Writing Effective Procedure (QSP, SOP)
One of the main intent of implementation of quality management systems worldwide is to bring in common understanding and development through uniformity of vocabulary relating to businesses or processes so that there is no ambiguity in understanding. Another intent is to make the activities person-independent so that if someone is absent for some reason, another person could work with the help of written procedures and guidelines. These necessitate the creation of written procedures (e.g. Standard Operating Procedure-SOP, Quality System Procedure-QSP, Work Instrcutions-WI etc.), and/or guidelines that are easy to understand, grammatically correct, as well as technically complete in all respects.
Here we will discuss what all needs to be there in a procedure or instruction, and how to write these. The idea is to share my own view for understanding what needs to be written in a procedure. This works well for all such documents whether related to ISO 9001, ISO 13485, CE, GMP, any other standard or anything internal.
A. Contents of a Procedure:
1. Subject: The heading that tells what this document is (e.g. Quality System Procedure-QSP, Standard Operating Procedure-SOP,Work Instruction-WI, Specification etc.), and which process is it related to (e.g. QC, Marketing, Purchase, Production, etc.)
2. Scope: Which activity it relates to and what all it covers
- Who is authorized to use this procedure
- Who is responsible for execution of this activity
- Who is accountable for the execution and outcome of this activity
4. Procedure: It should have:
- What is to be done
- How is it to be done
- Details of the reference standard or instructions to follow a standard
- What equipments, instruments and materials are to be used
- Who will do it
- Where will he do it
- What work conditions need to be there
- When will he do it
- And importantly, WHY he will do it
- Formats where the process/activity data is to be recorded - Who will record it, and who will verify it
5. List of related documents for cross reference e.g related procedures and reference standard or regulatory documents
6. Vocabulary of abbreviations used in the procedure/document
7. Validity period of the document:
- Effective date of implementation of document
- Document expiry or review date
8. Authority and responsibility of documentation:
- Who creates this procedure/document
- Who reviews this document for adequate and accuracy
- Who authorizes the use of this procedure/document
B. How to Write the Procedure Effectively :
There is no standard or single methodology for writing any procedure. It is need based, hence dynamic. However, there are some guidelines that need to be taken care of to create a complete and effective operating procedure:
1. Focus on Intended Executive/User/Target Audience: First and foremast, keep in mind who is the executive/user or target audience of the procedure being created. Consider the factors like their age, qualification, language, skill, experience and work culture etc.
2. Use User's Language: Use the language that is known to the executive/user or intended audience. Generally companies create documents in English, which is not necessary. After all the purpose is to communicate effectively, not to 'communicate-in-a-particular-language' only. Making documents in vernacular language is very well acceptable if that works well for the organization.
3. Make it Easy and Understandable:
- Use simple words and short sentences as much as possible. A procedure is not something to demonstrate language proficiency or oratory skills. Writing short sentences using simple words is always good and advisable.
- Use diagrams and photographs as much as possible and necessary.
4. Write Comprehensively: The one who is writing the document must include each and every required detail necessary to perform a task. It should be written in a manner as if no other person knows about this activity, and needs to be carried-through from beginning till the end like a layman.
It is suggested to create a detailed flowchart of the entire process before starting to write the descriptive procedure. The flowchart represents the activity at a glance and it is easy to find the errors/gaps in it.
5. Be Concise: Avoid writing anything and everything that is not related/required. At the same time do not miss anything and everything that is critical for a given process. There are a few tips to achieve this:
- Write procedure specific to one activity
- Avoid mixing so many activities in one procedure, to the extent possible
- The executive/user must be involved in creating the procedure
- Someone technically proficient must review it during the process for creation
- The draft of SOP must be verified by comparing with actual practice by different executives/users of the same process
6. Include WHY: Usefulness of any procedure is largely dependent upon the understanding of executive/user about their relevance. If executive/user knows the importance of the steps he is following, he is less likely to make an error. Therefore, while writing a procedure, the reason behind an activity must be written, where applicable and required. The procedure must also be explained through trainings for effective implementation.