Validation of Processes - Is Cl 7.5.2 applicable to bricktile firing in an oven?

M

mcenyll

#1
We are currently reviewing our QMS, and I just have some questions I need answered from experts like you guys.

We are a bricktile manufacturing plant, and we used roller hearth kiln in firing tiles. from the raw materials preparation until the glazing, we have specifications to follow as well as check points, but once these tiles are fired in the oven and there is a problem in the output, we can no longer correct it. We can make some changes in the parameters but the effect can be seen on the following batches.

Is the clause 7.5.2 applicable in this process? Thanks in advance!
 
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Helmut Jilling

Auditor / Consultant
#2
Re: Is Clause 7.5.2 applicable to the bricktile firing in an oven?

If you cannot measure or inspect the tiles after they leave the oven, for example, inspecting whether the glaze is correct or the firing made the tiles hard enough, then it may be applicable. It typically applies to any situations where you cannot inspect or measure the final product.
 
A

arin_23

#3
Re: Is Clause 7.5.2 applicable to the bricktile firing in an oven?

If you cannot measure or inspect the tiles after they leave the oven, for example, inspecting whether the glaze is correct or the firing made the tiles hard enough, then it may be applicable. It typically applies to any situations where you cannot inspect or measure the final product.
Or for that matter can not determine the quality of the final product.

I guess 7.5.2 shall be applicable here , as the product quality checks can not be conducted without adopting destructive testing methodlogy. And this process of firing the briquettes in a kiln is definitely a "special process"

Regards,


Arin
 
M

mcenyll

#4
Re: Is Clause 7.5.2 applicable to the bricktile firing in an oven?

Or for that matter can not determine the quality of the final product.

I guess 7.5.2 shall be applicable here , as the product quality checks can not be conducted without adopting destructive testing methodlogy. And this process of firing the briquettes in a kiln is definitely a "special process"

Regards,


Arin
Sir, we can still inspect visually the fired tiles and can still cut it into specified dimension to remove the defective portion and eventually used in another production line as conforming input. Can that still be considered a special process?
 
A

arin_23

#5
Re: Is Clause 7.5.2 applicable to the bricktile firing in an oven?

Sir, we can still inspect visually the fired tiles and can still cut it into specified dimension to remove the defective portion and eventually used in another production line as conforming input. Can that still be considered a special process?
Hi mcenyll,

Let us once again understand your process, are these fired tiles used as input to any other process??? Or they simply are dispatched to the customers or market after visual inspection.

If case 2 , then how do you check for the hardness,compressive strength impact and fire resistivity of the same?

Do you receive any customer complaints after they use the same in their production environment?

How does your kiln operator understand the firing is over? Does he follow any specification for that? Who designs that specification? Who approves that specification?

Regards,

Arin
 
M

mcenyll

#6
Re: Is Clause 7.5.2 applicable to the bricktile firing in an oven?

Hi mcenyll,

Let us once again understand your process, are these fired tiles used as input to any other process??? Or they simply are dispatched to the customers or market after visual inspection.
Our final product which is delivered to the customers is already the fired tiles pasted into a galvalume panel with insulation. After firing the tiles, these are inspected. Conforming tiles are used in the assembly as is. But the nonconforming tiles are segregated and disposed according to its defect. If the defect is due to a chipped edge in one portion, we deliver it to cutting section so we can cut it into smaller dimension which is still required and used in the assembly line. The dimensions used in our assembly line is 218x58mm, 104x58mm and 12x58mm. Thus, defective 218 tiles can still be cut and used.


If case 2 , then how do you check for the hardness,compressive strength impact and fire resistivity of the same?

Our final product, by the way, is assembled wall panel only. We do not sell tiles directly to customer. We assemble these in a galvalume panel and send to our mother company for selling, installation, or distribution.


Do you receive any customer complaints after they use the same in their production environment?
Occasionally, we do receive complaints but not about the hardness, compressive strength, etc. Our product passed several tests, but these are carried out/commission by the mother company/customer.

How does your kiln operator understand the firing is over? Does he follow any specification for that? Who designs that specification? Who approves that specification?
We do have a Japanese consultant before who helped us establish our production parameters. He was sent/hired by the mother company. Right now, we do have a pool of ceramics engineer in-charge of formulation and other production-related activities. We already established specification manuals as to the required moisture content, residue, pressing pressure, oven speed and temperature. We are following those standards, and in case of problems in the output, we discuss among the production, rnd and qa as to what shall be the needed adjustments.

With our set-up, is the firing of bricktiles still a special process?
 
Last edited by a moderator:

harry

Super Moderator
#7
Re: Is Cl 7.5.2 (validation of processes) applicable to bricktile firing in an oven?

We already established specification manuals as to the required moisture content, residue, pressing pressure, oven speed and temperature. We are following those standards, and in case of problems in the output, we discuss among the production, rnd and qa as to what shall be the needed adjustments.
You are already addressing the requirements of the said clause! Why keep on worrying about it? Nothing is going to change even if you rename the process - you just need to keep on doing as you describe above.
 

Helmut Jilling

Auditor / Consultant
#8
Re: Is Clause 7.5.2 applicable to the bricktile firing in an oven?

We do have a Japanese consultant before who helped us establish our production parameters. He was sent/hired by the mother company. Right now, we do have a pool of ceramics engineer in-charge of formulation and other production-related activities. We already established specification manuals as to the required moisture content, residue, pressing pressure, oven speed and temperature. We are following those standards, and in case of problems in the output, we discuss among the production, rnd and qa as to what shall be the needed adjustments.

With our set-up, is the firing of bricktiles still a special process?
This is the part that seems to meet 7.5.2 perfectly. You have determined the process parameters that are required to predictably make good tiles. And you do a destructive test from time to time to ensure it is actually working.

If you control this, and maintain it, then you got it. 7.5.2 is not a bad thing, and you set up the parameters to meet it. Don't even bother to try to exclude it. It is a good thing.
 
#9
Re: Is Cl 7.5.2 (validation of processes) applicable to bricktile firing in an oven?

You are already addressing the requirements of the said clause! Why keep on worrying about it? Nothing is going to change even if you rename the process - you just need to keep on doing as you describe above.
I believe that Harry is correct.

If there is something about the final product that could be wrong and you cannot tell without destructive testing, then you need to validate.

It also sounds like you do indeed validate. That looks like the purpose of setting the the process control parameters. Following these parameters is essentially following a "recipe". For evidence of validation, if you don't already do so, you should keep records of those parameters. Oven temps, bake times, and the like. Some places use oven recorders as evidence that they have followed the "recipe".
 
M

mcenyll

#10
Re: Is Cl 7.5.2 (validation of processes) applicable to bricktile firing in an oven?

thanks to all of you guys...

actually that was my premise before, we already setup everything. But our CB auditor said it is not enough, we must show other evidence that it is controlled since it is a special process.

But now I am enlightened, thanks a lot.:thanx:
 
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