Short SOPs (Standard Operating Procedures) or Add to Quality Manual?

I

IanFarrell

#1
I'm building our QMS to ISO 9001 and working with a 4 tier document system. Level I is Quality Manual, Process Flowchart, etc. Level II is SOPs. Level III is task-specific work instructions. Level IV is forms.

For most aspects of the system, I have a short policy statement in the Quality Manual and a larger SOP describing the details and how a procedure is carried out. Examples are Calibration, External Audit, etc.

For some aspects, I'm having a difficult time. Specifically Preventive Maintenance and Facilities Maintenance. I just don't have enough material to make a useful SOP. Can the Quality Manual house these subsystems completely? Typically I leave Document Scope and Responsibilities in the SOP, but I'll have to sneak those into the Quality Manual.

Am I just being picky and trying to over-format everything?
 
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S

somerqc

#2
Re: Short SOPs or Add to Quality Manual?

Ian,

There is no need for the 4 levels.

ISO 9001:2000 (soon to be 2008 with no effective changes) does not require this type of structure.

Save yourself a great deal of time and only document what needs to be documented (this is allowed with ISO 9001:2000 with the exception of the "big 6" required procedures).

The company and you will appreciate a system that is useful and not full of the jargon that older quality systems were full of.

The only exception to this may be when you are a "site" of a larger corporation. Many times larger corporations will have a "required" policy manual that is sent by corporate. If you do not have this situation, just stick to documenting what needs to be documented.

This is my :2cents: but it is hard enough to get people to read the "big honking binder" no need to give them even more reasons for not reading it.

John
 
S

Saenz - 2011

#3
Re: Short SOPs or Add to Quality Manual?

I'm building our QMS to ISO 9001 and working with a 4 tier document system. Level I is Quality Manual, Process Flowchart, etc. Level II is SOPs. Level III is task-specific work instructions. Level IV is forms.

For most aspects of the system, I have a short policy statement in the Quality Manual and a larger SOP describing the details and how a procedure is carried out. Examples are Calibration, External Audit, etc.

For some aspects, I'm having a difficult time. Specifically Preventive Maintenance and Facilities Maintenance. I just don't have enough material to make a useful SOP. Can the Quality Manual house these subsystems completely? Typically I leave Document Scope and Responsibilities in the SOP, but I'll have to sneak those into the Quality Manual.

Am I just being picky and trying to over-format everything?
ISO 9001 allows the manufacturer to leave out irrelevent activities. If you don't do facilties maintenance or preventive maintenance (which makes me wonder what you do) then you don't need to write an SOP. I would, as an auditor, appreciate a very short paragraph in your quality manual that states you don't don't have need for these procedures because ----. That way you won't get asked the same question over and over again.

If the activity consists of a checklist, you can name it in the QM. If it's instructions, then you should separate them out, some SOPs are only a page long--great! I say this because you can't expect a line worker to read the QM cover to cover, and everybody loves to find their training on an activity is short and sweet.
 

Raffy

Quite Involved in Discussions
#4
hI IanFarrell,
For the Preventive & Facilities Maintenance, what we did is to based the maintenance procedure on a specific equipment, i.e. Machine PM. and that makes out life more simpler....
Raffy
I'm building our QMS to ISO 9001 and working with a 4 tier document system. Level I is Quality Manual, Process Flowchart, etc. Level II is SOPs. Level III is task-specific work instructions. Level IV is forms.

For most aspects of the system, I have a short policy statement in the Quality Manual and a larger SOP describing the details and how a procedure is carried out. Examples are Calibration, External Audit, etc.

For some aspects, I'm having a difficult time. Specifically Preventive Maintenance and Facilities Maintenance. I just don't have enough material to make a useful SOP. Can the Quality Manual house these subsystems completely? Typically I leave Document Scope and Responsibilities in the SOP, but I'll have to sneak those into the Quality Manual.

Am I just being picky and trying to over-format everything?
 
S

SteveK

#5
Hi Ian,

I tend to disagree with some of the statements thus far. You do end up with the levels you indicate if you follow ISO 9001, it is just the nature of the beast. In one of the threads I found an audit presentation covering this pointas part of audit training (cannot remember where!) – in fact taking it one step more i.e. forms become records. Although it might be seen as a burden having more than the “big 6” SOPs, there may be other reasons for having a facilities SOP e.g. your insurance company might appreciate that you have some documentation to that effect (might get more full blown request like having a Business Continuity Plan – but I won’t go there!). I have a basic SOP that might help (references other non-attached documents – but I hope it gives the idea).
:)
 

Attachments

A

A1Golfer - 2009

#6
:agree1::caution:
I'm building our QMS to ISO 9001 and working with a 4 tier document system. Level I is Quality Manual, Process Flowchart, etc. Level II is SOPs. Level III is task-specific work instructions. Level IV is forms.

