Shruti Bhat PhD, MBA, Lean Six Sigma Black Belt
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Just-in-time methodology applied to life science research and development division to improve R&D operating efficiency- A case study

7/19/2020

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Just-in-time is one of many time-tested, scientific business improvement methodologies and can be successfully applied to any industry be it manufacturing, services, government office or an education institute.
Just_in_time methodology applied to life science research and development division to improve RandD operating efficiency_ a case study by Dr Shruti Bhat
Just-in-time (JIT) technique is usually applied to manufacturing and service functions of companies, but not to their R&D divisions. 

​
Considering the vast benefits of JIT methodology, I recommended using it in R&D division of a Life science company (my client). This company had a major set back; consequently, had a severe cash-crunch and was looking for a better option to sustain business and avoid employee layoffs.

This project was accomplished few years ago. However, the learnings are relevant today perhaps more than ever before.
The reason being that the Covid-19 pandemic has created a funds-crunch in companies big and small; though start-ups, small and mid-size organizations bear more brunt. Innovation portfolios are being driven in the slow lane, R&D budgets are getting axed and yet the divisions must do more with 'still' less.
​
In such a scenario, applying Just-in-time in combination with strategic vendor management will facilitate companies to tide thru this funds-crunch and parallelly continue their R&D endeavor of developing new products.
R&D departments of pharmaceuticals, vitamins & supplements, natural health products, cosmetics and personal product companies need a very large quantity of consumable items. Some of the consumable items are- raw materials, packing material, tools, machine spares etc.

Some of commonly used raw materials in life science R&Ds include- Active ingredients (such as bulk drug, herbal extract), additives (such as bulking agents, colors, flavors, perfumes, emulsifiers, solvents etc.), packing materials (such as tubes, bottles, caps, wads, aluminum foil, paper, glue), machine parts (viz. tablet punches, dies, chromatography columns).

These consumable items are extensively used during experimentation for new product development and testing. In fact, the R&D department cannot function at all if consumables are not provided.

In research-based life science companies and contract research organizations, consumables comprise of 20 – 45 % of their R&D budget. Therefore, any savings in consumable expenses help organizations to lower over-head costs big-time, and Just-in-time methodology does just that!

A four-step approach was taken for this project-

Step 1: The existing supply chain process was mapped, inventory demand-supply schedules reviewed and gaps in these processes were identified.

The objective was to re-design the supply chain process to include Just-in-time technique to lower R&D over-heads (without disturbing R&D output) and the savings generated thereof could be utilized for other needs of the business.

Step 2:  A supply chain process improvement strategy was designed.

Note that, there are several dos and don’ts prior to applying Just-in-time technique for process improvement or process design. One of such important to-dos, is to ensure all items being sourced comply to CQA (Critical Quality Attributes).

Step 3:  A core team comprising heads of R&D, Manufacturing, Quality, Regulatory and Procurement was formed.

Then all consumable raw materials were classified into- expensive, moderate and cheap items, based on their cost and availability. Vendors were approached to provide samples (of raw materials) for testing. Once test results proved compliance to CQA, the vendors were short-listed.

Step 4:  Just-in-time process was set up.

This also involved effective collaboration between R&D, resource planning and quality groups. Then, meetings were conducted with vendors to provide raw materials at negotiated price to R&D. Vendors for expensive raw materials were approached first, followed by those for moderate and cheaper items.

Note that-
  • Depending on the size of the organization and the number of consumable items to be worked on, it might take from 2 to 8 weeks to fully set up Just-in-time in a company.
  • Just-in-time methodology encourages sourcing from local or regional vendors rather than overseas. Should a company go for an overseas vendor, then make sure that vendor has a distribution warehouse situated locally or regionally.
  • Savings from Just-in-time implementation are further augmented when R&D's follow Quality-by-Design (QbD) approach for product development.

