5S – Lean Manufacturing or Good Manufacturing..??

Any generic industry thrives on defects reduction, increasing productivity, quality improvement, cost reduction, continual improvement etc. There are various principles or methods available, which helps to achieve our aim of Lean Manufacturing Procedures and Good Manufacturing Practices.

We all know a lot about Good Manufacturing Practices popularly known as GMPs. But what about Lean Manufacturing?

Lean Manufacturing is a methodology that focuses on minimizing waste within manufacturing systems while simultaneously maximizing productivity. Waste is seen as anything that customers do not believe adds value and are not willing to pay for.

We have already discussed in detail about waste identification, categorization and reduction in our previous blog “Waste Management in Pharma – Manufacture Lean and Make it a Routine”. In This article we shall be discussing about 5S which is a waste reduction tool and also how lean manufacturing principles go hand in hand with Good Manufacturing.

5S is a lean manufacturing methodology adopted in a workplace and is derived from Japanese words – Seiri, Seiton, Seiso, Seiketsu, and Shitsuke. It is a visual management tool that can reduce wastage leading to increase in the productivity and bottom line of an organization. 5S sets out the key practices which when followed can lead to development of a quality work environment. Following are the English version of the Japanese words along with there meaning:

Japanese Word	English Version	Meaning
Seiri	Sort	Organize
Seiton	Set in order	Orderliness
Seiso	Shine	Cleanliness
Seiketsu	Standardize	Systematize
Shitsuke	Sustain	Maintain

The 5S system was originated in Japan. It was first implemented by Toyota Motor Corporation to organize their departments. This methodology helps in easy detection of non conformances and makes it easy to eliminate them. 5S methodology must be followed in steps in order to attain the desired outcome. This is a continuous cycle and should be maintained in order to obtain the maximum benefit from it.

1. Seiri / Sort

This is the first step in which sorting of the materials, tools, instructions, equipment’s, parts etc. are done and the items not required (for e.g.- items that are defective, obsolete, duplicate, not operation related) are separated from the essential items (periodically used, part of process). A Red tag can be used to tag unknown items. This can help in freeing space in the workplace and orderliness of the process can start to shape up after the sorting step. The people working at that specific place are the best judge about the usefulness of the item. After sorting, the material can either be discarded, recycled, stored, or relocated to a different area. Sorting can prevent inventory waste.

This is similar to GMP requirement of removing defective, out of order and broken equipment from the premises. Also, various examples of sorting in GMP environment are sorting of approved material from under test material, cleaned equipment from uncleaned equipment, good tablet from bad tablet with defects etc.

2. Seiton / Set in order

Set in order is the step where materials are organized at designated places so that it can be reached out with ease when needed. Materials are organized by keeping similar items together, labelling is done and items not required are discarded. Items are placed in the best visible location according to there prevalence of use. Most logical arrangement should be followed so that it could be easily determined by others. This helps in reducing time, inventory and motion wastage.

As per GMP requirement, each item shall be labelled properly and shall be placed properly at their designated places.

3. Seiso / Shine

The materials are brought back to there almost new look by cleaning them from dust and stains. The person responsible for cleaning should be defined clearly and the cleaning equipment’s used should be given designated areas so that they can be easily located. Cleaning should be made a routine task and should include mopping, dusting, sweeping, wiping, putting tools back in order etc. Regular maintenance of equipment is also included in the Shine step. All these can lead to early detection of defects and can prevent sudden equipment breakdown which in turn can lead to reduction in defect and time wastage. Clean area also creates a positive impression to the customers which can help in the business point of view.

As per GMP, cleaning holds prime importance. Cleaning is not done only for aesthetic appearance but most importantly to avoid contamination, cross-contamination and mix-up on shop floor. As per GMP, Cleaning validation is must.

4. Seiketsu / Standardize

Standards are documented sets to consistently organize the working area so that it can be repeated the same way every time which can gradually be incorporated as a habit in the employees. When everything is available timely and at right place, then it can lead to reduction of defect, motion and waiting wastage. Documented reference should be maintained so that the materials can be kept back at the same spot every time it is has been taken out. Standards can include lists, labels, checklists, charts, instructions, schedules, etc. and should be made a part of the routine.

As part of GMP, labels, checklists, SOP’s are desired so that they can clearly specify the status and location of anything and everything.

5. Shitsuke / Sustain

This is the most important and difficult part of the 5S. Maintaining and reviewal of the laid standards are necessary so that the organization do not get back to its old working habit otherwise the whole 5S methodology followed would be of no use. Sustain should be made a part of the work culture then only can it be fruitful for the organization. Everyone should be trained and held responsible for maintaining a clean workplace. Regular audits are necessary to keep a check of the system. Commitment should be maintained to sustain 5S.

As a part of GMP also, it is highly expected that all the procedures, checklists, guidelines established in a plant are regularly followed with utmost precision and dedication.

Besides the aforesaid 5S program, an additional ‘Sixth S’ has been included my many organizations, and that is ‘Safety’. This step is to ensure a safe working environment free from hazards. A safe environment is maintained to keep the employees and products safe. Ergonomics at workstations is an important factor. It ensures that the employees are comfortable while performing their work. Other safety procedures followed are labelling of inflammable reagents, specialised protective gears for designated areas, markings on the floor to differentiate the path of the pedestrians and forklifts in the warehouse, assigning assembly areas etc.

5S methodology has several benefits when implemented properly. Few of them are as follows:

• Reduces rate of defects
• Safe workplace
• Increased production
• Better resource utilization
• Reduction in equipment downtime
• Less wastage
• Improved quality
• Higher availability of equipment’s
• Reduction in cost
• Increased employee morale
• Improvement in work environment
• Enhanced portrayal of the organization in front of customers, stakeholders, and suppliers
• Can lead to Continual improvement
• Increased profit

Adopting 5S can gain popularity to an organization and can boost business. It is versatile and can be adopted in every type and size of organization.