Spotlight: Are production bottlenecks, inconsistent quality, or compliance challenges affecting your pharma operations? Here's how we helped a mid-sized North American pharmaceutical company achieve a 25% increase in production output and reduce batch processing times by 30% in just months, using Lean Manufacturing principles.

We uncovered inefficiencies, streamlined workflows, and fostered a culture of continuous improvement, enabling the company to meet demand faster, cut costs, and improve regulatory compliance—all while enhancing product quality. Checkout full story below...

How Lean Manufacturing Transformed a Mid-Sized North American Pharma Company- A Case Study.

A mid-sized North American pharmaceutical company was facing significant challenges in its manufacturing operations. Our audit followed by root cause analysis revealed that the organization was plagued with huge production bottlenecks and inconsistent product quality was common, stemming from inefficient processes. This not only slowed down production but also impacted their ability to meet compliance standards consistently. These issues jeopardized their relationships with clients and added to operational costs, making it essential for the company to seek a solution that would enhance both efficiency and quality.

To address these challenges, we advised the company to adopt Lean Manufacturing principles, aiming to reduce waste and streamline the production workflow. Lean methodology focuses on minimizing non-value-adding activities, improving the flow of operations, and fostering a culture of continuous improvement. The company began by assessing their production processes, identifying areas where waste was prevalent, such as excessive movement of materials, waiting times, and unnecessary steps that contributed to delays. By streamlining workflow and establishing more efficient layouts, in just seven to eight months of commencing the project, we succeeded in eliminating eighty percent of bottlenecks that were slowing down production.

Another crucial aspect of this Lean implementation initiative was to introduce continuous improvement protocols in the organization. This encouraged employees to regularly assess their work processes, identify potential issues, and suggest improvements. Training was provided to ensure that the employees understood Lean principles and could actively participate in making the changes effective. Continuous improvement also included tracking performance metrics in real-time, allowing the team to address minor inefficiencies before they escalated into major production obstacles.

The results of this Lean transformation were impressive. Within a few months, the company achieved a 25% increase in production output, allowing them to meet demand more effectively. Batch processing times were reduced by 30%, ensuring that products reached the market faster without compromising on quality. Importantly, the emphasis on quality improvement led to more consistent product standards, boosting compliance with regulatory requirements and enhancing the company’s reputation for reliability.

This success story demonstrates that operational excellence in pharma manufacturing goes beyond simple cost-cutting. By implementing Lean Manufacturing principles, we not only reduced waste and improved efficiency, but also created processes that consistently delivered ‘value’ and fostered a culture of continuous improvement within the company. Also, this proved that operational efficiency and product quality can go hand-in-hand when approached strategically.

Further, the transformation strengthened the company’s market position and provided them, a sustainable framework for future growth.

If your organization is looking for results like these, let’s connect to explore how operational excellence can unlock your full potential. 
 

Keywords and Tags:
#LeanManufacturing #Reducewaste #PharmaManufacturing #OperationalExcellence #ContinuousImprovement #ProductionEfficiency #ProcessOptimization #PharmaQuality #ComplianceStandards #ManufacturingSuccess #OperationalImprovement #LeanPrinciples #BatchProcessing #QualityControl #PharmaSuccessStory

More Operational Excellence Case Studies at: https://www.drshrutibhat.com/blog/category/case-studies

Categories:  Life Sciences | Lean | Operational Excellence

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Don’t have a large team or budget to execute Lean Six Sigma, TQM, ISO or such process improvement methodology at your workplace? Not to worry, it is the attitude of continuous improvement which is vital for creating operational excellence.

Many small organizations have human resources and/or budget constraints. But even with a small team of a single employee and an optimistic attitude of continual improvement, organizations can create operational excellence by installing Lean Kaizen.

Though, Lean Kaizen here has been illustrated in the pharma sector, the principles can be extended and used in any manufacturing sector.

Checkout the whitepaper...

Feel free to download this whitepaper for personal reading, but not for sale or resale. Hope you find it helpful. Reach out to me if you have questions.


Related Reading

1. How to cut costs strategically using Kaizen
2. Revolutionizing industries with Lean Six Sigma
3. Streamline processes and workflows with Gemba Walk.
4. Top Ten Strategic Decision-Making Tools for Operational Excellence
5. Popular Continuous Improvement Workshops & Webinars for Manufacturing Industries
6. Mistake-Proofing Pharmaceutical Product Development, Manufacturing and Logistics, Cost Savings via Poka Yoke
7. Popular Continuous Improvement Tools.

