Reliance Implementation Methods Applied to a Kaizen Project




(1)
Department of Neurology, Wake Forest University School of Medicine, Winston-Salem, NC, USA

 



Abstract

Reliance industries limited (RIL) owns and operates the world’s largest Greenfield oil refinery complex in Jamnagar, India. While traditional oil refineries take between 6 and 8 years to build and operate, the Jamnagar refineries were built in record time in 3 years per phase. Reliance Industries uses a unique set of practices to prevent cost and time overruns and achieve project completion ahead of time. These hold unique opportunities which can be implemented in day-to-day clinical medicine. In this chapter, we describe the use of Reliance methods to transform the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP). The Japanese word Kaizen stands for continuous improvement and was introduced in Chap. 8. This chapter implements a Kaizen project using Reliance methods for the treatment of CIDP to improve the limitations of traditional methods.



An Introduction to Reliance Industries Limited


Reliance Industries Limited (RIL), based in Mumbai, India, is ranked 99 in the Fortune 500 global list of the world’s largest companies by revenue [1]. Reliance Industries was founded by Mr. Dhirubhai Ambani as a textile company and has since grown to become a large conglomerate with interests in petrochemicals, oil refining and exploration, retail, infrastructure, and life sciences. Reliance’s entry into any business is transformative of that landscape; the company thrives on the challenge posed by an over-ambitious, mega scale project which has not been implemented anywhere in the world before. A study of all of Reliance’s businesses is too vast to be covered in a book chapter; therefore this chapter borrows methods from RIL’s crown jewel—Jamnagar Refineries, located in Jamnagar, in the western Indian state of Gujarat. RIL’s Jamnagar refinery, built in two phases at a total capital cost of $16 billion, is the largest Greenfield refinery in the world with a refining capacity of approximately 1.3 million barrels per day. For the 2011–2012 period, RIL’s refining business processed 67.6 million tons of crude with a capacity utilization rate of 109 % and exported $36 billion worth of refined products. RIL’s gross refining margins (GRM) are among the highest in the world and stood at $9.5/barrel at the time of writing this chapter. This chapter is limited to the study of a few extremely useful project implementation tools which are part of RIL’s management methodologies for application in medicine and neurology.


Reliance Project Implementation Methods


Reliance blends a core management philosophy with a continuously refined business process which is common across a range of businesses. The following management methods were learnt from RIL and find valuable application in project implementation in clinical medicine. We explore concepts of Microplanning and Backwards Integration which have applications in clinical medicine.


Reliance “Microplanning”


At the heart of all successful Reliance projects lies a concept called “microplanning”. Reliance performs highly detailed analysis of every project prior to implementation which requires an in-depth understanding of complexity, processes, resources, challenges, redundancies, and potential disruptions involved. Once such a detailed project plan is made which incorporates all these elements, unforeseen complications are few and time and cost overruns are naturally prevented. Falling behind schedule happens only when the project is not well planned into strictly controlled processes. Microplanning is conceptually very similar to the “Detailed Design” block in the systems engineering V shown in Fig. 7.​1 of Chap. 7.

Microplanning is applied extensively by all employees across all Reliance businesses. At its heart, microplan involves setting a clear goal and establishing well-defined intermediate steps or micro-milestones leading to that goal. Each intermediate step is understood as a process which needs to be optimized both individually and in relation to all other processes that are connected to it. To the extent possible, intermediate processes required for the final goal are implemented in parallel to minimize overall process time. If any intermediate step of the process interferes with other processes, accommodations are made to both processes to minimize disruptions and interference. Once intermediate steps and processes are identified, processing times and costs for each intermediate step can be benchmarked. Once this is done, potential reconfigurations of the process sequence and stepwise innovation can be implemented. This enables accurate estimation of cost, time, implementation challenges, and prevents overruns since the original estimates have factored in all these elements. Microplanning is practiced not just with regard to projects implemented by Reliance employees but with vendors as well. This is partly why relationships with vendors are so close, so as to understand their capabilities, resources, limitations, and processes to accurately predict their success with the project. RIL’s microplanning method involves making alternative plans and creating redundancies for any task to manage unforeseen complications. This is the management equivalent of fault tolerance.

Microplanning enables measurement since intermediate processes are well-defined which helps with forecasting and innovation, both for the project on hand and with the global enterprise. Consider the following example of buying and installing a large prefabricated equipment for a particular refinery process (such as a boiler). Microplanning involves the following major steps and implementation:

1.

Identify requirements and arrive at specifications. Identify manpower requirements, project ownership, and decision making responsibilities.

 

2.

Identify supplier/technology partner.

 

3.

Finalize orders—costs, delivery time frames.

 

4.

Specify milestones for product development from vendor—fabrication, electrical/control system installation milestones, testing milestones.

 

5.

Station Reliance employees at vendor fabrication facilities to monitor progress, understand technology, and provide close feedback to future operating group on equipment. Monitor progress and verify stated progress made by vendor.

 

6.

Specify exact shipment times when product is ready to leave vendor’s facilities.

 

7.

Identify shipping requirements and book cargo space on large cargo carriers months in advance.

 

8.

Identify loading/unloading requirements—the size, lift capacity of crane to unload cargo. Reserve lifting capacity for specific cargo based on exact arrival times from shipping company.

 

9.

Obtain regulatory clearances to expedite customs.

 

10.

Identify land transportation requirements—what road to take from the docks to the installation site which can handle such oversized cargo. Reserve appropriate trucks, loading/unloading cranes at required times.

