applicable supplier recommendation led to
positve result.
All program parameters included in the soft war of the equipment (Temperature, time weight are conform to the specification).
No risk for the customer, limited risk for the quality system management of the client.

I am seeing this more and more in ISO 17025 audits, where assessors are writing up labs for not having complete calibration records:

"6.4.13 Records shall be retained for equipment which can influence laboratory activities. The records
shall include the following, where applicable:
a) the identity of equipment, including software and firmware version...."

This sort of applies to your situation, and may be what the auditor was looking at, because there is the 16949 requirement for calibration records:
g) verification that the software version used for product and process control is as specified

I am guessing that he wants to see software / firmware revisions in your calibration records for the moisture analyzer, and that the revision matches what your process calls for it to be.
 

Sebastian

Trusted Information Resource
#6
It is IATF 16949 section 7.1.2.5.1 g), but i) is also interesting.

There is equipment software prepared by equipment manufacturer, which runs according to programs designed by you.
Equipment manufacturer sets a mask and program names shall comply with this mask.
You have to take this mask into account and create program naming "procedure" to control future program revisions.
Program name could look like "123456.000" and revision "123456.001"
Also it could be named "123456A" and revision "123456B".
Calibration records shall refer full name, including ".001, or "B".
This is about controlling program revisions in a same manner as document revisions are controlled, e.g. product drawings.
 
Last edited:
#7
hello, this is the NC:

Evidences for the verification that the software or program version used for the control of the residual moisture applicable for the Mettler-Toledo
could not be submitted during the audit.

it was IATF audit
 

John C. Abnet

Teacher, sensei, kennari
Leader
Super Moderator
#8
hello, this is the NC:

Evidences for the verification that the software or program version used for the control of the residual moisture applicable for the Mettler-Toledo
could not be submitted during the audit.

it was IATF audit
Although the NC is written oddly (poorly?)...i.e. "Calibration record control not fully effective."...from what i can glean from your posts, yes...this does indeed sound like a valid NC.

From your original post..." here he asked how we validate/verify the program ?"

Is that not a valid question? Your organization has a program that delivers as result. How do we know the program is giving the correct result unless there is some type of program validation?


If you are "validating" by simply comparing to the results of the material data sheet...
1- Do you have evidence that the equipment generating the material data sheet has been validated?
2- Assuming that your internal results don't always match the material data sheet EXACTLY, what is the allowable variance from the results the material data sheet provided? Is this documented?/justified?
3- Can your organization work with the provider of the material data sheet to have their equipment calibrator assist with collaborative testing ?
4- Can your organization work with the provider of the material data sheet to establish an interlaboratory collaborative testing plan?
5- Does the manufacture provide or recommend a collaborative testing service ?

Food for thought.

Hope this helps.
Be well.
 
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