APEX GROUP OF INSTITUTION AND TECHNOLOGY

SUMMER INTERNSHIP

(JUNE-JULY 2016)

AN INTERNSHIP PROJECT REPORT BY:

ADITYA SINGH

B.TECH. (MECHANICAL ENGINEERING)

BATCH 2013-2017

INTERNSHIP WITH:

BAJAJ AUTO PRIVATE LIMITED

UNDER THE GUIDANCE OF:

Mis. Yashika Arora

(Seinour engg. Engine Assembly)

1 ENGINE ASSMBLY

ENGINE ASSEMBLY

HIDDEN LOSSES

SUBMITTED TO: SUBMITTED BY:SUBMITTED TO: SUBMITTED BY:

YASHIKA ARORA ADITYA SINGH YASHIKA ARORA ADITYA SINGH

ENGG. ENGINE ASSEMBLY B.TECH (ME) ENGG. ENGINE ASSEMBLY B.TECH (ME)

BAJAJ AUTO PVT LTD. APEX GROUP INSTITUTIONBAJAJ AUTO PVT LTD. APEX GROUP INSTITUTION

RAMPUR (U.P) RAMPUR (U.P)

2 ENGINE ASSMBLY

CERTIFICATE

This is to certify that ADITYA SINGH, student of B.Tech (Mechanical

Engineering) has undergone industrial training with this company (Bajaj Auto

Pvt. Ltd.) under my supervision and guidance. During the internship he was

assigned the under mentioned tasks:-

Which he …………… (Please write few lines on how the student performed the

task, his conduct and any special contributions)

Date:

Name and Designation:

Signature

Seal/Stamp of the Organization

3 ENGINE ASSMBLY

Acknowledgement

It is a great pleasure to present this report of summer training in BAJAJ AUTO PVT LTD in partial fulfillment of B.Tech programme under APEX GROUP OF INSTITUTION , AKTU. At the outset, I would like to express my immense gratitude to my training guide, Mr. Dinkar panday (Engine Assembly Head).

And my heartiest thanks to Mis. Yashika Arora (Seinour Engg. Engine Assembly) for guiding me right from the inception till the successful completion of the training. I am falling short of my words for expressing feelings of gratitude towards him for extending his valuable guidance about “ENGINE ASSUMBLY” & support for critical reviews of project & also moral support he had provided me throughout the training.

Training guide: Trainee:

Miss. Yashika Arora Aditya Singh

4 ENGINE ASSMBLY

PREFACE

The four year B.Tech Program is a full time technical course which helps in immense learning of technological aspects, similarly the project helps us in enhancing our learning by adding more to our world of knowledge & summer training is the part of B.Tech to nurture our technical skills.

Bajaj Auto Pvt. Ltd., Pantnagar gave me the chance for exposure to the industrial practices and techniques. Here I got the practical knowledge of many theoretical concepts.

I worked under ENGINEERING DEPARTMENT (ENGINE ASSEMBLY)

It was a life time experience for which I thank all the staff members of Bajaj Auto Pvt. Ltd., Pantnagar.

5 ENGINE ASSMBLY

ABSTRACTIndustries that utilize the engine assembly line to obtain their products currently go through great challenges. The first is the need to assemble a large number of product models and their variants in their lines, due to the variety required by the market. Another challenge is the need to maintain an adequate level of manpower occupation reduced hidden losses and other utilized resources. In this scenario the activity of reduced hidden losses in operations appears. In order to increase the efficiency and reduce the operating costs of the line, and non value added activities among workstations are performed. They can be done by different methods, such as: reducing non value added. In engine assembly lines that produce more than one model, total and individual engine assembly times are often different among models, so the operation time of each station varies from model to model. By elimination of non-value added activities in lines that produce more than one model can be performed by using the weighted averages of the times of the different models.

6 ENGINE ASSMBLY

Another possibility is to use an objective function that considers the imbalance among the models and try to minimize it. Quality is the assurance of adherence to the customer specifications and it is a measure of excellence or a state of being free from defects, deficiencies and significant variation from standards. Customer specification of the product can be met by strictly adhering to the quality control measures in the production process and can be ensured in a cost effective manner only if the quality of each and every process in the organization is well defined and ensured without any lapses. Every activity in the supply chain line to be critically verified to identify the quality deviations incurring additional expense or loss to the organization. This is in line with the continual improvement principle of TQM philosophy. The cost of quality management system acts as the most significant tool in measuring, monitoring, controlling and decision making activities in a firm which aims on business excellence.