Result Dashboard: 
  1. Through flawless execution of Just-in-time technique, around 35% of R&D over-head cost was saved in the first year.
  2. Besides lowering over-heads, Just-in-time also helped free-up warehouse capacities.
  3. Continued implementation of Just-in-time technique maximized over-head savings up to around 80%.
To know more on how Just-in-time technique can benefit your organization-
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You may want to checkout more on Just-in-time:
  • What is Just-In-Time approach?
  • Advantages of Just-in-time strategy
  • Just- In-Time Production Strategy with mastermind Shruti Bhat : Limitations
Keywords and Tags:

​#JustInTime  #ImproveOperatingEfficiency  #ContinueInnovation #ContinueProductDevelopmentInPandemic   #Covid19  #ImproveOperatingExcellence  #ProcessImprovement  #ProcessDesign
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Business Turnaround Of A Sick Contract Research Company- A Continuous Improvement Case Study

3/3/2020

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​Practising 'Daily Kaizen' has brought about swift turnaround of the sick contract research organization (CRO). Learn how Japanese Kaizen principle was used to speed-up Generic Pharmaceutical Product Development in a contract research company in Asia.

Watch on...
To learn more about how Shruti can help your organization achieve new heights or to book a Workshop, Contact Dr. Shruti Bhat via Form or WhatsApp

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Keywords and Tags:
​
#Manufacturing #Lean #ContinuousImprovement #Kaizen  #QualityImprovement  #ManufacturingManagement  #LeanInnovation  #Pharmaceutical  #LifeSciences  #Drugs #KaizenLeaderMasterclass  #Kanban  #ProductDevelopment #BusinessTurnaround  #BusinessTransformationofaCRO
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Lean Manufacturing in Food, Drug, Cosmetics & Chemical Industry

2/25/2020

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Here is a case study that exemplifies ​improved productivity of pellet manufacturing by 28% per shift via LEAN. 
Learn about how to use LEAN Business Process Improvement methodology for
​Innovation and Manufacturing …
To learn more about how Shruti can help your organization achieve new heights or to book a Workshop, Contact Dr. Shruti Bhat via Form or WhatsApp

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Keywords and Tags:

​#Manufacturing #Lean #ContinuousImprovement #Kaizen  #QualityImprovement  #ManufacturingManagement  #Pharmaceutical  #LifeSciences  #Food  #Beverage  #Biotechnology  #LeanManagement 
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Continuous Improvement for Human Resources (HR) department via Lean and Kaizen

2/19/2020

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​Have you ever been in a situation where there are open positions in your department that haven’t been filled out for one or two years?

On one hand there is mounting workload while on the other hand the response from HR office is that, they are and have been doing their best- they have personally looked out for good candidates, contacted several recruitment companies to get biodata of suitable candidates, yet they haven’t been able to find a correct fit for the open roles.

Many a times supervisors and department heads term such HR responses as ‘excuse’. 
Workshop on Lean Manufacturing, 30 lean ways to improving manufacturing productivity reduce overheads an skyrocket profits, business process management and continuous improvement executive guide series book, shruti bhat, lean enterprise, lean management, lean startup, house of lean, house of quality, workshops on lean, webinars on lean
But believe me this is absolutely possible. Despite genuine efforts, recruitment goals are unmet in big and small companies. Recruitment gets more complicated when knowledge workers and people with special skill sets or registration needs are being sought.

Although one can’t completely discount out that there might be a chance where up-to-date efforts may not have been put in by those involved in the recruiting process, but usually HR guys are genuine with their responses. Positions remain unfilled for long times, HR tries hard on their bit, while the department which owns those open positions burn mid night oil by asking existing employees to work overtime to meet quarterly work targets. 
If you have such situations in your organizations then your company needs bigtime process improvement in its HR function!
Process improvements in HR departments can impact recruitment goals in many ways.

Let me give you a short case study- Few years ago, I was hired by a Canadian company which dealt with recruitment challenges similar to the ones stated above. Post situational analysis, I recommended them to improve the recruitment process via a combination of Kaizen and Lean Continuous Improvement techniques. We designed a strategic process improvement plan for their recruitment process.

