SMED in Pharma - A Lean Approach

Navdeep Singh Kathuria is a seasoned business leader with over 24 years of extensive experience in solid oral formulations. He currently serves as the Senior General Manager of Packing at Aurobindo Pharma Ltd. Holding a Bachelor of Pharmacy, he began his career in tablet manufacturing. Throughout his tenure, Navdeep has focused on the standardization of Lean principles within pharmaceutical operations, consistently optimizing productivity while maintaining a strong commitment to quality.

Over a decade, changeover for equipment has garnered a close level of attention as a crucial challenge in the pharmaceutical industry. It further becomes a challenging task when multiple pieces of equipment have to be handled and cleaned within a defined timeline within standard specifications and a set of procedures.  The complexity of processes and relatively longer change over time in pharma is not an unknown reality! A businessman expects regulatory compliance with profitability and any new concept implementation within a budgeted amount to obtain a win-win situation. Balancing all these three aspects is a big challenge and for this, a strong framework and a defined strategy are required within the compliance mode.

As a major part of available time gets consumed in the major cleanup of the production line, only 20-30% of the remaining time is left with the operational activities which forces the businessman to think over the necessity to implement some methodology to optimize the change over time and increase operational efficiency keeping regulatory norms also in place and a then, word Lean comes into everyone’s mind!

Also, being a crucial part of Production procedures, dereliction or careless approach in changeover can attract a major concern regarding the quality aspects, that is, variations in results of analysis and can raise a question on the validity of cleaning methods and inadequate procedures of the organization. Because of that only, change-overs are meticulously planned and integrated into work order planning as a critical process where each minute spent on changeover represents an availability loss in Overall Equipment Effectiveness (OEE). Therefore, it becomes a necessity to optimize the change over time efficiently with all possible efforts.

If we broadly consider the different steps of the changeover process, it involves cleaning, changing the dies (the parts that shape the tablets), assembling parts, setting/ fine adjustments, and qualifying the equipment/set of equipment for each product.

Before the Pharmaceutical industry came ahead strategically to find out the new techniques to optimize the changeover times, Toyota already had started working in the 1950s on Lean principles and came up with a structured approach to improving change over time of their presses which they named Quick Die Change or QDC, resulting in reducing change over times from multiple hours to a couple of minutes in 1960s and further reduction to less than 3 minutes in 1970s. From here, the journey started, and other industrial sectors started showing their interest in acquiring lean tools and techniques to deal with.

What is SMED

SMED, as an abbreviation, is more popular, but, in its full form, it’s Single Minute Exchange of Dies, the process of reducing change over or set up time of any equipment.

Who is the Father of SMED – Shigeo or Taiichi?

Experts move in a bit of Conundrum about who discovered Lean, either Shigeo or Taiichi, but if we review the background of junctures the journey of Lean, both equally and significantly contributed to developing this approach in their way. Both were known for their way of implementing this approach, Shigeo was gentle, and relentless in stimulating people to change for the better, while Taiichi was a bit ruthless and a hard man, who didn’t give a choice, and whatever he had instructed, had to be completed anyhow by his team, with the defined results in a shortest period.                            

Lean vs GMP - Complexity and solution

GMP and Lean, both are anticipated as conflicting principles to each other but understanding or representing both as equal partners can define the importance of both the concepts independently. GMP, as a statutory requirement, is focussed on the systematic approach towards Quality aspects ensuring the medication delivery to the customer with highest standards while prime functionality of Lean is quality along with reducing cost by means of elimination of waste.

Another aspect is that the GMP environment of a health industry is burdened with a flow of standard validated procedures and documentation approval from regulatory authorities which consumes unexpectedly higher timelines and any deviation from the qualified timeslots leads to the non-compliance, filing deviation and investigation compared to the lean where any individual can start up with generation of a single idea, the feasibility of which can be evaluated together with cross functional team and can be implemented immediately. Lean organisation makes an effort to regularly identify and eliminate waste and recognize employee contributions by continuous process improvement, enabling increased flexibility and competitiveness. To overcome such overlapping, Regulatory Affairs, QA and Production need to work parallelly in a balancing way, on the identified improvement projects to support Lean approach without deviating from Quality parameters.

About GMP

After the Sulphanilamide tragedy in US in 1937, killing more than 100 patients due to excipient, Ethylene glycol, US congress passed the first Drug and Cosmetic act in 1938 which leads to the creation of FDA.

After a considerable period, the first text on GMP was prepared in 1967  by a group of consultants of the  World  Health Organisation  (WHO)  and was accepted by the Twenty-first  World  Health  Assembly under the title Draft Requirements for  Good  Manufacturing  Practices in the manufacture and quality control of medicines and pharmaceutical specialties.

Considerable developments in GMP took place in the next decades, and important national and international documents, including new revisions, appeared to comply with the global standards with the prime agenda of the safety of the patient. GMP has been representing a complex system of requirements and institutionalized tradition of pharmaceutical manufacturing for decades.  Therefore, it can be considered as a key reason that compared to other manufacturing sectors, the pharmaceutical industry accepted lean principles very slowly as lean concepts were seen only as a prime motive of cost saving.

Due to the apparent success of lean in the general manufacturing sector, a growing number of players of the pharmaceutical industry have also decided to implement lean  so that  they can  accomplish  their strategic goals such as decrease wait time to release a product to the market, reduce production waste, improve  communication  with  patients  and  increase  quality  level  in production  and  testing laboratories.  Therefore, for pharmaceutical and medical device manufacturers, lean manufacturing represents the way for significant improvement of quality and operational efficiency.

The challenge for them in turning to lean is that all new operational procedures must be compliant with the requirements of GMP and support continuous improvement.  (While lean primarily focuses on continuous improvement and value creation, GMP focuses on ensuring safety, reliability and quality of the drug product)

Therefore, in pharmaceutical manufacturing, the methods of lean management must be harmonized with the standards of GMP by adopting below key themes of SMED:

Measure current change over time, Group internal and external elements, convert internal elements into the external and Rationalize internal and external setup. First, let us understand the internal and external elements

Elements that must be completed while the machine is stopped, is internal and the element that can be completed while the equipment is running is called external one.

The implementation process of SMED was divided into seven stages like Identifying the areas or processes required to minimize changeover, analyzing the changeover time, analyzing all actions performed during the format change, Divide the changeover time into internal and external actions, Optimize the internal phase of tool change (use parallelization), Optimize the external phase of tool change (use parallelization), Review the procedure and build up Action plans and Standardize the procedure, finalize with quick implementation

Some of the challenges that are generally noted while adopting SMED tools on the floor include long changeover times, Unnecessary/long / repeated movements made by the operator and material handler, Lack of space in the shop floor, Disorganisation of equipment (during the changeover), Versatility in cleaning methods among the areas (used chemicals, tools), Versatility in contact times of using chemicals 

To solve these problems effectively, SMED can be monitored effectively with the tools of activity cards (with parallelization), new standards, tool kits (with photo illustration), kanban cards (Weighing and measuring area), 5S (different places).

In conclusion, the overlapping of GMP aspects and the Lean approach exist in every Pharmaceutical Formulation unit at more or less frequency which results in difficulty in acceptance of lean methods because of lack of a complete understanding and unawareness. Senior hierarchy in Production and Quality Assurance needs to work together to spread the understanding of Lean without deviating from the Quality standards. Wherever any lean concept is understood as a hindrance to the implementation of the Quality matrix on the floor, a joint discussion can help to sort out such issues instead of rejecting a new idea in the name of Quality hindrance.