7 ENGINE ASSMBLY

TABLE OF CONTENTS

Certificate

1. Acknowledgement2. Abstract3. Table Of Contents4. Company Profile

a. Bajaj Company Profile b. Pantnagar Plant

5. Vendor’s List6. Engine Assembly7. Introduction of hidden losses 8. Process9. Type of wastes

1. 0ver-production2. Waiting time3. Transportation4. Motion losses5. Inventory6. Over-processing7. Scraps

10. Characteristics of Hidden losses11. Tools and Techniques Used in Waste Reduction Efforts 11. Investigation and Prevention of Hidden Losses12. Conclusions

8 ENGINE ASSMBLY

COMPANY PROFILE

BAJAJ – Company Profile

History

Bajaj Auto came into existence on November 29, 1945 as M/s Bachraj Trading Corporation Private Limited. It started off by selling imported two- and three-wheelers in India. In 1942, his son Kamalnayan Bajaj took over the charge, he not only consolidated the group, but also diversified the group into various manufacturing activities.The present Chairman of the group, Rahul Bajaj, took charge of the business in 1965. Under his leadership, the turnover of the Bajaj Auto the flagship company has gone up from INR.72 million to INR. 120 billion, its product portfolio has expanded and the brand has found a global market of Bajaj Auto Limited is a major Indian automobile manufacturer having a turnover of 120 billion rupees.

The Bajaj Group is amongst the top 10 business houses in India. Its footprint stretches over a wide range of industries, spanning automobiles (two-wheelers and three-wheelers), home appliances, lighting, iron and steel, insurance, travel and finance. The group's flagship company, Bajaj Auto, is ranked as the world's fourth largest two- and three- wheeler manufacturer and the Bajaj brand is well known across several countries in Latin America, Africa, Middle East, South and South East Asia.

9 ENGINE ASSMBLY

Manufacturing Location Bajaj Auto’s has in all three plants, two at Waluj and Chakan in Maharashtra and one plant in Pantnagar in Uttrakhand. Waluj – Bajaj range of Motorcycles and three-wheelers. Chakan – Bajaj range of Motorcycles. Pantnagar – Bajaj range of Motorcycles.

Key Milestone

1945 – Bajaj Auto comes into existence as M/s Bachraj Trading Corporation Private Limited.

1948 – Sales in India commence by importing two- and three- wheelers.

1959 – Bajaj Auto obtains license from the Government of India to manufacture two- and three- wheelers.

1960 – Bajaj Auto becomes a public limited company. 1970 – Bajaj auto rolls out its 100,000th vehicle. 1971 – The three-wheeler goods carrier is introduced. 1972 – The Bajaj Chetak is introduced. 1975 – BAL & Maharashtra Scooters Ltd. Joint venture. 1976 – The Bajaj Super is introduced. 1977 – The rear engine Auto rickshaw is introduced. Bajaj Auto

achieves production and sales of 100,000 vehicles in a single financial year.

1981 – The Bajaj M-50 is introduced. 1984 – Foundation stone laid for the new plant at Waluj, Aurangabad.

1985 – Production commences at Waluj, Aurangabad.

1986 – The Bajaj M-80 and the Kawasaki Bajaj KB100 motorcycles are introduced.

1986 – The Bajaj Sunny is introduced. 1991 – The Kawasaki Bajaj 4S Champion is introduced. 1994 – The Bajaj Classic is introduced.

10 ENGINE ASSMBLY

1995 – Agreement signed with Kubota of Japan for the development of diesel engines for three – wheelers and with Tokyo R&D for ungeared Scooter and moped development.

1997 – The Kawasaki Bajaj Boxer and the RE Diesel Auto rickshaw is Introduced.

1998 – Production commences at Chakan and India First Four Stroke scooter rolls out of Akurdi.

1999 – Caliber Motorcycle notches up 100,000 sales in record time of 12 months.

2000 – Bajaj Saffire is introduced. 2001 – Bajaj Auto Launched its Premium Bike Segment ‘Pulsar’. 2003 – Bajaj Pulsar DTS-I is launched. 2004 – Bajaj Discover DTS-I and New Bajaj Chetak-4 Strike with

wonder Gear Launched. 2005 – Bajaj Avenger DTS-I launched. 2006 – Bajaj Platina launched, Foundation stone laid for the new

plant at Pantnagar, Uttrakhand. 2007 – Bajaj XCD 125 DTS-I, Bajaj Pulsar 220 DTS-Fi, 200 cc Pulsar

DTS-I launched and Production commences at Pantnagar. 2008 – Bajaj Platina 125 DTS-I and Bajaj Discover 135 DTS-I

Upgrade launched. 2009 – Bajaj Pulsar 150 & 180 upgrade launched. 2010 - BAL achieves BS III norms on entire 2-wheeler range.2011 – Bajaj Pulsar 200 upgrade launched.2012- Bajaj revised Pulsar 200cc liquid cooled engine.2013 – Bajaj launched three new models 100T, 100M, and 125T

powered by worlds first 4 value twin spark DTSi engine.2014 – Bajaj Discover 150F and 150S launched.2015 – Bajaj Platina 100ES, CT 100 (Reintroduce), Pulsar

200RS ,200AS, and Bajaj Avenger 150 & 220 street.2016 – Bajaj V15 Launched.

