Procedures or Standard Operating Procedures are not created overnight, they require taking into account details and an investigation of key processes. While the concept of creating a procedure (SOP) may seem simple, not following a defined process and creating a poorly written procedure can have a significant impact on your organization.
What is the difference between a process and a standard operating procedure?
The ISO 9000 of Fundamentals and Vocabularies in terms related to processes tells us:
Process: A set of mutually related activities that the inputs use to provide an intended result.
Procedure: Specified way of carrying out an activity or a process.
In other words, a process is what WE DO and a procedure is HOW WE DO IT.
What is a Procedure (POE)?
A Standard Operational procedure is a set of written instructions documenting routine or repetitive activity followed by an organization. Using procedures is an integral part of a successful QMS, as it provides people with the information to do a job properly.
What is the objective of a Procedure?
The main objective of a Standard Operating Procedure, as the name itself implies, is to standardize the performance of an activity, to minimize errors, deviations and variations. They document how activities should be performed to facilitate consistent conformance to system quality and technical requirements and to support data quality.
How to write a procedure?
Step 1: Make a list of processes that you think need a procedure.
The best way to start with step 1 is for each process owner to talk to their teams to create a possible list of procedures.
Nobody, other than the people who work on a process on a daily basis, knows more about the process than they.
Each organization will determine the necessary procedures. Not all processes will necessarily need procedures, as it may also be that one or more procedures emerge from a process, or even the reverse that several processes are detailed in a procedure. Everything will depend on how the company is organized, what processes were identified, if there are similar processes, etc. In this step, it is better to be as meticulous as possible and try to simplify the management of the company, and not fill it with unnecessary procedures.
Step 2: Gather those involved in the processes
Meet with the process stakeholders and draft how they carry out the process activities. Write down every detail, it is only an initial draft, the more information you collect, the more accurate your procedure will be.
Step 3: Create a standard operating procedure template
Depending on the type of organization, the parts of a procedure may vary. But generally the following are used:
Header: Although the ISO 9001 Standard does not require a coding for the procedures, it is advisable to do so for reasons of document organization as it facilitates their search and updating. The heading must go on each page of the procedure, usually it is made as a box where the company logo is placed on the left side, in the central part the procedure code with its name and on the right the date on which will go into effect, the version number and the number of pages. You can also choose to add the process to which it belongs. In the image you can see a procedure design with all this data but without the box that is commonly seen in traditional procedures.
Cover or title page: On the first page at the bottom should be placed those responsible for the preparation, review (in case the organization has so arranged) and approval of the document with their respective signature and date of completion. Unlike the header, it does not have to be repeated throughout the procedure, just being on the title page is enough. It is also advisable to add the charge of those responsible.
Index or Table of Contents: On the second page, it is suggested that it contain the index or a table of contents to allow you to see all the content and have a quick location of the material within the procedure.