What is it: A Standard Operating Procedure (SOP) defines the key processes of the business and identifies who is responsible for various aspects of their implementation. They identify “What” is to be done and “When”, while referencing to level documents as applicable. An SOP is an agreed description of a stage or part of a process, which gives sufficient information for an existing or new staff member to understand what steps must be carried out, what inputs or supporting documents are required, and what outputs should be produced. The SOP is the third layer of documentation in a Quality Manufacturing System (QMS) as shown below:
Why use it: The benefits of Standardised Operating Procedures is that clear step by step major desisions are written down in a standardised concise wording where all employees have a clear understanding on tasks that are required to be carried out and by whom. The features of standardising includes safe systems of work, quality assurance and control, the movement of employee process elements to organisational documented process elements, providing the benchmark or baseline for all future improvement. The use of SOP's are a standardised work approach and is a disciplined approach, an essential foundation for lean manufacturing.
Well written SOP's provide:
The SOP development process is an excellent way for managers, workers, and technical advisers to cooperate for everyone’s benefit. Even if your company is not seeking official ISO 9000 certification, SOP's can still provide the same benefits - because your people will be doing their work "the standard way" that is thoroughly documented and audited - so that your customers and investors can trust that your processes are under control - and more importantly, so that you can trust that your processes are under control.
Where to use it: A SOP will define the most efficient methods to produce product using available equipment, people, and material. SOP's depicts the key process points, operator procedures, production sequence, safety issues, and quality checks.
When to use it: An SOP will be used when work affects more than one function or department of an organization, the procedure will highlight who is responsible and what steps that must be taken to carry out the process.
How to use it: A typical SOP contains the following elements: A Header which shows the Title of the SOP, Original Issue Date, Revision/Review Date, number of pages contained in the SOP, who wrote the SOP, and the Approval Signature. Usable example of a SOP Header in MS Word.
Each system SOP is viewed as the "parent" document, which may have any number of "offspring", or "Work Instructions", which are created only when and where there is a need for more detail. Nn Work instruction is an orphan. Each can be linked back to it's "parent" S.O.P. In general, SOPs force a person to think through a procedure step by step and to standardize the materials and methods. The exercise of writing the SOP is valuable and the SOP itself is a useful training tool and a reminder to staff of the correct procedures. The best approach to writing an SOP is to do it, write it, and test it. Be brief and succinct; the shorter, the better. Anyone - student, support staff, post-doc or principal investigator, can prepare them. The SOPs should be readily available.
The work procedures are usually completed by committed cross functional work teams and encourages contribution of experience, knowledge, accuracy and ideas for constant improvement.
Contents of template package: 1 * ISO Standard Operating Procedure Template Package (Containing the following procedures in a Microsoft Word document)