Operating Efficiency Expertise:​​​

Shruti improves Operational Efficiency by strategic use of-
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Process design, Mistake-proofing products & processes, Operations management, Change management, installing a culture of Quality, Employee engagement and Continuous improvement.

Achievement Dashboard:

  • ​​Productivity improved: 10 – 250%
  • Operational efficiency increased: 15 – 40 %
  • Speed to market improved: 5 -40 %
  • Process control: Stopped back orders by 100%
  • Cost reduction: 15- 45 %
  • Cycle time reduction: 5 -15%
  • Defects and Rejects reduction: up to 100%

Process Design Expertise:

Shruti employs Value Stream Mapping to business process(es) to discover flaws and gaps in as-is process. Based on the findings of the value stream study, she then designs a strategy and execution plan to overhaul or redesign the process(es) as needed, to generate increased profit. She employs business improvement methodologies such as- Lean, Kaizen, TQM, Just-in-Time, ISO, 5S, Lean Six Sigma, TRIZ, Hoshin Kanrii, QbD and TPM, to improve profitability from Research, Manufacturing and Service divisions and the business in entirety.
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Over a span of a decade, Shruti has increased productivity and brought down cost in several organizations from life science, chemical, engineering and biotech sectors. 

Here are few examples of Shruti’s success with increasing Productivity and Operational Efficiency-
Just-in-Time in life science company-
Shruti employed Just in time (JIT) principles to R&Ds of pharmaceuticals, contract research organizations (CRO), natural product companies. Through flawless execution of JIT technique, Shruti succeeded in saving consumable expenses by 75-80 % which was a significant achievement towards lowering ‘overhead’ expenses for the organization. Checkout the full case study here
​ISO in HR department of chemicals and biotech company-
ISO is usually applied in operations, logistics and quality departments of chemicals and biotech plants. Shruti prepared the organization for ISO compliance audit and obtained certification in the first attempt.

In addition, Shruti applied ISO in HR department to retain talented employees. As a result, this stopped employee turnover, cost associated with out-going employee as well as the cost of recruiting and training new hires. By applying ISO techniques in HR function, Shruti succeeded in 100% talented employee retention consecutively for 3 years, which saved over half a million dollars in aggregated cost.
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Shruti then extended ISO implementation to others functions of HR department such as- recruitment process, training process, annual goal setting, year-end performance evaluation, bonus schemes, employee-engagement process generating savings of over five million dollars each year for the company.
Lean Six Sigma in CRAM operations-
Shruti applied Lean six sigma in service functions of a contract research and manufacturing (CRAM) company. This company had numerous customer complaints, short on deliveries as well as product quality problems. She applied Lean six sigma principles and reduced wastes in time, consumables, re-works, and defects. Within one year, she succeeded in eliminating product quality problems by 100%. She reduced customer complaints by 80% and delivery shortages by 70%. Additionally, she succeeded in procuring a repeat business of USD 30 million for the organization.
​Lean Kaizen in warehouse-
Shruti employed Lean principles to streamline inventories; reduce re-works, rejects and back orders which not only improved operational efficiency but also saved $200,000 annually. She also introduced a positive change in R&D work culture by successfully implementing Kaizen principles, which resulted in increased R&D productivity i.e. more formulations developed with less experiments. This not only reduced research costs but also improved overall R&D efficiency by 20%.
​Quality by design (QbD) in product development lab-
Shruti implemented QbD with Poka Yoke in pharmaceutical R&D, testing, clinical study, manufacturing, quality, warehouse, distribution & logistics and marketing functions.

By employing QbD and Poka-Yoke in combination, Shruti succeeded in increasing R&D output by 25%, shortened development timelines by 40%, increased manufacturing capacities by 30%, reduced testing costs by 10%, completely eliminated product quality complaints and improved customer satisfaction by 15%.

Shruti achieved these results by employing a strategically design QbD implementation process using ‘customer-centric innovation’ philosophy. Firstly, critical quality attributes (CQA) were assigned to incoming raw materials, machinery etc. She then prepared a target product profile, based on customer feedback (via surveys, interviews, complaints etc.).

Later, the feedback was reviewed; root- cause analysis was conducted using Ishikawa and 5 Whys concept. Appropriate CAPA (corrective actions preventive actions) was put in place. All experiments were designed using the DOE (Design of experiment) principle and edge of failure determined using the FMEA (Failure mode effect analysis) model.
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Results from QbD implementation were further augmented by use of Lean and 5S with QbD, It reduced production back-orders by 35% and inventory wastes by 25%.
​TQM in bulk drug and formulation facility-
Shruti implemented TQM in bulk drug and drug product manufacturing facility. This reduced quality complaints by 50% and re-works by 15%.
​Kaizen for inventory management-
Shruti used Lean Kaizen to supply chain management functions viz. Purchase, negotiations, contracts, vendor development, vendor approval, vendor ratings, warehouse stocking (EOQ, ABC and VED analysis) and material requirement planning (Linear programming and MRP).