11 ENGINE ASSMBLY

Pantnagar Plant

HISTORY

Foundation stone- April 2006 Plant Inauguration- 9th April 2007 Commercial Production Start- 9th April 2007

INVESTMENTS

Total investments made into this factory- Rs.1.73billlion (Rs. 173 Corers).

AREA

BAL-Pantnagar Plant Area-60 acres And 180 acres of the plant area has been taken up by 16 vendors to set up a dedicated facilities-and Thus ensure seamless integration with the mother plant.

12 ENGINE ASSMBLY

DEPARTMENTS 1. Vehicle Assembly

2. Engine Assembly

3. Paint Shop

4. Production, Planning and Control (PPC)

5. Vehicle Dispatch

6. Utility & Services

7. HR & Admin.

VENDOR’S LIST

13 ENGINE ASSMBLY

S.NO Vendor's Name S.NO Components

1 Varroc 1 Seat

2 R. R. Unit

3 C D I

2 Badve 1 Frame Assembly

2 Silencer

3 Gear Shift Lever

4 Hanger Bracket

5 Engine RH Bracket

6 Engine LH Bracket

3 Pricol 1 Speedometer Assembly

2 Fuel Gauge

4 AEL 1 Front Brake Assembly

2 Rear Brake Assembly

5 Roop Polymers 1 Battery Arrester or Band

14 ENGINE ASSMBLY

2 RR Cover

6 Minda Corp. Ltd. 1 Lock Set

2 Handle Holder

3 Fuel Cap

7 Advik 1 Fuel Cock

8 Minda Industries 1 Handle Bar

9 Lumax 1 Fairing

2 S.P.M. Flap

10 Endurance 1 Front Fork

11 NAPL 1 Frame Assembly

2 Chain Case & Fuel tank

12 MMT 1 Frame Assembly

INTRODUCTION

15 ENGINE ASSMBLY

The Hidden Factory is a term that refers to activities in an operation or standard operating procedure (SOP). A few examples of Hidden Factories are workarounds, rework, or any of the 7 wastes, which I will describe below. Most organizations have some form of a Hidden Factory and being able to “see” these hidden factories in an organization requires learning to see what waste is and understanding that waste in Assembly operation — service or a — can be a substantial drain on the bottom line, top line, on employee A strong control over the management of utilization of resources of all categories in a manufacturing process becomes the demand of the day due to the high competition among the players of the present market. The resources-man, material, machine and time-to be utilized in a most cost effective manner to ensure the profitability of any business and at the same time no compromise in the quality is permissible. This is the highly competitive globalized market scenario today. Hence management and financial accounting have an important role in the measurement and control of the components of assembly costs. On the other hand quality improvement programs for attaining continual improvements have become essential to any business organization to thrive forward profitably with enhancement in its customer base. The question is how to achieve both these objective without losing organizational interests. Cost of quality has evolved as the answer to this question. Cost of quality analysis is considered as one of the most effective management tool for gathering and analyzing the expenses in maintaining quality in a assembly process and also identifies the non-value added expenses. Quality improvement International Journal of Managing Value and Supply Chains (IJMVSC) Vol. 6, No. 2, June 2015 14 programs can be critically analyzed using quality costing techniques to check the merit

