This is how companies usually setup their quality systems (They are actually more complicated than this but for this explanation purposes… – I hope this is OK)
First tier = Quality Manual = Will show how the company structure is built
Second tier = SOP’s is what your company will base the information from.
Third tier =
1- WI’s – Work Instructions that will describe the specifics/details of what your SOP’s are telling you to do.
2- MP – Manufacturing procedures (if apply to your industry) – Detail instructions/procedure to make something
3- IP’s – Inspection Procedures – how to inspect something
4- Spec’s – Specifications (raw materials – purchased)
Fourth tier = Forms, templates, travelers, etc… supporting documents in general
Samples per tier:
Quality Manual – Structure/list (containing a list of all documents that support the quality system – some people will structure those depending the functioning areas, others by the governing agency (ISO… etc)
SOP 001 – Production Environment = (Explains how to behave in a production environment) – I.e.; Do not use equipment if the calibration is pass the due date.
SOP 002 – Calibration Procedure = Explains what to do for in-house or outside service calibration – records keeping – frequency etc
WI 001 – Timers Calibration = Explains how to calibrate the timers (in-house procedure). It can show how to use a master timer, how to fill in the information to keep in the records or how to apply the new calibration sticker, etc.
WI 002 – Gowning = Explains in detail how to gown or un-gown in a control environment, etc…
F 001 – Calibration Form - Will trace all equipment calibration records.
F 002 – Receiving Log- Will keep all entries, when receiving shipments from suppliers.
NOTE: It does not really matter if you are starting at 001 or at 5000. What it really matters is what you have in your SOP (one can be named as quality system - will show how is structured and why, responsibilities per departments, records keeping, management functions, etc)a statement that will clarify for future traceability that there is not records prior to 5000 or that the system will start at 001 increasing as a result of usage…