Follow Shruti on Twitter, YouTube, LinkedIn

Categories: Kaizen | Life Sciences | Whitepaper

Keywords and Tags:

​​#Kaizenforpharma #LeanKaizen #StrategicKaizen #kaizen #operationalexcellence #continuousImprovement #ProcessImprovement  #ProcessEfficiencyImprovement #BusinessProcessImprovement #BusinessTransformation  #JapaneseKaizen #KaizenEvents #processoptimization

Lean Kaizen:

Lean Kaizen is a continuous improvement methodology to get rid of excess waste involved in a process. Lean identifies waste as- Muda (waste in manufacturing system), muri (waste due to overburden) and mura (waste created due to unevenness of workloads). Kaizen is the foundation of Lean methods of production and focuses largely on reducing, or eliminating waste, increasing productivity, and attaining continual improvement of organizational processes.
 
Lean Kaizen incorporates Kaizen’s ideas of continual improvement and focuses on making/ applying small changes for a significant amount of time, to achieve desired results. This method involves all types of employees (i.e. full-time, part-time, contract etc.) at different levels within the company and requires complete involvement by everyone, to allow anyone to speak up regarding problems being faced at the workplace and ways of improvement.
 
The main technique often used here involves analytical aspect and includes methods such as ‘5-Whys’ and ‘Ishikawaka’ to pinpoint ways of reducing waste in certain areas of production.  A Kaizen implementation plan is then designed, which is often applied almost immediately. The solutions involved are typically minute and more solutions are added as problems arise.
 
It is necessary to assess and follow up on the actions for improvement, to be able to analyze how well the plan is working and to make sure that it continues to be applied for a long period. The system of Kaizen allows all employees to have a say in the decision-making and boosts employee morale within a company. Since this method is continuous in action, employees can choose to speak up on issues when they occur – which allows for solutions to make a significant impact. Therefore, solutions via Lean Kaizen methodology are absolutely customized to the type of problems occurring in a section or department. Hence, Lean Kaizen creates a customized solution not only specific to an industry segment but it is company- specific too.
 
Though Kaizen does appear to focus on fixing manufacturing process related problems, it is also used to improve the organization as a whole. Hence, Lean Kaizen plays a critical role in overall business process improvement.
 
Anything that positively contributes to the safety, efficiency or productivity of the organization is greatly valued in Lean Kaizen methodology. While employees can come up with ideas at their own leisure, it is often encouraged by organizations to arrange brainstorming sessions on a regular basis. Typically, in a brainstorming session, employees are given a topic to focus on and discuss possibilities of improvement regarding the given subject.
 
It is most effective for these brainstorming or Kaizen sessions to include around five to seven people. The numbers vary on the company size, markets of operation, employee strength, number, frequency, and magnitude of problems etc. Organizations targeting improvement via Lean Kaizen should generally allow for employees that are involved in the session to have some time off during their workday to come up with solutions. The reason Kaizen sessions work well is because different viewpoints are heard and can help bring about a solution that works for all.

Lean Kaizen is extremely difficult to implement in life sciences companies viz. pharmaceuticals, herbal products etc. Lean advocates small batch sizes. Improper use of Lean Kaizen on a pharmaceutical company shop floor produces poor operational output. For example- small batch sizes may mean higher percentage of granules wasted on a high-speed tablet-press, while working on low-speed tablet machines would directly impact productivity negatively.
 
Implementing ‘one piece flow’ i.e. a process in which each product moves through the production process, one unit at a time, is difficult to implement in the traditional pharmaceutical manufacture of capsules, tablets and other dosage forms. One piece flow might, however, work with additive manufacturing i.e. 3D printing.
 
Furthermore, pharmaceutical manufacturing requires meticulous cleaning and line clearance between batches, unless it is a dedicated line for a product. To avoid line clearance procedures for dedicated lines, batches must have same blend compositions and products be dose proportionate. What that means is- if a tableting line produces Product A having multiple strengths 100 mg, 150 mg, 200 mg and 300 mg, then batch of 100 mg label claim must be manufactured first, followed by others in ascending chronology.
 
In all other scenarios, such as, non-dedicated lines, different blend compositions and/or non-dose-proportionate products, obtaining line clearance between batches is a must. This stipulation disallows quick changeovers on the shop floor. For example, a clean-in-place process may require a full day and line clearance may not be received as test results may not be available to QA. Such incidences usually happen since line clearance tests are complex and take time. For example- if a microbiology study is involved, line clearance test results may get delayed by 5-15 days!
 
Lean manufacturing technique cannot be applied as-is to pharmaceutical Ops. However, Lean principles combined with Kaizen philosophy can be applied to improve pharmaceutical operational productivity, control WIP, reduce cycle times, variations and enhance process efficiency.
 
