7.2 The Special Case of Work Instructions - Optional

7.2 The Special Case of Work Instructions—Optional

Par. 7.5.1(b) of the Standard conditionally calls for work instructions as part of the QMS-controlled conditions. They are to be available as applicable and as necessary. In this way, not only is extensive discretion afforded to the QMS designer, but the requirement does not require documented work instructions. In fact, the term work instruction is not defined in the canonical texts. So why even mention the term?

The answer to this question is lost in production antiquity. Because I am somewhat ancient, I can recall the term in use over 45 years ago. Clearly, it is locked into the work center concept and the fact that we do work to create a successful enterprise. Work instructions were included in the first released Standard in 1987. In that case, it was a SHALL and required documented work instructions ^[1]. Work instructions were also noted as supplemental documents in MIL-Q-9858A, Par. 4.1, 1963, and the supplier was responsible for their control. I actually worked with these documents.

So, to make a long story short, Table 6.4 is a perfectly good work instruction. It is the type of document that is kept at the workbench level and used in day-to-day operations. Work instructions are procedures in the fullest sense of the word, as we have defined procedure within our tier III documentation hierarchy. They need not be documented but often are and form a powerful basis for a higher-tier documentation.

Typical work instructions sound like ESD operator-check work instruction, order entry work instruction, screen printer work instruction, subassembly test work instruction, vision monitors installation and configuration instructions, and tape changing instructions. The document is designed for and generally used by an individual worker, in a work center, working on a very specific task.

Work instructions can also be found embedded within a high-level procedure. An example of this format is shown in Table 7.1. In Table 7.1 we show an abbreviated three-phase front-end process for a company that receives a certificate of analysis with some of their raw material (e.g., steel rods). The process flow is from receiving to inventory to kitting. Each part of the process flow has several activities.

Table 7.1: Integrated Process and Work Instruction Document

Process Phase	Activity Description	Work Instructions
1.0 Receiving	1.1 Receiving—at dock (receiver) 1.2 Receiving inspection (QA)	1.1.1 Log in the material (F-1.1.1) 1.1.2 Check for the certificate of analysis (C of A) 1.1.3 Send C of A to QA 1.2.1 Compare material properties to C of A and log in (F-1.2.1) 1.2.2 Use RTV form if not acceptable (F-RTV-1)
2.0 Inventory	2.1 Inventory—production control 2.2 Materials movement—coordinator	2.1.1 Enter material into the MRP system—note C of A received 2.1.2 Release modified schedules to production 2.2.1 Move C of A material to special storage 2.2.2 Log in (F-2.2.2)
3.0 Kitting	3.1 Kitting—materials control 3.2 Kit release—coordinator	3.1.1 Check to see that C of A was received 3.1.2 Obtain pick list 3.1.3 Compare to BOM 3.2.1 Final inspection of kit (F-3.2.1) 3.2.2 Attach traveler (F-3.2.2) 3.2.3 Release kit to assembly

The several activities have a number of work instructions shown in the far right column. The forms required are also noted, as well as specific responsibility for the activity. An integrated format of this type is very powerful in terms of simplicity and necessary detail.

^[1]Par. 4.9.1 of ISO 9001:1987.