16 ENGINE ASSMBLY

of the program. This helps the management to identify the areas for improvement in quality as well in reducing wastages and hence ensure profitability. Morale, shareholders and, most importantly, the customer. A process is a systematic activity comprising of smaller activities that culminate in an outcome — service or product. Cycle time is the total time from the beginning to the end of your process, as defined by you and your customer. Cycle time includes process time, during which a unit is acted upon to bring it closer to an output, and delay time, during which a unit of work is spent waiting to take the next action. Many models of quality cost analysis have been evolved since the inception of this concept by the quality guru Dr. Joseph Juran in 1950. The classical PAF model by Feigenbaum (1956) which distinguishes quality costs into Prevention-Appraisal-Failure categories, Process Cost Model by Marsh and Ross (1976) classifying quality costs into cost of conformance and non-conformance in the manufacturing processes, Opportunity Cost Model by Sandoval- Chavez (1998) with the addition of opportunity losses to the other traditional models and the ABC-COQ integrated model by Tsai (1998) are the prominent models among them. Many more dimensions have been added to the quality cost analysis by researchers like Steve Elridge (2006) who has added knowledge management concept to quality, Sower etal (2007) who has analyzed the quality cost as a measure of system maturity with the analysis of the relationship between quality and quality costs and Ali Uyar (2008) and Zulnadi yakup (2010) who have analyzed quality cost as money invested and money lost.

PROCESS:

17 ENGINE ASSMBLY

A process can take up time, space, and resources. All processes can be categorized into the following categories: Value-added, Non-value added but necessary and Non-value added.

There are three type of process…….

1. Value-added2. Non-value-added3. Non-value-added but necessary

1.Value-added This step in the process adds form, function, and value to the end product and for the customer. An activity is classified as value added if it is effective. In other words, if the activity directly contributes to satisfying the customer's expectations, it is a value added activity. Any activity which improves the customer's perception of the product or service is a value added activity. Production type activities are value added activities (e.g., taking customer orders, receiving materials, assembling materials).

18 ENGINE ASSMBLY

2. Non-value added: This step does not add form, function, or assist in the finished goods manufacturing of the product. In order to reduce cost while keeping up with the competition, non-value added activities might be eliminated, non-value added activities might be reduced, or simplified by becoming ‘lean‘ (mud). Typical non-value added activities include reviewing, counting parts, inspecting, testing / checking, filling information, obtaining multiple approvals, revising / reworking, reporting. These activities do not help create conformance to the customer’s specifications; they are something for which the customer should be unwilling to pay a premium for. Some activities are essential for the process for traceability and accountability or are required to meet company or regulatory policies, such like sign-offs, approvals, etc. Consequently, such activities do not directly contribute to manufacturer’s profits and are considered non-value added activities.

3. Non-value added but necessary: This step does not add value, but is a necessary step in the final value-added product. Non-value-adding activities that is necessary under the present operating system or equipment. They are likely to be difficult to remove in the short term but may be possible to eliminate in the medium term by changing equipment or processes. Often use to describe regulatory compliance activity that adds no direct customer value but is required to maintain the license to operate.

19 ENGINE ASSMBLY

Non-value added & Non value added but necessary Naturally create 7 type of waste

Over-Production Producing more than is needed, faster than needed or before needed

Waiting time Idle time that occur when co-dependent events are not synchronized

Transportation Movement of materials or people that does not add value

Motion Unnecessary movement resulting in delays or inefficiencies

Inventory Material supply in excess of that required to meet customers’ demands

Over-processing Material supply in excess of that required to meet or processes

Scraps Product, service or documentation imperfections nonconformance, or errors

1. Over-Production: Producing more than is needed, faster than needed or before needed. Over-production is the worst of the seven wastes of lean manufacturing overproduction is making products in too great a quantity or before it is actually needed leading to excessive inventory. Overproduction is the worst of the seven wastes as it obscures all of the other problems within your processes. Making more than is necessary is a very common practice among

20 ENGINE ASSMBLY

biopharm companies. While it may seem logical to keep the shelves stocked and customers instantly gratified, there are some serious risks and costs involved in making more than necessary, such as product expiration, possible contamination from outside sources, deteriorating product quality, etc. Some of these outcomes could have major con-sequences to the patient and possibly the corporate image. The principles of Lean assembly require you to make what the customer wants when they want it, pulling only what is ordered through your work flow. Just in Time manufacturing is possible in any industry with ingenuity and improving technology. Another cost associated with Over-production is to do with the storage and movement of the inventory that you have created, it all requires space, it needs people and equipment to move it around and it needs containers for storage. All of this is a cost to you, if you could eliminate it the savings would be straight back on your bottom line improving your profit.

Causes of the Waste of Over-production: We produce large batches because of long setups on some of our machines, so we try to maximize our throughput of these machines and use “economical batch quantities” to dictate how much material is processed rather than what the customer wants. We also distrust our supplier’s ability to supply what we need, so we order more than we need and sooner than we need it to ensure that we have it when we need it, this additional stress that we place on our suppliers often causes them to fail becoming a self fulfilling prophecy. We also distrust the reliability of our own processes and plan to allow for interruptions in the flow of production, often scheduling a few days or even weeks between successive operations just in case of issues or the need to change the production plan. We plan in many of our

21 ENGINE ASSMBLY

delays and inventory and many ERP and MRP systems add to this problem. We also work to forecasts; we guess what the customer will want in the future and invariably make mistakes and thus build product that is unwanted and don’t build what the customers really want.