Some of the key scenarios where improvement via Lean Kaizen is extremely helpful:

• Ailing business needs a turnaround.
• Little or no leadership from top management.
• Persistent cashflow problem.
• Infrequent management reviews.
• Top talent not used adequately.
• Poor support from finance, IT, maintenance team, human resources, marketing, R&D functions to manufacturing.
• Trouble-shooting expertise within manufacturing is inadequate.
• High manufacturing overhead.
• Company wants to implement advanced manufacturing techniques, go for automation, digitalization etc.
• Poor collaboration between various functions within the organization.
• The focus is on training, not on improvement.
• Poor communication of initiatives and progress- tracking.
• Lack of appropriate recognition and rewards.
• Projects not tied to business goals.
• Poorly defined project goals, scope, and metrics.
• Project management effectiveness is poor, for example- too many scope creeps, projects going over-budget or over-timelines etc.
• Wrong project teams.
• Infrequent team meetings.
• Quality problems in processes, products, and services.
• Too many non-compliances cited during audits.
• Delays with procurement and irregularities with supply chain.
• Vendor management needs to be improved.
• Delays with hiring. Too many open positions in the organization.
• Backorders at shopfloor; demand not met despite infrastructure capability.
• Lot of reworks.

Benefits of Lean Kaizen:

Lean Kaizen methodology involves making small changes within an organization and implementing these changes on a continuous basis. These improvements allow organizations to reduce waste and improve productivity. The method involves all workers of the company and allows everyone to have a say regarding possibilities of improvement, as well as pinpointing methods that are not efficient or could be made better. Unlike workshops that take place annually or monthly, Lean Kaizen is implemented regularly and continuously.
 
The ideas that are addressed in Lean Kaizen are often small since this method works effectively when small changes are made. These small changes tend to improve important aspects of the company such as efficiency, safety, and productiveness. Aside from working on aspects that are deemed problematic within a process, Lean Kaizen also encourages workers to speak up regarding all aspects of improvement.
 
The best advantage of Lean Kaizen is that it greatly reduces waste. This can include waste from transportation, supply chain logistics, skills, inventory, processes, and production. It also lowers costs, increases safety, allows for more efficient delivery, and improves customer satisfaction.
 
Another advantage of implementing Lean Kaizen is that it creates a lot of clutter-free space due to the elimination of unnecessary items. It also increases the quality of the product, uses assets in a better manner, improves communication and allows employees to feel valued in the company. Since employees are a significant part of the Kaizen campaign, they feel empowered and contribute to the organization’s cause in a big way and tend to augment their loyalty and dedication.
 
Employees that are continuously assessing their environment to find methods of improvement have a higher chance of addressing necessary changes within the workspace. Since employees that are involved tend to have higher morale, they work more effectively and experience more job satisfaction.
 
Since Lean Kaizen focuses on making small changes, the results are immediate. When an organization chooses to undergo large changes, it takes much more time to see results and there may be several negative drawbacks as well.
 
It is still necessary for companies to undergo large changes for certain projects. However, Lean Kaizen has a positive effect on the entire process by making it easier to implement in increments and to analyze detailed aspects as well as the bigger picture.
 
The reason Lean Kaizen is widely used and favored is because it is a continuous method that continually makes little improvements, that greatly improves the processes of an organization and lowers waste.
 
Lean Kaizen is used by life sciences companies throughout the world and continues to work well for organizations of all sizes and segments. However, it is good to be aware of the limitations of Lean Kaizen before implementing this method to your organization.
 
Limitations of Lean Kaizen:

A large drawback of Lean Kaizen is that it requires organizations to change their governance style and communication methods. It can be hard for companies that are used to working in a certain way, to suddenly make changes to their work style. For Lean Kaizen to take off the ground, companies must allow open communication and empower employees to speak up on issues around their workplace. Lean Kaizen will not work at all sans transparent dialogues between everyone in the workplace.
 
Another limitation noted in Lean Kaizen is that this method focuses largely on reducing waste, which can withdraw focus from other important aspects. Change management procedures must be extremely efficient to make the Lean Kaizen campaign a success.
 
Usually implementing Lean Kaizen has a positive spin on employees (since they are valued), however, it can rake-up fear of losing their jobs or may feel threatened because changes at workplace might displace them from their ‘comfort zone’.
 
It is necessary for all employees to be well-informed and aware of the real reasons for implementing Lean Kaizen. Otherwise, the drive that motivated workers during the initial stages can dwindle down over time. This is especially harmful if the solutions have not yet been put to action. The organization will not receive the desired results and can deter employees from wanting to continuously use Kaizen strategy.
 
