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