Examples of wastes of Over-production:

Production of components before the next stage in the process is ready to receive them

2. Waiting Loss Idle time that occur when co-dependent events are not synchronized. Waiting is time wasted waiting to proceed with value added activities. Delays can result from a number of factors. Waiting for release of material or unavailability of QA/QC personnel for verifications/validations and clearances can be a large contributor to increased waiting. In one recent study (confidential client) conducted by the authors, it was observed that time spent waiting for the QA personnel to begin inspection contributed up to 42 percent of the overall cycle time. This waiting time could have been easily eliminated by proper scheduling of activities to ensure that the QA person is not required in more than one place at the same time.Unavailability of raw materials is another contributor to increased waiting time. This factor is greatly influenced by demand forecasts, reordering strategies, variability in the supply chain, environmental factors, etc. A common strategy is to order surpluses of raw materials to mitigate the risk of shortages and delays. This increases raw material inventories that occupy valuable real estate in the

22 ENGINE ASSMBLY

warehouse. As mentioned earlier, a lean operation will only carry the inventory necessary to ensure the customer is satisfied and demand is met.Improper planning and scheduling also contribute to delays. Variability in upstream processes will impact processes downstream. Delays in the upstream process significantly increase waiting time in the downstream process. Unveil-ability of equipment (processing or transport) also can add to the waiting time, e.g., unavailability of clean or sterile equipment, assemblies, and kits required for processing, etc. increase waiting time. Equipment idle time adds no value in a lean operation. Bioprocessing equipment has extremely high capital value. Not maximizing its utilization can result in higher product COGs.

Whenever an operator or machine is idle, the company is losing money and other valuable resources. Companies must pay for labor even if an operator was idle (for reasons beyond his/her control) during the shift. In these cases, operators can be reassigned to other tasks. However, if the operators are not trained in these tasks, such reassignments may not be reasonable and add little value to the overall operator utilization.

23 ENGINE ASSMBLY

3. Transportation: Excessive movement of raw materials, personnel, or paper-work can be considered NVA activities. Transportation may seem like an essential activity, but a process where every unit operation is physically located adjacent to its upstream and downstream operations does not require transportation. This is often not achievable in biopharm facilities where aseptic processing and environmental clean room classifications may require segregation of unit operations and therefore transfer stations and transporters. However, much of the cost associated with transportation and transfer waste can be attributed to inefficient processes and lack of understanding of environmental impact on the operation resulting in poor facility layout design.

Any type of transportation has cost associated with it. Some form of equipment is required, e.g., forklift, hand truck, etc., and these need to be purchased. These equipment items have an initial capital cost, recurring maintenance cost, operator costs, and other indirect costs, such as insurance, training, depreciation, cost to install traffic indicators (overhead traffic signals), etc. Automated Guided Vehicles (AGVs) are viable alternatives to manually operated equipment, but the cost of purchasing, implementing, and validating an automated system may be too high for some companies. For other companies in search of reducing headcount

and overhead while maximizing the productivity of their work force, automation may be the solution. It should be noted that employing AGVs or automation is justified when tasks are similar in nature, repetitive, and have higher frequency.

24 ENGINE ASSMBLY

Significant transportation waste can be seen if portable equipment and tanks are repeatedly moved around a facility. When a buffer hold bag is transported from a solution prep area to a chromatography suite, the bag holder and operator must pass through air locks. The operator must adorn additional gowning and spend time wiping down the bag holder. Then, once the buffer is consumed, the operator must reverse the process, and spend time de-gowning.Layouts should be designed such that sequential process steps are adjacent to each other; and material and personnel movement is minimized. Techniques like spaghetti maps or discrete event simulations can be used to analyze the distance traveled by operators in varying layout configurations. Such analysis is especially useful to analyze multi-product facilities or when the operating philosophies are still being defined.Considerable waste, in terms of time, money, and resources, also can be seen in supply chains. If a distribution center is not optimally located, the overall COGs are higher. Similarly, trucks sent to/from the warehouse without a full load also contribute to transportation wastes as the same amount of time and resources are being consumed regardless of the load.

