How to write an exclusion to a clause into our procedures?
2.3.4 does not apply to our program. How do I write that into procedure? Our consultant just put N/A.in our report.
Long ago, I created an SOP for handling outside contract manufacturers even though my client never used one. It just says that they will be held to the same standard as an supplier. So, for example, they need to provide a Specification, and a COA for each lot of finished product.
We don't have any outside manufacturers. We manufacture everything in house.
We don't have any outside manufacturers. We manufacture everything in house.
Exactly. So the SOP basically says, "if we had outside contractors, they would be held to the standards in the supplier SOP (which see)."
For our clients that do not have any contact manufacturers we write 2.3.4 Contract Manufacturers statement (for the benefit really of the Auditor) that the company does not presently use the services of contract manfacturers, but that in the future the company will follow the requirements of 2.3.4 and any other applicable requirements should the company decide to use a contract manufacturer.
Works everytime.
Don't know what the heck N/A on a report means.
Don't know what the heck N/A on a report means.
I'm guessing the consultant meant that the rule didn't apply to them since they don't use contract manufacturers, he put down not applicable. But as you know, like with allergens and other clauses, you can't write that.
Create it the same way you would if it were a procedure; however, in the body text say it is non applicable.
My experience you dont need to put anything into procedure because it doesn't apply. The auditor will ask you when he gets to that and you will simply say "no we dont use contract manufacturing", and they will write N/A.
It worked with like 5 auditors I had :)
I agree you don't need to do anything. you may want to create a procedure on how you would handle them.
Ive seen NAs in numerous sections.
You can't write procedure for something you don't do. 2.3.4 is a non-mandatory element for just that reason. You will however have to explain that to your auditor. Last year we had a contract manufacturer but unfortunately they went out of business a few months ago. We audited them annually for 4 years. Had a program in place and passed that section of the re-cert audit We received all of our WIP from them and that was that. Yesterday the auditor asked if we had a contract manufacturer and we said not any more. He marked it N/A and moved on.
We receive N/A submissions for a few elements. It simply means there is nothing we can do within our organization for that element- We perform no action toward it therefore there is nothing to audit.