Let’s imagine a pharmaceutical company is going to hire an employee for the drug production line. This new employee must undergo a lot of training to be able to carry out the activities and assist in the production of batches of homogeneous drugs. Even if the person has experience in this role, a new company means new rules, new equipment, new formulas etc.

So what’s the right way to train the person?

We know that the transfer of knowledge from an older employee to a new one is a flawed way of doing the transfer. In addition to passing on bad habits, there is also the chance of forgetting some essential parts of the process. For training activities, as well as other types of activities, companies rely on standard documents.

What is a Standard Operating Procedure (SOP)?

A standard operating procedure (SOP) is a document that formalizes the tasks in an organization, linking them to the people responsible for them and to the resources used in each stage. In this way, it provides the identification of the data of “who,” “what” and “when” all phases of operations are carried out.

A SOP presents this information in a broad manner and generally using more technical language, according to the terms of legislation and standard norms.

What is a work instruction?

Work instructions (WIs) are elaborated and linked to the SOP. In addition to describing the activities and those responsible for them, these documents provide more details on the tasks, including aspects such as the mode and time of execution. In other words, WIs show “how” activities are carried out.

Based on a user manual, work instructions should use simple language and be written using an uncomplicated step-by-step process with information that is essential to perform the task. Images, photos and tables can be used to further facilitate employee understanding.

What is the difference between a SOP and a WI?

Although they share similar structures, in general, WIs and SOPs have different functions. Especially within the quality management system documentation, the hierarchy of these documents is different. Below is an example of a hierarchy structure:

  • Level 1 = Quality Assurance Manual: Starting point for targets, objectives and responsibility.
  • Level 2 = Procedures (SOPs): Interaction between departments / business units in terms of inputs / outputs.
  • Level 3 = Work Instructions (WIs): Documents that define how the work objectives are achieved.
  • Level 4 = Records: Evidence of compliance.

Thus, WIs are at a level below the procedures and the distinction between these documents is made based on their use and degree of detail. While the first is applied to operational activities and provide a wealth of details, SOPs are responsible for standardizing management processes, with the characteristic of being a system standard.

Both can be applied at all stages of the process and seek to ensure that people do the same task uniformly. With respect to legislation, there is no difference between the two terms.

How to elaborate SOPs and WIs

Regardless of the business area, companies need to have well defined standard documents since they help people to understand how to perform routine tasks safely, in compliance with regulations and consistently, regardless of the person responsible for carrying out the activity.

Although there is no official document with guidelines for preparing these documents, these are some tips that can help you plan an effective standardization model.

  1. List all the activities and processes that will be documented;
  2. Ask employees who participate in the process/activity for help to prepare a highly detailed document that reflects reality;
  3. Observe the activity on-site to gain a basis in reality;
  4. Know the public that will use the documents and use adequate language;
  5. Whenever possible, use tables, flowcharts, images and photos to illustrate and facilitate understanding;
  6. Always update documents and train employees after each new revision;
  7. Use references, mainly in SOPs, when applicable;
  8. Verify if there is any procedure or instruction that needs to quote specific information in rules or legislation;
  9. When necessary, link procedures, processes, work instructions and records to the document;
  10. Ensure documents are easily accessible to the people that need access to them.

An automated solution helps in the preparation, organization, management and control of documents, ensuring that anyone can easily find documents when they need them, and in accordance with the security level of each one of them.

Discover SoftExpert Document, a software solution that allows organizations to effectively and efficiently automate the management of electronic and paper documents over their entire life cycle. Manage and work on your documents securely, at any time and from anywhere.

Camilla Christino

Author

Camilla Christino

Business Analyst at SoftExpert, graduated in Food Engineering at Instituto Mauá de Tecnologia. She has solid experience in the quality area in the food industries with a focus on monitoring and adapting internal and external auditing processes, documentation of the quality management system (ISO 9001, FSSC 22000, ISO / IEC 17025), Quality Control, Regulatory Affairs, GMP, HACCP and Food Chemical Codex (FCC). She is also certified as a leading auditor in the ISO 9001: 2015.

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