Example of transportation

Fasteners transportation to workplace Engine transportation from unloading stage

25 ENGINE ASSMBLY

4. Motion losses : Motion itself refers to the amount of

movement an operator performs. Ideally, an operator could stand still and parts would arrive in order to achieve maximum productivity - again this is not always feasible. Every second an operator has to spend gowning, searching for a flex hose, or even sifting through computer files represents unproductive time and motion that is not spent adding value to the product. This waste can be combated by standardizing procedures, ensuring preparedness, efficient layouts, and organized work spaces, such as those seen when using the 5S5 concept, a Lean housekeeping technique.

Unnecessary motions are those movements of man or machine which are not as small or as easy to achieve as possible, by this I mean bending down to retrieve heavy objects at floor level when they could be fed at waist level to reduce stress and time to retrieve. Excessive travel between work stations, excessive machine movements from start point to work start point are all examples of the waste of Motion.All of these wasteful motions cost you time (money) and cause stress on your employees and machines, after all even robots wear out.

Example of motion losses:

People searching for materials, tools or equipment or fasteners Poorly structured or disorganized work spaces and kit bin

26 ENGINE ASSMBLY

5. Inventory: Inventory is often described as a necessary evil. Inventory consists of raw materials in a warehouse or on a shelf and finished goods. Low inventory (of raw materials) risks starving the process, while holding too much inventory can increase product lead times and warehouse space requirements. It may be difficult to strike the right balance of inventory requirements without advanced data processing or simulation.Excessive inventory of product is a result of over-production, another type of Lean waste. A study conducted by Schonberg showed that pharmaceutical companies typically carry relatively huge inventories when compared to those of other industries.4 Many companies use excess inventory to cover variability in the process or uncertainty in demand.In a truly Lean process, there is no built up Work In Process (WIP) or excess inventory. The process should include one-piece flow of product from one processing step to the next based entirely on customer pull. Raw materials arrive from the supplier only when they are needed. Finished goods are sent directly to the customer once the process is complete. This is very difficult to achieve in highly regulated industries such as biopharmaceutical manufacturing. However, a de-tailed study of material levels and root causes of variability can help lower excess inventory. Discrete Event Simulation has often been used to model the resource requirements of a process or facility in order to quantify optimal inventory levels.There are numerous costs associated with inventory. Storing raw materials prior to use requires that you have a warehouse or some type of storage facility, which includes land and construction costs. Furthermore, the materials may require tightly controlled

27 ENGINE ASSMBLY

environmental conditions adding to both the installation and operating costs. A company also must track every item that is held in inventory. The material management/tracking systems used for such purposes can become expensive as a result of increased complexity and tracking requirements. In addition, operators are required to receive, inspect, and move materials – another cost factor. There are several risks and costs associated with holding excess inventory, such as damage to raw material, due to obsolete rendering the material unusable, and contamination to name a few.

Example of inventory:

Excess production of engines Stock of engine components in store

6. Over-processing: Over-processing is the performance of operations beyond a set (or expected) quality level. If product or processes not only satisfies, but exceeds Critical-To-Quality (CTQ) and/or regulatory requirements (i.e., quality higher than a customer is willing to pay for), it can be described as over-processing. It also includes continuing to process an incorrect product. Such instances can occur if appropriate quality checks are not put in place. Processing or producing at rates exceeding requirements is also a form of over-processing waste.Quality control falls under this very broad category. A certain level of inspection is required to ensure quality and to meet regulatory expectations. Over-testing has high costs associated with it. At the

28 ENGINE ASSMBLY

other extreme, under-testing presents significant risk. Guidelines on minimum sample and quality testing requirements are provided by the Regulatory Agencies to mitigate risks associated with inadequate sampling and testing. Biopharmaceutical companies have always struggled with this balance. Statistical methods such as Six Sigma and sampling plans can be used to determine the appropriate level of quality inspection, sampling, and testing required to comply while minimizing costs. Formal risk assessments will define the areas of highest risk, thereby providing manufacturers a roadmap on where to focus their testing.Similarly, excessive documentation is another activity that can be considered over-processing waste. CTQ parameters must be monitored during batch processing and recorded in batch records. Today’s technology allows for much of this data logging to be performed automatically with any real time deviation or OOS event to be identified immediately, alarming the manufacturer and preventing subsequent manufacture of OOS product. The traditional development and maintenance of batch records can be very inefficient when non-critical information is recorded and further confirmed by secondary signatures. Time lost by operators, approvers, and/or managers on NVA activities, such as documenting unnecessary data or duplicating data, further increases the product COGs. Increased documentation or human involve-ment also increases the chance of making an error. Sometimes approvals cannot be avoided, but the fewer that are required, the lower are the costs and risks. Electronic Batch Records (EBR) can help overcome some of the problems associated with manual batch records. However, EBRs should be designed to capture the key artifacts and avoid any unnecessary inputs or information.

