Vittakosh is an outcome of a notion – a belief that we can and ethical practices.
Regardless of their functional specialties, all firms make an effort to provide the highest possible quality goods and services. To keep a competitive advantage and keep their customers happy, this is crucial.
This is where SOP plays a part. We will examine every facet of the subject in this post and determine the value of SOP across various sectors. Therefore, let’s begin.
A pharmaceutical manufacturing plant will normally create, maintain, and follow hundreds of SOPs. This collection of written guidelines outlines a routine or repeated task that staff members in an organization must perform. SOP creation and application are crucial components of a successful quality system. It offers guidance on how to carry out a task correctly and consistently to meet predetermined standards and provide high-quality results.
The following, as well as step-by-step instructions, are included in properly developed Standard Operating Procedures:
One has a variety of organizing and formatting options when creating an SOP. What kind of SOP is used or created depends on a few criteria.
SOPs ought to be prepared in a succinct, sequential, and simple-to-read format. Each SOP should adhere to a common structure. To eliminate any ambiguity regarding what is necessary; information should be communicated plainly and explicitly. It is best to employ the present verb tense and active voice. The procedure should be represented visually with a flowchart.
The purpose of documentation is to guarantee that procedures are carried out in a particular sequence. Any supporting materials that were provided as part of an activity should be cited in the SOP after being attached to it. The batch record file includes all supporting materials employed during the implementation of a procedure.
Within the pharmaceutical industry, the ability to recognize a need and create and manage Standard Operating Procedures is technologically advanced. For deciding which procedures need to be documented, the organization should have a methodology in place. Then, those SOPs should be created by experts who are familiar with the activity and the internal workings of the business. These people are essentially subject-matter specialists who carry out the task or use the technique. A collaborative effort can result in greater outcomes.
An employee who regularly completes the work or a person who is directly in charge of the task’s completion should write the SOPs.
Ideally, teams composed of some or all of the following individuals should write SOPs.
Those who will do the work,
Those who will maintain the related equipment,
Designers of machinery and procedures, such as engineers,
Technical entrepreneur,
Safety officials,
Equipment manufacturers and environmental professionals.
After being put together, the draft SOP should be distributed to the initiators for review before being edited into a final document for review by managers and followed by employee testing under supervision. Most essential, SOPs should be examined by several individuals equipped to judge the SOP’s completeness and subject matter clarity. Someone other than the original author who has the necessary training and procedural experience should give the document its final approval.
Procedures need to be updated every time a change is made to the process for them to stay relevant and beneficial. Reapproval is required for updated processes. Modifications must be recorded in a change control table at the start of an SOP. An exclusive revision number ought to be assigned to each version.
Additionally, SOPs ought to be routinely examined regularly (e.g., once or twice a year) to make sure that the policies and procedures are still relevant and suitable or to decide whether SOPs are even required. Each reviewed SOP should include the review date. The application of quality should be removed from the source folder and preserved if an SOP refers to a procedure that is no longer used.
For improved administration and control of SOPs, don’t forget to include an SOP on SOP formulation, approval, revision, and management. It is essential to effectively handle the administrative components of the SOP system, including distribution and filing. A system owner can help with overall system administration.
A system owner ideally-
Eliminates out-of-date SOPs;
Ensures that SOPs are user-friendly and fulfils their quality requirements;
Controls SOP change management; SOP distribution;
Makes ensuring SOPs are up to date;
Ensures that updated or new SOPs are only effective when training has taken place and offers training on the SOP system;
The performance of the system is measured, and management is notified of the findings regularly.
Procedures do not ensure quality work or successful outcomes; they are not an aim in themselves. A strong business culture, competent staff, and well-designed systems and processes are more crucial. Process, people, and the workplace are all supported by procedures. A good process, a qualified staff, or a productive workplace cannot, however, be created by a technique.
When implementing an SOP or modification, training comes in first. The advantages of following the technique and the risks involved if the protocol is not followed should both be emphasized throughout training. When people are aware of the significance of a method, they are far more likely to follow it.
SOPs are an essential tool for communication at all organizational levels. They give management and staff a cross-functional perspective of the company and empower staff sectionally. This strategy encourages staff to consider how changes in one functional area can impact others. A good system compels staff to consider how actions might affect the final result, the people involved, the output, and the machinery. But remember that if they are not followed, even the best-crafted SOPs will fail.
Our article’s purpose is to make you informed of your obligations and contributions to your business, and you can only do that if you have a thorough awareness of your company’s SOPs and are informed about its operations, quality standards, and ethical standards.
Vittakosh is an outcome of a notion – a belief that we can and ethical practices.