5S IN PHARMA INDUSTRY
A process industry is commonly referred to as a manufacturing process where a chemical change has taken place, and it includes segments such as glass and ceramics, as well as industries associated with the manufacture of chemicals, minerals, coal, metal, and consumables, to name just a few.
The philosophy of 5S is built around the following five terms: –
Sort (Seiri):- Sorting is the first step of 5S. The importance of this concept lies in looking at items (i.e., tools, lubricants, items used for job changes) in the work setting and deciding what is really needed to get the job done efficiently and effectively. If it is essential for the job, it is tagged; if it is not necessary, it should be discarded.
Sorting’s benefits include: –
- a more effective use of space,
- simplified tasks,
- a reduction in hazards, and
- a significant decrease in distracting clutter.
Set in Order (Seiton):– Think of this concept as determining where everything that is needed to do the job should be placed for easy access. Every item needed for the job-every tool, every SOP, even the MSDS manual-must have a home where it can always be found when it is needed. In most process industry job changeovers, the time can be long and changeovers can be frequent. Line downtime (waste) is increased if equipment needed for the job must be found because it is not in its place.
The benefit of Set in Order is that everything needed for the job is clearly visible in a designated location. A good example of this concept is a maintenance shop that has a board on the wall with an outline of every tool that belongs there. Every tool is visible; if it is not in the appropriate spot, the user can recognize the need to take corrective action ahead of time. Therefore, knowing where to look is the first step in the beginning of a standardized process, as pointed out in the Journal of the Institute for Quality Assurance.
Shine (Seiso):- This third concept is based on the fact that the process has now eliminated what is not needed and organized the required tools and equipment for efficient use. As a result, the next step is to keep the work area and process equipment-everything else used to make the product-clean. A dirty production process increases the potential for process variability.
For example, consider dirt getting into a batch or coating process and causing rejects down the line due to “foreign material.” A dirty process often requires more time for changeovers due to cleanup-related issues, with the ultimate result being a loss of production or equipment failure. Again, this lost time is considered waste and non-value-added time. Another issue worth considering is that an unclean area is more susceptible to safety issues that could potentially cause worker injury.
Standardize (Seiketsu):– The focus of this term is to have a standardized process for maintaining the system. One lean industry group maintains that this fourth concept “consists of defining the standards by which personnel must measure and maintain ‘cleanliness.’ [For the work environment], visual management is an important ingredient of SEIKETSU. Color-coding and standardized coloration of surroundings are used for easier visual identification of anomalies in the surroundings. Personnel are trained to detect abnormalities using their five senses and to correct such abnormalities immediately.”
Sustain (Shitsuke):– Most users and research on the implementation of 5S often say this is the most challenging step. It involves making the 5S philosophy a way of life so that the organization can maintain the gains that have been achieved. The concept revolves around practicing the new habits that are being learned. It entails that everyone who is involved feels empowered to maintain order, cleanliness and the standard operating procedures as a normal way of life-as opposed to as a response from an audit finding. As user experience points out, this step “focuses on defining a new status quo and standard of work place.”
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