For most aspects of the system, I have a short policy statement in the Quality Manual and a larger SOP describing the details and how a procedure is carried out. Examples are Calibration, External Audit, etc.

For some aspects, I'm having a difficult time. Specifically Preventive Maintenance and Facilities Maintenance. I just don't have enough material to make a useful SOP. Can the Quality Manual house these subsystems completely? Typically I leave Document Scope and Responsibilities in the SOP, but I'll have to sneak those into the Quality Manual.

Am I just being picky and trying to over-format everything?
 

Patricia Ravanello

Quite Involved in Discussions
#7
I'm building our QMS to ISO 9001 and working with a 4 tier document system. Level I is Quality Manual, Process Flowchart, etc. Level II is SOPs. Level III is task-specific work instructions. Level IV is forms.

For most aspects of the system, I have a short policy statement in the Quality Manual and a larger SOP describing the details and how a procedure is carried out. Examples are Calibration, External Audit, etc.

For some aspects, I'm having a difficult time. Specifically Preventive Maintenance and Facilities Maintenance. I just don't have enough material to make a useful SOP. Can the Quality Manual house these subsystems completely? Typically I leave Document Scope and Responsibilities in the SOP, but I'll have to sneak those into the Quality Manual.

Am I just being picky and trying to over-format everything?
Hi Ian,

No you're not being too picky, or over-formatting everything. You're right on the money.

Your overall Management System is made up of several Key Processes, which you identified, such as Internal Auditing and Calibration. You are very intuitive to recognize that "Preventive Maintenance and Facilities Maintenance" need to be in there somewhere, but where?

I faced the same dilemma the first time I tried to distinguish between the "superior/key" processes, and the "subordinate" ones.

The solution is to have an SOP called "Infrastructure, Production and Service Support". Obviously, these functions are intrinsic to how your overall system works, and the challenge is to find a way to incorporate all these "loose string" subjects that seem to be orphans, relative to the other Procedures.

These are some of the "Orphan" activities:

  • Health and Safety
  • Environmental Controls
  • Capital purchases
  • Preventive Maintenance
  • Infrastructure Support (heat, hydro, water, etc.)
  • Training on the Job
  • Plant, Facility and Equipment Planning
  • Contingency Plans
  • Work Environment
  • Personnel Safety to achieve Product Quality
  • Cleanliness of Premises
  • Production and Service Provision

Part of the reason why it's not so evident that it exists is because in some companies, it's controlled at higher levels, so the process is not readily visible, or because, some companies don't share the "Capital planning" process with their managers, although most of them contribute to it in some shape or form and with varying degrees of frequency. Also, some companies are re-active rather than pro-active, so these activities are not planned as they should be, but rather re-acted to when the need occurs...hence no defined process.

I've attached a sample Procedural Level Flow Chart which captures the process which would incorporate your troublesome "Preventive Maintenance" and "Facilities Maintenance". You'll see that it actually captures a lot of the "orphan" activities which are not captured in any other Key Process. Many of these are captured in orphan "Work Instructions" which really don't relate or link to any other processes - they truly are "support" processes.

Of course, you'll need to customize it to your facility, but I think you'll see how it fits in the "big picture", and the inputs and outputs will help you to see what's involved.

Let me know if this helps.
Patricia Ravanello
 

Attachments

Patricia Ravanello

Quite Involved in Discussions
#8
Hi Ian,

I tend to disagree with some of the statements thus far. You do end up with the levels you indicate if you follow ISO 9001, it is just the nature of the beast. In one of the threads I found an audit presentation covering this pointas part of audit training (cannot remember where!) – in fact taking it one step more i.e. forms become records. Although it might be seen as a burden having more than the “big 6” SOPs, there may be other reasons for having a facilities SOP e.g. your insurance company might appreciate that you have some documentation to that effect (might get more full blown request like having a Business Continuity Plan – but I won’t go there!). I have a basic SOP that might help (references other non-attached documents – but I hope it gives the idea).
:)

Hi Steve,

I didn't get a chance earlier to look at your attachment, before posting my response, but I think it's right on. It's somewhat of a narrative version of my flow chart, attached above.

If you have Work Instructions that define how some of these sub-processes/activities occur and who is responsible for each step, it's wise to link them to this document (I don't see an "Associated Documents" field, or inputs and outputs in the document you attached, so I imagine that might be captured in your supporting Work Instructions).

I'm sure your attachment will help Ian tremendously.

Thanks for sharing,
Patricia
 
H

honest03060

#9
Steve,

Your SOP was extremely helpful. Do you have a similar one to cover Employee motivation?

Thx,
John:agree1:
 
H

honest03060

#10
Hi Steve, Your SOP was extremely helpful. Do you have an SOP for employee motivation you could share?
Thanks
John
 
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