29 ENGINE ASSMBLY

Over-processing not only increases the overall cycle time, but also affects inventory levels. Many times companies over-process as a precautionary measure. Examples of over-processing include using intensive CIP, SIP, or cleaning regimen when lower grade cleaning/rinse may be adequate, repeating test sequences in commissioning and qualification, performing “pre-validation” activities that are non value added, processing closed unit operations in highly classified clean room environments, requiring protocol/record approval signatures of personnel or departments that cannot add value or are not Subject Matter Experts (SMEs), etc. While these activities may be necessary to some extent, they are all examples of over-processing and result in loss of material, manpower, or money in one way or another.

7. Scraps: Scraps are the most common form of waste and can be identified easily as damaged goods or non-compliant prod-uct. Scrap can be found anywhere from the manufacturing process to the analytical lab, and even in the supply chains. In a warehouse, damaged boxes from careless maneuvering can impact raw materials or finished goods, which then need to be repaired or discarded. If a shipping form is not filled out correctly (defect), it can cause delays in the assembly process, which in turn delays the shipment of finished goods to the customers. Other documentation errors that can cause delays in the process or additional corrective action are considered waste because they do not add any value to the final product.Low yield is a good indicator of high levels of defects. In an Oral Solid Dosage (OSD) manufacturing facility, a defect could be a broken tablet, or a label that does not adhere to the bottle it is attached to. Products that do not pass quality inspection are considered

30 ENGINE ASSMBLY

defective. In a cell culture process, non-conforming batches of buffer or harvest contamination are examples of defects.Many scraps can be attributed to variability within a process. According to Dr. Walter Stewart, there are two types of variability: assignable cause, which represents the randomness of a system outside the process, and chance cause, which is the variability inherent in a process.3 Lean techniques are used to eliminate assignable cause variation and bring the process into a state of statistical control where it operates within one to three sigma range. Six Sigma tools and methodologies can then be used to reduce variability and eliminate the chance cause to bring the process capability from three to six sigma. In a tightly controlled Lean process, defective product will be identified before any further NVA processing can be done on the non-compliant item. In such a scenario, no extra work is performed on a batch or drug container that is already OOS and is destined to be disposed of. This frees up resources downstream to continue processing “good” product, and eliminates further wasteful activities. The processing of OOS product is also known as “over-processing” (described below). However, it is very important to identify the underlying causes resulting in OOS products. Failure Mode and Effects Analysis (FMEA) is one of the commonly used techniques for identifying root causes, analyzing the impact of failures, and prioritizing the failure modes. Control procedures should be designed and developed around processes susceptible to creating OOS products to avoid recurrence of such instances.The costs associated with defective product or materials are primarily direct costs due to lost sales. Additionally, there can be indirect costs associated with defects such as, but not limited to, disposal costs, contamination of process streams, need for additional testing, cleaning, and sanitization. Such costs, especially disposal

31 ENGINE ASSMBLY

costs, can be very high when dealing with active pharmaceutical ingredients that may need to be stored securely and incinerated. Although it may be possible to reprocess some products, additional costs will be incurred. As an example, the refiltering of a buffer solution, where the post filter integrity test failed, may be allowed, but the net COGs would need to include the additional components, utilities, and labor required to reprocess the solution. The system integrity failure could also require additional future testing and revalidation of the process, which consume additional resources.In order to minimize defects and associated costs, the process should be highly robust and repeatable, such that any OOS product is identified immediately. Line tours and process observations can provide good information and insight into the causes leading to defective products. Statistical techniques like Pareto Analysis can be used to identify those processes, equipment, or procedures which cause the highest number of defective (or OOS) products. Data mining techniques and Analysis of Variation (ANOVA) can be used to understand relationships between various factors that generate defects and help to determine the root causes.

32 ENGINE ASSMBLY

Characteristics of Hidden lossesThough hidden losses differ by products, processes, facilities, etc., there are some common traits that are observed:

Hidden losses irrespective of type, negatively impacts productivity, flexibility, and profitability.

Losses will not be always “visible.” Obvious waste is easy to reduce/eliminate. However, it is the unseen waste that poses the real threat. This type of waste needs to be identified and eliminated.

Losses can be concealed even in the (so-called) value added activities.

Losses are not always independent of each other. One type of losses can lead to another, e.g., overproduction could increase chances of defects, increase inventory, transportation, etc.

Some NVA activities are miscategorized as ENVA activities. Some are due to legacy practices no longer applicable with the use of new technologies and better process understanding. Proper identification of Critical Quality Attributes will lead to a lean Quality Program based on risk to patient.