Checkout more Case Studies here.

Mistake-proofing and Operations Management Expertise:

​Shruti employs FMEA, CAPA, Poka Yoke or Hoshin techniques to mistake-proof products and processes. She improves process capability to a statistical control of Cpk 1.5 or higher. ​With combined use of operations management and mistake-proofing techniques, Shruti re-balances manufacturing lines and service operations to cut costs, reduce cycle-times, back-orders, plug bottlenecks, increase capacity-utilization and reduce over-heads. 

Shruti has improved operational efficiency for several manufacturing and service operations such as-
Manufacturing operations:
  • Aerosols, perfumes, inhalation, and nasal sprays.
  • Ball milling, compaction, granulation, tableting and capsulation.
  • Extrusion- spheronization and pelletization.
  • Fluidized bed drying, coating and spray congealing.
  • Holt-melt polymerization and injection moulding.
  • Liposome, niosomes and nanotechnology.
  • Creams, pastes and gels.
  • Powders, Quasi and Solid dispersion.
  • Emulsions.
  • Polymer cross-linking and resin.
  • Maceration, brewing. extraction and fermentation.
  • Sterilization and aseptic manufacture.
  • Form-fill-seal.
  • Strip, blister and pouch packing.

Service operations:
  • Supply chain logistics and delivery.
  • Warehousing and material issue.
  • Internal audit process.
  • Infrastructure development process.
  • Sales process.
  • Branding & Marketing process.
  • Employee-engagement process.
  • Innovation management process.

Change and Quality Management Expertise:

​Shruti has over 17 years of hands-on expertise with facilitating start-ups and growing companies towards building 'Quality' and Quality-by-design (QbD) culture in their organization. She is hands-on with various change management tools such as PROSCI, 8D, ADKAR, Kotter, McKinsey and Lewin change models. 

​Through effective installation of quality management systems (QMS) Shruti has reduced rejects, defects, scrap and cut cost.

Shruti specializes in full spectrum of quality management comprising:
  • Facility design and set up.
  • Quality management systems (QMS) planning and execution.
  • Quality- by- design (QBD) implementation from development through commercialization.
  • Vendor audits, qualification and vendor management.
  • Supply chain logistics management.
  • Regulatory compliance and regular upgrades.
  • Operations monitoring and data management.
  • SOP document creation, maintenance, training and records.

Audit Expertise:

​Shruti specializes in different types of Internal, External and Third party AUDITS such as- Compliance audits, Special investigations/ Due diligence, Operations audits, Departmental reviews and Follow-up audits.

Shruti has conducted numerous Due Diligence and more than 500 Quality Audits across the globe, comprising-
  • Pre- Merger & Acquisition audit.
  • Pre-purchase vendor site qualification and capability audit.
  • Warehouses, Transportation and Distribution channels audit.
  • Safety testing labs, GLP-Chemicals and Analytical testing laboratory audit.
  • cGMP- contract manufacturing sites audit.
  • Gap analysis, OOS, CAPA inspections and follow-up audit.
  • Machinery audit prior to procurement, Factory acceptance test (FAT), Site acceptance test (SAT).
  • Clinical research organizations (CROs), hospitals, pathology, microbiology and biochemistry labs.
  • Chemical reactors site audit for drugs, fine chemicals and foods.
  • Fermentation reactor site audit for vaccines and biotech.
  • R&D audits for product development, outsourcing and In-licensing.
  • Building management systems (BMS) audit.
  • Electronic document management systems (21 CFR, Part 11 compliance).
  • SOP and Training records audit.
  • Identifying ways to prevent product counterfeiting.
  • Intellectual property audit.
  • Due Diligence prior to Acquisition, Merger, Outsourcing. 
  • Do you wish to embed a culture of 'Continuous Improvement' in your organization?
  • Do you wish to introduce a 'Culture of Quality' at your workplace?
  • Do you wish to improve your company's Procurement / Sourcing, Distribution and Supply Chain Logistics?
  • ​Do you wish to increase Sales?
  • Want to bring about Manufacturing Excellence?
  • ​Do you wish to turnaround a sick business?

​To learn more, consult with Shruti or book a workshop, seminar. Contact via Form or WhatsApp 1.403.969.6219
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Shruti's best-selling paperbacks …
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