The picture below is self explanatory.
Lean for service industry, business process management and continuous improvement executive guide series book, shruti bhat, lean enterprise, lean management, lean startup, house of lean, house of quality, workshops on lean, webinars on lean
As you will notice, the process improvement exercise speeded-up filling up of open positions that were stagnating for over 2 years. Process improvement also saved advertising costs, decreased candidate screening time which in turn translated into improved HR productivity. By fifth month of initiating the process change campaign, 18 out of 21 open positions (lying open for over two years) were filled up!
​
Another place for HR process improvement is- Avoiding ‘firing’ employees by ‘right hiring’.

No one likes to fire employees, even if that person is truly lousy at whatever they do and makes everyone else around them miserable. Much has been written on ways to fire kindly, diplomatically etc., but what is discussed less is- ‘how to avoid (improper) hiring in the first place’.

Almost on autopilot, most HR departments post new job offerings and begin the process of filling a position as soon as that position’s previous occupant departs.

An employee’s departure must be used as an introspection to re-evaluate that role from several perspectives, for example- Do we even need this role? Can we reduce this full-time role to part-time or switch to a contractor or outside vendor? Do we need someone with a different skill set? Is there someone within the organization who can be trained and relocated to a new position? How does this position contribute to achieving our corporate goals for the next three years etc.

And such introspection must be done via strategic design of HR Continuous Improvement plan and its flawless implementation.​

​I recommend Kaizen, Lean, ISO and CMMI (Capability Maturity Model Integration) for Process Improvements in HR function; though, cost-effective and best results are observed with Lean Kaizen.
To learn more about how Shruti can help your organization achieve new heights or to book a Workshop, Contact Dr. Shruti Bhat via Form or WhatsApp

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Keywords and Tags:

​​#Kaizen  #HR #ProcessExcellence  #ContinuousImprovement   #BusinessProcessManagement  #ServiceIndustry    #BPM #LeanManagement  #KaizenLeaderMasterclass  #kaizenInHR
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How to Manage Inventories, Cut Wastages and Rejects in Warehouses? A Lean Six Sigma Case Study

2/12/2020

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how to manage inventories cut wastages and rejects in warehouses _ a lean six sigma case study
​Lean Six Sigma case study in a pharmaceutical company

Problem: A Canadian Drug company had huge inventory and also wastages in their warehouse. How to cut down rejects? Is there a scope of reducing procurement expense?

Due Diligence :  The procurement process was mapped and it was found that the inventory management process was inefficient. Multiple investigative tools were employed to arrive at root cause(s) of the problem.

Solution: Lean six sigma methodology was employed. A new inventory management process was designed and integrated with SAP- ERP system. A ‘FIFO’ usage and distribution system was introduced and implemented across all locations within the organization.

Roles and responsibilities for continuous implementation of the new inventory management process was assigned to department members. Appropriate training was provided as well as documented.

Result Dashboard:
  • Decreased % rejects by 200 %
  • Decreased materials procurement by 150 %
  • Improved supplier relationship.
  • Smoother supply chain logistics process
  • Improved cross-functional team engagement, in turn better productivity.
To learn more about how Shruti can help your organization achieve new heights or to book a Workshop, Contact Dr. Shruti Bhat via Form or WhatsApp
​
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Keywords and Tags:
#ContinuousImprovement   #Innovation  #LeanSixSigma
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Lean Innovation, Hoshin Kanrii and Six Sigma (as DFSS) for Product Design, Development and Manufacture via 3D Printing; a Case Study

2/5/2020

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Lean Innovation, Hoshin Kanrii and Six Sigma (DFSS- design for six sigma) for product design, development and manufacture via 3D Printing (i.e. Additive Manufacturing) Case Study by Dr. Shruti Bhat, gives benefits of applying Hoshin Kanrii, DFSS and Lean Innovation techniques to a drug product design, development and manufacture via 3D Printing.

The study findings however can be extended to product development across other industry verticals.


Some of the benefits of applying continuous improvement methodologies such as Lean, Hoshin Kanrii and Six Sigma to research and product development include-
​
  1. Application of Hoshin Kanrii and DFSS along with Quality-by-Design (QbD) to product development usually brings novelty in product features, process characteristics and/or product utility, thus favors patenting and generation of additional revenues.
  2. While, Lean Innovation creates products with effective and efficient production and packaging processes, with no scope for ‘rework’ thus, better Operations Management.

