Question regarding Mandatory Procedures and Manual

Hi everyone, i was wondering if you could explain to me the
"mandatory" procedure requirements in relation to the the
quality manual (in reference to AS9100 Rev. B)

Looking on this site the following were noted as required:
4.3 Configuration Management:
7.5.1.2 Control of Production Process Changes:
7.5.1.3 Control of Production Equipment, Tools and Numerical Control Machine Programs:
7.5.3 Identification and Traceability:
8.2.4.1 Inspection Documentation:
Control of Documents
Control of Records
Control of Nonconforming Product
Corrective Action
Preventive Action
Internal Audits

Does that mean when it comes to the actual quality manual, you
don't need to have every part of this for your company? Or the
manual is generally the same but you don't need to have procedures
for every aspect listed?

For example, 7.5.5 is listed as preservation of Product. But i don't
see this as one of the mandatory procedures, so does this still
need to be included in the manual but no procedure required or not
included in the manual?

any and all guidance much appreciated

From what I can remember, when its posted mandatory, you'll need to have a controlled document that addresses the line items depending on which "process document" is appropriate being it as a procedure (WI, SOP etc) or manual (reference, guideline etc).

You need to check your process carefully whether or not a line item is applicable to you. If it is then it needs to have a "process document".

I hope this helps

Typically, product preservation is dealt with as an instruction. For example, as part of a storage process or after machining and inspection, the parts may go for oiling etc. In my experience it's an instruction 'hung' on to a higher level process - manufacturing, assembly, etc.

AndyN said:

Typically, product preservation is dealt with as an instruction. For example, as part of a storage process or after machining and inspection, the parts may go for oiling etc. In my experience it's an instruction 'hung' on to a higher level process - manufacturing, assembly, etc.

Click to expand...

Thank you for the response - that would make sense, but when you say that it is an instruction 'hung' on to a higher level process, does that mean there is a procedure or it is within another procedure.

As i looked at the specific section it says: "The organization shall preserve the conformity of product during internal processing and delivery to the intended destination". So my question is, will the manual be fine in itself to meet this requirement?

i ask because i don't want to place us in a tight corner where all of a sudden we have a procedure and yet something comes up and we do preserve the part but say not to the point as noted on the procedure. Wouldn't we be docked for that rather than just having a "general" application of the manual?

This follows through with all the other sections of the AS9100 Manual. i don't want us to be so tight on every aspect...

any help will be much appreciated.

As far as AS9100 is concerned the “mandatory” procedures are defined as “documented procedures”.

Example:

brandnew said:

As i looked at the specific section it says: "The organization shall preserve the conformity of product during internal processing and delivery to the intended destination". So my question is, will the manual be fine in itself to meet this requirement?

Click to expand...

You could specifically put it in the manual if you want, but you don't have to. You have to have a process. Does it have to be documented? (The six aforementioned procedures aside) No. Your company decides when documentation of processes is required.

Just a comment on HodgePodge's explanation, a common mistake that is often made: "process" and "procedure" are often confused. The standard refers to "documented procedures" (six required ones), not "processes". This means that regardless of how many more than these six your organization needs, these are obligatory. The standard also requires that although only these six are required to be documented, if your organization has processes that have risk of failure, that procedures are required for them as well.

I hope this helps some.

The six mentioned above are the six items that need to be covered in a documented procedure for ISO 9001. AS9100 has a few more. Depending on how you count them, the total seems to be between eight and ten. They can be covered individually of by combining more than one or even by covering each individual one in more than one procedure. For reference, see Note 1 of 4.2.1. Please note that AS9100B is not as detailed as ISO 9001:2008 on this note, but AS9100C will align with ISO 9001:2008.

4.2.2 b requires that whatever procedures you have determined as needed for your quality management system (and must include the required ones) be either included in or referenced in the quality manual. AS9100B further requires that when referenced the relationship between AS9100B and the documented procedures be clearly shown.

Make sure you address all of them, not just the ISO six.

But if you are planning for Rev.C,the requirement of referencing is dropped.