What indicates the expiry of an SOP Document?

SOPs or Standard Operating Procedures, as per the WHO, are written manuals that mention, in detail, how a particular procedure like a test or administrative process needs to be performed. SOPs are also relevant to operate machines and equipment, their maintenance, and calibration. These are standard-approved procedures. The Standard Operating Procedures development process should involve people who work at the ground level, and people who can bring a unique perspective and value-addition to the process.

While a SOP documents every last detail of the procedure, there needs to be a proper ‘change control’ mechanism to keep track.

Just like every other thing, SOPs or Standard Operating Procedures come with an expiry term period. While preparing such a document, it is critical for everyone across the team – department heads, technical authority, QA, and QC managers to understand and agree at what point the SOP has reached its useful life or is due for a revision.

The Quality Assurance (QA) or Internal Audit team is responsible for revising the SOPs though the actual Standard Operating Procedures development process should involve people who work at the ground level. The team needs to review the document and lookout for indicators that translate into the document’s end.

Sometimes, the actual process or procedure changes beyond the original SOP scope, or the process or procedures mentioned in the SOP becomes redundant and outdated. Such situations trigger a revision or redrafting of the SOP. When the SOP fails to live up to the actual procedure or does not produce optimized results, the SOP requires a review and revision. While many industrial domains have a formalized process to identify the end date, many businesses need to monitor and review the SOPs on a regular basis and keep a watch over changing conditions. These changing conditions indicate the need to revise the SOPs, by either new Standard Operating Procedures or by amending the existing ones.

What are the possible issues and problems if SOPs are not revised?

An SOP intends to help reach from point A to point B in a process effectively while ensuring proper controls. To think that the SOP is working perfectly for your business and sit back with your feet up never works. Having blind faith in the SOP can be catastrophic. It is important to keep reviewing the SOP occasionally. When a man is not immortal, expecting processes, technology, etc., to be immortal is not wise. Following redundant or inaccurate procedures can lead to failures.

Here are six indicators that are a sure-shot way of understanding that it is time to relook at the SOP and go in for a revision:.

• When quality control of processes and products are not happening as desired
  Standardization of quality is the fundamental aspect behind Standard Operating Procedure Development. What is most important is that customers today expect brands to deliver consistent and standardized quality products. An SOP document mentions the exact steps that need to be undertaken to perform the process. However, if the products do not offer constant and unswerving quality, one of the reasons could be that the standard procedures mentioned in the SOP are failing somewhere down the line.
• When the procedure is no longer safe
  One important purpose of drawing up an accurate standard operating procedure is to safeguard the health and safety of workers, employees, and also the environment. The SOPs might have been prepared a few years back or at the start-up phase of the unit. At that point in time, the procedure was fine and ensured employee and environmental safety and well-being. But, today, things may have changed, and the procedure is no longer as safe. When failures mark the same manufacturing process, or there is a harmful emission, in such a case, it is time to change the SOP.
• When government laws of compliances and regulations change
  The concept of using Standard Operating Procedures has been there for quite some time now. Organizations that have been there for some time develop the SOP as per the existing laws. However, government rules, regulations and statutory requirements can change anytime. In case such changes have been announced, companies need to go back and study revisit their standard procedures and make sure that the SOP is amended accordingly. The QA or the internal audit department is responsible for the regular audit of the SOP to ensure conformity with government regulations at all times.
• If the production or the manufacturing processes are taking way too long
  SOPs are intended to make processes fast and agile. While initially, it may be working out fine, over a period, if you realize that the process is taking substantially more time than it should, it means that the SOP has something amiss. The audit department needs to act, analyze and revise the entire SOP again swiftly. If The the mentioned standard operating processes are unable to reduce delays, equipment failure, or damages or reduce costs, it strongly indicates that the procedure has some faults and loopholes that need immediate redressal.
• When a process or a piece of machinery gets changed
  Obviously, when there is any change that the organization embraces, they need to revise the SOP. It could be a change in the process, or the machinery/equipment being used. With the advancement in technology, most businesses today move from one technology to another. It can be a complete overhaul of an existing procedure or the purchase of a new machinery to make the work faster and easier. After all, the entire logic of Standard Operating Procedure Development is to facilitate a smooth and precise procedure. Hence, SOP revision becomes inevitable here. The extent of revision or the decision to draft a new SOP will be the decision of the concerned department head, the people involved in executing the procedure, and the QA team.
• When the team’s performance is not as per desired standards
  If the team’s performance is not optimized, the SOP document may require a change. SOPs are used for training and coaching others, be it a new employee joining the team or re-enforce procedures with the team. However, if most team members fail to deliver the expected output and the performance is lacking, goinglacking, going back and reassessing the SOP can be one way to find the reason behind such performance issues. If the same is process-related, even then changes need to be made to the SOP.

CONCLUSION

SOPs are lifelines for most organizational processes and methodologies. They are factual sheets that act as an auditor’s checklist and a reference point to spot deviations. Besides, SOPs offer the right way for the team to work and perform optimally, saving the organization’s cost and time. Therefore, it is imperative to look out for indications, understand ‘when’ and ‘how’ an SOP revision needs to be initiated.