Do I need a procedure for the procedure's template???

E

eohara - 2008

#1
Hi all,

I find that I overthink things, so this may be another example. I am wondering if I need to document the template/format of my procedures and work instructions. We have good formats that work, and we base future SOPs and WIs on existing, to keep the same format. However, this isn't documented. Should it be? I don't want to lose the template requirements, but I don't want overkill.

Also, another reason for my question is that my company used to be GMP certified. They had a procedure that covered the procedure format. Here is a clip from it:
--------------------------------------------------------
Each SOP will have a “header” which contains the following information:

Logo Block: As referenced above in this SOP, each SOP will contain a Logo Block that includes the logo and the generic title of “Standard Operating Procedures”.

SOP Title: Each SOP is identified with a brief description of the subject matter.

SOP No: Each major SOP is identified with an SOP number, which compliments the SOP title. The SOP number is intended to simplify the referencing of SOPs to improve communication throughout the corporate involvement of implementing these procedures.

Each SOP will have a statement for the listed elements, and be preceded by a number character.

1.0 Purpose and Scope: Describes SOP need and applicability.
2.0 Policy: Describes policy in regard to the SOP.
3.0 Definitions: Explains acronyms and specific terms used within SOP.
4.0 Responsibility: List responsible parties for implementing SOP.
5.0 Procedure: Describes processes to be followed and personnel responsible for ensuring that the process is followed.
6.0 Related Documents: References the documents or procedures that will be used in conjunction with the procedure.
7.0 History: Itemizes major changes in an SOP in a chronological format (time from initial SOP issue).
--------------------------------------------------------------------

My SOPs follow the nice format listed above, but I have archived the old GMP SOP. I am wondering if I need to re-issue it.

Comments?

Thanks!!!
 
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Jim Wynne

Staff member
Admin
#2
I find that I overthink things, so this may be another example. I am wondering if I need to document the template/format of my procedures and work instructions. We have good formats that work, and we base future SOPs and WIs on existing, to keep the same format. However, this isn't documented. Should it be? I don't want to lose the template requirements, but I don't want overkill.
Will it be helpful to control the format? If so, do it.
 
P

Pazuzu - 2009

#3
No, you dont. The procedures you need to have are the big 6 as stated by ISO (Internal audits, control of records, control of documents, NC product, prev. actions, and corr. actions), and and any others that you and the company deem are required for effective management. Nowhere does ISO say you shall template in a particular formate and/or have a procedure illustrating it. How you do it is up to you and as Jim stated, if it helps, giv'er!
 
B

Benjamin28

#4
Do it!

If it were me, yes, I would have a standard format, it only helps to keep things organized, nicely formatted, standardized, and is a natural portion of a document control system.
 

SteelMaiden

Super Moderator
Super Moderator
#5
You can have a template that can be opened and completed (somewhat like a form), you can have a work instruction or sop, you can have a procedure, or you can have the template and the sop/wi/procedure. Whatever works for you, but as my esteemed colleagues have said, there is not ISO requirement for a documented procedure detailing how a procedure is formatted.
 
E

eohara - 2008

#6
Thanks everyone. I know it's not required, but it's good to hear the feedback of "do what works for the company". That's been my motto as I implement ISO. It's got to both work for us, and comply.

So, I like the idea of the form (that way I don't need all the approval signatures that an SOP/WI require). Or, another idea was to make it a "reference" document.

Thanks!:D
 
#7
Not only is a documented procedure not mandated, there is also no ISO mandate for the stuff you listed in your procedure. You are not required to have the stuff you have listed (1.0-7.0), nor a header. All of the stuff you have listed may be nice to have, or even really important at your company, but not mandated by the standard.

Remember, the more control features you have, the less flexibility you get.
 
E

eohara - 2008

#8
Not only is a documented procedure not mandated, there is also no ISO mandate for the stuff you listed in your procedure. You are not required to have the stuff you have listed (1.0-7.0), nor a header. All of the stuff you have listed may be nice to have, or even really important at your company, but not mandated by the standard.

Remember, the more control features you have, the less flexibility you get.


Good points db. So, is it safest to just base my future SOPs and WIs on the existing formats? I just don't want anything to get lost. It's worked so far though. I think the old GMP requirements threw me off a little.

Thanks!
 
#9
Good points db. So, is it safest to just base my future SOPs and WIs on the existing formats? I just don't want anything to get lost. It's worked so far though. I think the old GMP requirements threw me off a little.

Thanks!
The standard gives you a lot of leeway here for a reason. You need to have enough strictness to ensure control, but you don’t want to tie your hands. One company I was working with was really struggling on how to make the prints they generate fit their procedure. When you have that battle, your system is probably too strict.
 
L

Logic

#10
Hi all,

I find that I overthink things, so this may be another example. I am wondering if I need to document the template/format of my procedures and work instructions. We have good formats that work, and we base future SOPs and WIs on existing, to keep the same format. However, this isn't documented. Should it be? I don't want to lose the template requirements, but I don't want overkill.
--------------------------------------------------------------------

My SOPs follow the nice format listed above, but I have archived the old GMP SOP. I am wondering if I need to re-issue it.
Later Post:
So, I like the idea of the form (that way I don't need all the approval signatures that an SOP/WI require). Or, another idea was to make it a "reference" document.
============================
Eohara:

You have indicated that you are going to use the "nice format" anyway, so why is it necessary to abandon the SOP? I am a bit concerned if the main reason for not keeping this SOP active is to avoid the approval signatures that an SOP/WI require. SOP/WI should have approval signatures at appropriate levels and this would not be considered a critical SOP so the approval process should be simple.

If you had to write an SOP to cover this, I would say it is not critical to have but think of the value to a new employee who may need to write an SOP and needs to understand what is required for the sake of the company - not auditors. It is standard practice for companies who operate under GMP to have a standard format for their SOPs and it certainly makes life easier for inspectors.
 
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