Document Pyramid – Level 3: Work Instructions
Recap Level 2
The previous two posts covered Level 2: Procedures, part 1 and part 2. A procedure is used to convey the overall workflow of the functional process. Enough detail is provided to ensure the procedure adds value and achieves the desired results. We learned to use the process SiPoC workflow to describe the necessary functions of the process. A defined list of what to include when describing a process is also included.
Level 3
In this 5th post in the series, we’ll jump into the third tier of the document waterfall. At this plateau, your policies and procedures are in place, as needed to realize your QMS. In the previous discussion, a hint was made to guide you in creating a work instruction. A work instruction focuses on the ‘P’ (Process) in the SiPoC workflow. Recall the SiPoC acronym is for; Supplier, [input, (Process), output], and Customer. You know that every process has each of these workflow descriptors no matter how small or large. Procedures generally define the SiPoC at a high-level using the workflow from supplier through to Customer. Procedures and Work Instructions have many similarities; however, with one primary difference, the amount of detail in a work instruction includes how the transformation is done.
At the Level 3 tier … Work Instructions provide detailed step by step instruction to ensure consistent and repeatable results in doing the transformation process (the ‘P’ in SiPoC). Use the iPo [inputs, (Process), and output] to create your work instruction. At this detail, we’re not concerned with the suppliers or customers. The supplier has provided the inputs to meet the requirements of the process and the output is built to meet the requirements of the customer. Identify the inputs and define the steps in the process to achieve the output. The ‘P’ for Process is capitalized to emphasize this is your focus. However, the inputs and the output must be defined (so we know what we are receiving is good and know the expected result of the process).
There are many different work instructions formats; step by step descriptions, recipes, pictograms, and flow charts to name a few examples. Instructions will use multiple forms and reference other information (e.g., specifications and drawings) to help the user understand and complete the process successfully. Work Instructions, as with the previous two tiers in the waterfall, use records as evidence of use and performance. We’ll dive into the deep of the final waterfall tier, Level 4 – Objective Evidence in the next post. For now, let’s cover what should be included in a work instruction.
Document Content
We know from the previous posts on Procedures that consistent content and structure help the user understand the process. Again, it is worth repeating, the standards ISO9001:2015 – 7.5 Document Information and ISO/TR 10013 Guidelines for QMS Documentation provide a baseline of the requirements of what to document in your QMS and further defines processes for creating, updating, and control of these documents.
Work Instruction Content
Purpose
Scope
Responsibility and Authority
Resource Requirements
Definitions, Inputs, and Outputs
Related / Required Documentations
Detailed Description of Activities
Records / Objective Evidence
Risks and Opportunities
Reviews, Approvals, and Revisions
Template: Procedure_Form.pdf
Document content, which shall be included in the document, is defined in a standardized way to enable clear and concise communication and training. For a Work Instruction, #7 in the list above is where you will define the steps to transform the inputs into an output. Most procedures will include 10 content sections;
These ten sections are used to create a procedure that defines the transformation of inputs to an intended output. It follows the PDCI (Plan, Do, Check, Improve) workflow cycle to increase the success of training, consistency of results, and improves outcomes. Regardless of the details and methods, the aspects shown above should be considered. The organization will define what should be included in a procedure or work instruction.
Maintain Value
As with procedures, use this simple cycle to keep Work Instructions relevant and effective instructions for process transformation;
Plan -- Train to it,
Do -- Use it / Refer to it,
Check -- Monitor the results and,
Improve -- Review results and update by process owner and interested parties,
Repeat – for risk avoidance and continual improvement.
When the results are consistently good (meet or exceed defined expectations) and improving, the procedure is effective. How do you know your procedure or work instruction is good? Let’s look at the evidence … in the next post; Document Pyramid – Level 4: Objective Evidence