​The study uses Isosorbide dinitrate (ISDN) as model drug, although other drugs can also be used in this therapeutic platform.

2x3 Factorial Design of Experimentation (DOE) was used to design drug beads. The results were evaluated for regression analysis, Main and interaction effects of parameters, Contrast Column Dispersion effects, Normal Probability Plots, Pareto and Process Capability Analysis.

The drug beads were further used as ‘starter’ seeds to develop MUPS (multi-unit particulate system) anti-angina ‘rate-programmed’ drug product.

The pharmacokinetic- pharmacodynamic (PK-PD) modeling was done using Doebrinska- Welling equation. MUPS were developed using 3D Printing technology via a 12- Run Plackett Burman DOE.

All hardware, software applications involved in the study were pre-validated. All qualifications i.e. Design Qualification (DQ), Installation Qualification (IQ),  Operational Qualification (OQ), Performance Qualification (PQ) for each experimental run was done as per USFDA guidelines. Data was analysed statistically using Paired ‘t’ test. Reliability Testing was conducted as per ICH current Good Clinical Practices (cGCP) guidelines.

Product prototype and Reference listed drug (RLD) were compared for bioequivalence compliance. The prototype is ready for commercialization.

This study also gives benefits of using 3D Printing technique for pharmaceuticals and how the technique can be applied to product development across other industry verticals!
​

For details on how to apply Lean Innovation, Hoshin Kanrii and DFSS to product design, development and manufacture, watch the video …
To learn more about how Shruti can help your organization achieve new heights or to book a Workshop, Contact Dr. Shruti Bhat via Form or WhatsApp

Recommended reading:​

  1. Workshops & Online Courses for Pharmaceutical Research and Drug Product Development by Dr. Shruti Bhat
  2. Kaizen for Cost-Savings and Organizational Excellence
  3. Mistake-Proofing Pharmaceutical Products: What can we learn from Valsartan, Losartan and Irbesartan recalls?
  4. How to develop a culture of ‘Continuous Improvement’ in an organization?
  5. ​Innovation is not an initiative. It’s a business process !​
​Follow Shruti on Twitter, Facebook, YouTube, LinkedIn


​​Keywords and Tags:
#ContinuousImprovement   #Innovation  #Lean  #HoshinKanri  #DFSS  #DesignForSixSigma
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How to Reduce Testing Load of Analytical Labs in R&Ds? A Six Sigma Case Study in a Biotech Company

1/22/2020

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how to reduce testing load of analytical labs in research and development _ a six sigma case study in a biotech company
Six Sigma Case Study in a Biotech company

Problem: A Canadian Biotech company had too many samples for testing in their research lab. How to cut down this analysis load?

Due Diligence:  The entire product development process was mapped end-to-end. Possible causes for the problem were identified using RCA. It was found that, there were way too many experiments conducted during product development. For e.g. 85 experiments were conducted to arrive at a base level prototype having minimal features.
 
Solution: Six Sigma methodology was employed. More of experiment planning was needed during product development. Regardless of type of product or product complexities, the aim was to keep experiments to minimal. Design Thinking and DOE were employed. The development protocol was modified such that final prototype is developed with meager 20 experiments at the maximum. Alongside cutting down analysis load, the process improvement campaign cut down product development time, built-in product quality, and enhanced production output.

Result Dashboard: 
  • Decreased overall development costs by 200 %
  • Improved R&D’s productivity by 250 %
  • Prevented recruitment of additional scientific manpower, thereby curtailing business    expenses and overheads.
To learn more about how Shruti can help your organization achieve new heights or to book a Workshop, Contact Dr. Shruti Bhat via Form or WhatsApp

Follow Shruti on Twitter, Facebook, YouTube, LinkedIn
​

​​Keywords and Tags:
#ContinuousImprovement #Innovation  #SixSigma  #DesignThinking  #DOE  #Biotech
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