3 replies to this topic

[ganeshkashinath]

Dear All ,

 

I have been redoing the FSMS manual as per the 2018 version. My question is what exactly should level I contain ? apart from the scope , R&A, organogram etc.. Why do most of the level 1 manual have the  same sentences as standard with only the company  name instead of the word  organization ,

 

for example the standard states ,

 

"The organization shall determine external and internal issues that are relevant to its purpose and that affect its ability to achieve the intended result(s) of its FSMS. " and in the level 1  manual,  it states " Cibus Technologies shall determine external and internal issues .................................result(s) of its FSMS .

 

is it a method of internalization of the standard ? 

 

Please let me know . 

[Charles.C]

 

Dear All ,

 

I have been redoing the FSMS manual as per the 2018 version. My question is what exactly should level I contain ? apart from the scope , R&A, organogram etc.. Why do most of the level 1 manual have the  same sentences as standard with only the company  name instead of the word  organization ,

 

for example the standard states ,

 

"The organization shall determine external and internal issues that are relevant to its purpose and that affect its ability to achieve the intended result(s) of its FSMS. " and in the level 1  manual,  it states " Cibus Technologies shall determine external and internal issues .................................result(s) of its FSMS .

 

is it a method of internalization of the standard ? 

 

Please let me know . 

 

 

Hi ganeshkashinath,

Not sure what you mean by "level 1 manual" ? or internalisation ?

 

The "Quality manual" per se is sometimes also designated a "Policy Manual".

 

Minimally It contains responses stating how the "requirements" of the Standard will be met.

 

One (minimalistic) response is therefore to "reverse engineer" the text of the Standard. (maybe = internalization ?)

Edited by Charles.C, 22 September 2020 - 06:36 AM.
edit

[ganeshkashinath]

Hi , apologies for the late reply . 

 

Thank you  Charles  for the information . I address how  the requirements are met  in SOP at level II . Most of the  manuals I have come across , just change the statement as I mentioned  in the original post and refer to level l . I am not able to get the logic behind it . 

 

Also . can you give an example of the standard being reverse engineered ,

 

Best Regards,

Ganesh 

[Charles.C]

Hi , apologies for the late reply . 

 

Thank you  Charles  for the information . I address how  the requirements are met  in SOP at level II . Most of the  manuals I have come across , just change the statement as I mentioned  in the original post and refer to level l . I am not able to get the logic behind it . 

 

Also . can you give an example of the standard being reverse engineered ,

 

Best Regards,

Ganesh 

Hi Ganesh,

 

I think I deduce that yr Level 1 is the Quality Manual and level 2 contains related Procedures. This is a common approach.

 

It appears that yr quoted Quality Manual has utilised an even simpler compositional technique  than the example I give below. But  perhaps more semantically/auditorially questionable

 

 

A simple example of reverse engineering for iso22000:2018 -

 

5.3.1 The assignment, communication and understanding regarding the responsibilities and authorities for appropriate roles have been ensured by Top management.

Edited by Charles.C, 05 October 2020 - 01:35 PM.
revised