Hello,

I would like to know do you have to use WI or can you just be general in your procedures? I did not see anywere in the standard that said you had to have WI. Example: we have one person in procurement/accounting dept. as long as we do what the procedure says(below), we do not have to have a WI or does this procedure look like a WI. Or maybe I should just add this in the Quality Manual and not have procedure? Hope this makes since.:confused:

This is are Procedure for Procurement.

1.0 ORDER REQUISITION
1.1 For inventory and non-inventory production items, including supplies and engineering components and services, or for any item potentially having an effect on the quality of Company products, the individual or department requiring such items shall prepare PURCHASE REQUISITION.
1.2 The requestor shall attach additional supporting documentation, as appropriate.
1.3 If subcontracted services are being requested, the PURCHASE REQUISITION shall include:
•A complete description of the service to be performed; and
•Engineering/technical drawings and specifications (e.g., process maps, flow diagrams), as appropriate.
1.3 The requestor shall submit the PURCHASE REQUISITION and any attachments to the Procurement department. Procurement shall analyze the terms, supplier, pricing, quantity breaks, etc., and order according to the Company's (and its customers') best interests.
1.4 Only organizations and individuals on the APPROVED SUPPLIER LIST shall be used.

2.0 ORDER PLACEMENT
2.1 Procurement shall complete a purchase order (or PO) for requested parts/materials/ services (see PURCHASE ORDER for guidance).
2.2 Any inspection requirement (e.g., First Article Inspection – see reference "C") shall be clearly referenced on the PO.
2.3 Procurement may place an order with the supplier by any of several means (e.g., telephone, fax, regular mail, e-mail, supplier's web site). The Company should require suppliers to provide confirmation orders as one of its purchase order requirements.
2.4 Procurement should follow up as required on shipping, delivery, expediting, and partial shipments of ordered items in a timely manner, to assist manufacturing with consistent production flow and other departments' operational requirements. Procurement may contact suppliers by phone, fax, e-mail, or other preferred method.

3.0 RECORDKEEPING AND MATCHING
3.1 When an PURCHASE ORDER is issued, Procurement/Accounting copy is placed in an Open Purchase Order file until items are received and accepted.
3.2 Class II items shall be received and product inspections conducted in accordance with RECEIVING AND INSPECTION.
3.3 Procurement shall match receiving and inspection paperwork to the corresponding PO. The PO with the receiving paperwork and supporting requisition paperwork shall be forwarded to Accounts Payable. Procurement shall file its copy of the PURCHASE ORDER in its Completed Purchase Order file.
For partial shipments, Procurement/Accounting retains its copy of the procurement order in the Open Purchase Order file until all items have been received and accepted.

Clause 4.2.1.d states that you need whatever documents you need to ensure control over your processes. It is left to you to decide what you need, theough the standard starts by identifying 6 core procedures that you must add.

Regarding the definition of Procedure : specified way to carry out an activity or a process. Procedures can be documented or not.
In our quality documentation system :
• Procedures are used to :
- Describe the purpose and the scope, determining the responsibility, the method of combination of relevant functions and the specified way to carry out regulations of the QMS
- Refer to supporting documents on necessity .
• Supporting documents, including decisions, regulations, notices, working instructions, technical documents, product specifications, drawings, schemes, forms etc… … are used to :
- Describe the method to perform a certain job or a group of jobs at certain positions in the process . The applied scope of supporting documents could be defined by the quality manual, procedures and quality plans
So having WI or not , that depend the complexity of the work to be done and the competence of personnel.
Regards,
Clara

If you have competent prople who contributed to the creation of the procedures, and they are happy with the level of details, then no W.I. is required.

On another matter, your examples do not define 'who' does the steps in the procedure. You mention 'Procurement' but that's a department, not a function performed by a person. I believe that's a receipe for disaster.......:notme:

Andy

Previusly I read a definition that describes the difference:

Procedure-defines Who, What, When

Instructions-defines How

I have used this as a guidline, but it is not a requirement.

If you are not working toward a mandated ISO 9001:2002 system, or other by you customers, you need only to have what works for you as long as the people using it can understan it and follow it.

The only real reference to work instructions is in

7.5.1 b) the availability of work instructions, as necessary.

So if you need them to control quality, have them - if not, don't. I preferred the statement in the 1994 version where it said something along the lines of 'documented work instructions where the absence of such could adversely affect quality'. Still not a bad guideline to use I think.

My rule is that if the information is very detailed (such as step-by-step instructions), sensitive or will probably be revised relatively frequently, I make it a Work Instruction. So, we have a rather general Procedure for process control but Work Instructions for the details of doing so (such as filling kits). As time goes on, I pull more and more detail out of the Procedures and drop them into Work Instructions. It's easier for the people who use these much shorter Work Instructions on a regular basis. Our customers (we're aerospace) really love every detail being spelled out. They wouldn't care if the detail is in the Procedure vs. a Work Instruction, but more Work Instructions are easier for me and the workers.

What I've experienced is, when documented, 1) typically workers don't follow them 2) their baggage to the internal audit process and 3) too many customers equal too many "tailored" work instructions or all customer scenarios lumped into one work instruction.

Work instructions don't have to be "documented". Workers can have work instructions as a “guide” but they are not referenced anywhere in the QMS. If work instructions are referenced in the QMS, you better follow em. Just my :2cents:

I don’t go any deeper than the procedure level. Keep it short and simple. Too often, the QMS goes way overboard.