Tools and Techniques Used in Waste Reduction Efforts

33 ENGINE ASSMBLY

Using the right tools and techniques can help identify, and subsequently reduce (or eliminate), waste from the process. Selection of an appropriate tool/technique is dependent on the problem at hand. Numerous tools and techniques can be employed for the aforementioned purpose. However, we will restrict the discussion to some of the popular techniques used for waste reduction.A common and most popular lean technique to identify waste is Value Stream Mapping (VSM). A value stream map is more than a flow chart. Using unique symbols, it shows both information and material flow, while capturing VA and NVA activities and their respective durations. This tool is used not only to depict current process, but also can be used to create a vision of future state processes. However, VSM does not capture the impact of variability on a process. Also, it cannot be used to understand the dynamic interactions that occur within the process.Modeling and simulation can be used to address such shortcomings. Discrete Event Simulations (DES) is very effective in handling variability and interactions. The ability to model random (stochastic) events, e.g., equipment failures, unavailability of resources, unexpected changes in demand, etc., allows DES to mimic the real world operations. DES is often employed to study “what-if” scenarios and to optimize a process or facility. Numerous commercial simulation software is now available, including Flexsim, Remodel, Arena, etc.Workplace organization using visual techniques also are recommended to reduce waste. Markings, colors, and other visual controls can be used to eliminate excess motion or inventory. Techniques such as 5S, visual production control, e.g., Kanban, and

34 ENGINE ASSMBLY

visual information and performance measurement techniques should be employed. Replacing manual operations with automated operations, wherever feasible, will reduce the errors caused by human intervention.Standardizing equipment, practice, and procedures can significantly reduce wastes. In many instances, standardization improves overall flexibility. Statistical and quality techniques, such as Design of Experiments (DOE), control charts, sampling plans, etc., can be effectively used to reduce waste in a process and even within supply chains.

Investigation and Prevention of Hidden Losses

35 ENGINE ASSMBLY

Issue 1 At head cover sealant application when head cover is fitted in engine sealant are fall outside the engine and create problems on other stages also some amount of sealant are waste. Currently 12gm sealant used.

Solutions: If we reduce pressure from nozzle and also decrease amount of sealant then these problems can be eliminated.

Issue 2 When engine model are change at RH crank case clamping one extra manpower required for adjusting the fixture bolt and that NVA take some extra time and manpower. That activities perform one full revolution of conveyor belt.

Issue 3 Stock of engine that is an inventory but it’s helpful for dispatching engine when engine are not assembled by assembly line. But it’s also a problem as well as covered more area at outside the assembly shop.

CONCLUSIONS:

36 ENGINE ASSMBLY

In this study, a comprehensive analysis of all cost elements which contributes to the quality of products and services in the supply chain line of a manufacturing firm has been conducted. Apart from the normal prevention-appraisal-failure mode quality cost categories, more in depth analysis of all activities in the whole supply chain is done to track and measure the hidden elements of quality cost including the opportunity cost elements.The study is findings points out the fact that the hidden cost of quality is more than 3 times higher than the direct quality cost elements in the manufacturing firm and most of these hidden costs can be reduced or even eliminated by proper tracking and understanding the root causes. This study highlights the inadequacy of traditional cost of quality system in tracking and assessing the overall costs of quality. In order to assess the overall cost of quality, the hidden costs also has to be identified, quantified, measured and analyzed. For tracing the hidden quality costs, it is necessary to move beyond the data produced by the traditional accounting system. This also gives an insight to the huge impact of hidden quality costs to the organizational bottom line and points out the gold mine of improvements. Using this data the company can formulate survival strategies in the highly intensive competitive market scenario. Future studies in this field are recommended with the study of impacts of hidden elements on overall quality cost and development of a quality cost expert system with inclusion of hidden and opportunity cost elements.As pressure to cut costs continues to grow, companies need to reflect on their current practices and identify any possible sources of waste. Lean and Six Sigma methodologies can be used to help identify non value adding activities and eliminate the causes of waste, along with variability in supply, demand, or processing.

37 ENGINE ASSMBLY

Overcoming the initial hurdle of admitting a process is not perfect can be the hardest part. There is a perceived high cost to re-validate a process. Many times, the benefits gained from process improvements can overcome the cost of re-validation within the first year. The savings can be realized as increased capacity or reduced inventory in a warehouse. The benefits are not limited to cost savings, but may include quality improvements and increased flexibility.

38 ENGINE ASSMBLY

THANK YOU

39

ENGINE ASSMBLY