Implementing Lean Kaizen can be quite stressful since it becomes a new focal point within the organization. It can cause the work area to become more detached and objective since employees may feel continuous pressure to exceed their prior performances. If stress levels in workers become too high, then it can have a negative effect on both efficiency and productivity of the workforce.

Conclusion:

Implementing Lean Kaizen principles for process optimization in pharmaceutical manufacturing is a journey that requires commitment, teamwork, and continuous effort. However, the benefits are well-worth the investment. By focusing on continual improvement, waste reduction, standardization, and employee engagement, pharmaceutical companies can achieve greater operating efficiency, higher product quality, and a competitive edge within the sector.
 
Lean Kaizen's principles align with the pharmaceutical industry's commitment to providing safe, efficacious, cost- effective and patient-centric medications while striving for innovation and operational excellence. Learn more about how Kaizen can help your company here.

An important point to note is that Lean Kaizen is a top-down methodology, so it starts at the top of the management ladder. Company leaders must believe in the Lean Kaizen philosophy and visualize ways to use Lean Kaizen to improve their business. Next this vision and Lean Kaizen mission must percolate down in the organization so that employees are excited to participate in the process improvement campaign. Do you know, a highly motivated Lean Kaizen workforce can bring about big process improvements in as less as 7 days!

If you are looking to install strategic Lean Kaizen process improvement initiatives at your workplace, let's talk...
Contact us at https://www.drshrutibhat.com/contact.html 

Checkout more on Lean Kaizen in my book Kaizen for pharmaceutical, medical device and biotech industries.


Related reading:

1. How to cut costs strategically using Kaizen
2. Revolutionizing industries with Lean Six Sigma
3. Streamline processes and workflows with Gemba Walk.
4. Top Ten Strategic Decision-Making Tools for Operational Excellence
5. Popular Continuous Improvement Workshops & Webinars for Manufacturing Industries
6. Mistake-Proofing Pharmaceutical Product Development, Manufacturing and Logistics, Cost Savings via Poka Yoke
7. Popular Continuous Improvement Tools.

Follow Shruti on Twitter, YouTube, LinkedIn


Categories:  Whitepaper | Kaizen | Operational Excellence


​Keywords and Tags:

#Kaizenforpharma #LeanKaizen  #ContinuousImprovement #ProcessImprovement  #ProcessEfficiencyImprovement #BusinessProcessImprovement #BusinessTransformation  #JapaneseKaizen #KaizenEvents #processoptimization

This multi-part blogpost series presents practical answers to frequently asked questions on improving business entities.

Its objective is to assist business leaders in these trying times, whether they are learning the basics of business process improvement, planning their first business improvement project, or evangelizing process-oriented thinking throughout their organization.
 
So, let’s get started …
 
Few similarities are- Both Lean and Six Sigma methodologies bring-forth positive business transformations. Both improve relations between ‘Voice of customer’ (VOC) and ‘Voice of process’ (VOP). Both bring-on process improvement, reduce operational cost and increase profit.
 
A major difference is in their process improvement philosophy- Lean focusses on eliminating ‘process wastes’, while Six Sigma focusses on eliminating ‘process defects and variations’.
 
Check out more about Lean, Six Sigma and eighteen different business process improvement techniques here.
 
I shall discuss more FAQs concerning effective & efficient business process improvement in upcoming parts of this blog post series...
 
By the way, if you run a company that is facing a challenge to thrive in these difficult times, I would suggest that you please revisit your business processes in order to accelerate growth and bring a quick turnaround.

Keywords and Tags:

#businessprocessimprovement #leanmethodology #sixsigmamethodology #leansixsigmamethodology #differencebetweenleanandsixsigmamethodology #similaritiesbetweenleanandsixsigmamethodologies #differencebetweenleanandsixsigmaprocessimprovementmethodology #businesstransformation #businessturnaround     #processimprovement   #continuousimprovement   

Here is a case study that exemplifies ​improved productivity of pellet manufacturing by 28% per shift via LEAN. 

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:

​#Manufacturing #Lean #ContinuousImprovement #Kaizen  #QualityImprovement  #ManufacturingManagement  #Pharmaceutical  #LifeSciences  #Food  #Beverage  #Biotechnology  #LeanManagement 

​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’. 

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:

​​#Kaizen  #HR #ProcessExcellence  #ContinuousImprovement   #BusinessProcessManagement  #ServiceIndustry    #BPM #LeanManagement  #KaizenLeaderMasterclass  #kaizenInHR

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

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