Let’s talk about document structure in a quality environment.
Documents should be structured in a logical way and using an agreed upon style that is consistent across departments, sections and groups. If I work in accounting, I should be able to understand the structure of the documents in manufacturing as well. Won’t know how to do the work, but I should know the difference between a form and a report. My work instructions will be different, but I should be able to recognize the similarity of the document structure.
So let’s look at some of the standard items and put them in perspective.
The QMS (Quality Management System) is the document in ISO that outlines the way the business runs. It’s a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It’s aligned with company's purpose and strategic direction (ISO9001:2015). It is expressed as the organizational goals and aspirations, policies, processes, documented information and resources needed to implement and maintain it.
A standard operating procedure, or SOP, is a set of step-by-step instructions created by a business to help workers carry out routine operations. Their purpose is to achieve efficiency, quality output and uniformity of performance, while reducing miscommunication and failure to comply with industry regulations.
A work instruction describes how to perform a task, which is a more detailed portion of the procedure such as "Completing a PO" or "Ordering supplies".
You may need more detail than what’s described in the procedures. Many businesses include work instructions to aid in training, to reduce mistakes, a point of reference for jobs, etc.
A blank form is a document and is treated in the same manner. Forms should have revision control and be available only in the most current revision. Forms should not be pre-printed to avoid using an outdated form. When a form is filled out it becomes a record and other restrictions apply.
Records can include filled out forms, receipts, bills of lading (BOLs), test results, acceptance inspections, purchase orders, etc.
Reports can be in many forms and from many sources. They are generally not part of the QMS but may be retained or transmitted as records. As an example:
The test report from the vendor on the new widget is included in the data package when the item is shipped and a copy is kept in the build document package for the product.
Can also be reports or they can simply be provided by a vendor.