 

11.

Identify and train installation technicians at the onset—how to install the equipment correctly.

 

12.

Identify and train technicians using simulators, product literature etc. for operation of the machinery.

 

13.

Invest in special infrastructure this project will need such as site preparation, heavy lift cranes, trucks, power requirements, piping, and industrial automation systems.

 

14.

Identify how this project and movement of such special oversized cargo would affect traffic and materials delivery for neighboring processes. For example, if a nearby worksite accessible only by the same road is involved in building a concrete structure on the same day as this cargo will be transported slowly by special movers which will block the road to the worksite, provide advance notice of potential disruption of their supply chain so that they have reserve construction materials (cement, steel, brick, etc.) to prevent disruption of that process.

 

15.

At all levels of the process, invest in safety infrastructure for the equipment.

 

16.

Based on above, identify the target completion date when the equipment will be functional and work backwards to set dates and times for intermediate milestones.

 

For the example above, microplanning therefore enables a solutions-based approach instead of just installing the equipment. It breaks an overall plan into small intermediate steps to visualize work flow with strict metrics between steps. This ensures a process stays on track without cascading delays. The project is viewed not just from construction, installation perspectives, but it is integrated with training, safety, and specifications of remote processes which may be influenced by it. For the example above, if the equipment weighs 100 t, at the outset itself it enforces load requirements on the roads required for transporting this equipment and size and strength of the jetty for unloading this cargo. It enables a global view—how does this process interfere with others and what steps can be taken to minimize such disruptions or enhance synergies? Once these intermediate tasks are identified, costs and time frames can be accurately estimated and contingency planning—such as weather-related disruptions—performed. Paradoxically enough, a micro-view enables a holistic approach and possibly prevents expensive reengineering of linked processes.

Once the microplan is ready, processes with long lead times can be identified. In this case, the construction of the equipment itself is perhaps the rate determining step with the longest lead time from conception to delivery. Construction of the appropriate size jetty, road, heavy lift cranes, transportation trucks, electrical/piping requirements are others. This must, however, be done in parallel at the outset itself; otherwise implementation of the primary objective will be delayed. Personnel required for operation of the equipment must be hired, adequately trained well before delivery to enable error-free immediate operation once installation is complete. This too needs to be done in parallel, perhaps halfway along the way. This can be represented graphically as a flowchart for better data visualization, project management, and road map planning. Predicted dates for completion of intermediate milestones can be mapped onto the flowchart and the microplan shared with all members of the implementation team ranging from equipment vendors to construction personnel. Microplanning therefore requires close teamwork, high quality communication with all members of the project team, and with interrelated processes to be successful. Microplan is also related to checklists discussed in Chap. 7.

Since microplanning maps intermediate steps so well, it lends itself well to measurement and improvement in the form of kaizen. It enables targeted investments in process improvement and improving efficiency to be made. An example narrated by Reliance’s master builder involves speeding up the time for hardening and drying concrete. The microplan for construction allocated 3 weeks for this step during phase 1. During phase 2, innovations in this step were identified in the form of additives which speed up drying time. This speeded up the process to 12 days instead of 21 days during the construction of phase 2 [2]. Construction microplans were then updated to reflect this development and adjust downstream processes to exploit this breakthrough.

A personal experience with microplanning would enhance appreciation of the utility of this principle. My visit to the Jamnagar refineries was implemented using a visit “microplan”. The microplan was based on the following principles:

1.

First identify the objectives of the book and the knowledge to be gained from Reliance. These were understood to be construction, operations, and management.

 

2.

Identify the key personnel involved and contact them for the assistance they may be able to render. Email them the objectives of the book and request them for ideas and experience (such as microplanning, project integration) which may be useful. Request them to compile their ideas and contributions for a meeting.

 

3.

Schedule appointments in Mumbai and Jamnagar with all relevant personnel.

 

4.

Arrange a tour of the complex to appreciate the scale first hand.

 

During my visit to Jamnagar, I met executives from these departments and human resources together in the refinery conference room. The microplan was implemented in this manner because:

(a)

I would not have to repeat myself and the book objectives to each executive I met, thus spending 15 min in introduction with each person. An opening statement addressed to all the executives together would suffice to introduce the subject.

 

(b)

Repetition would be avoided—two people would not proceed to narrate the same thing.

 

(c)

Ideas could be integrated between different operating groups. For example, construction and human resources involved great synergy since construction engineers described the great productivity they achieved from a motivated labor force due to progressive human resources management.

 

(d)

Time would not be wasted in going from one office to the other in a vast refining complex.

 

The visit was planned down to the minute of departure from the refinery to arrive in time for our return flight back to Mumbai from the nearby town of Rajkot 130 km away. The microplan had made allowance for traffic disruptions should the highway be blocked by an accident on the way. This simple example shows how microplanning can be applied to any matter for efficient implementation.


Backwards Integration


Mr. Dhirubhai Ambani started his business in India manufacturing textiles under the Vimal brand name. Focusing on polyester-blended clothing, the business was a huge success with booming demand for durable, easy to maintain, affordable synthetic fabric. The hypothesis he posed was that since polyester is the main feedstock for the textile business, manufacturing polyester and integrating it with downstream textile manufacturing would have competitive advantages and synergies for both. For the new venture into raw material, the risk is mitigated to some extent by the captive market from the existing business thus hedging the venture to some extent. In short order, Reliance came to dominate manufacture of polyester and synthetic fabric in India and spawned a globally competitive petrochemical industry. Extending this concept backwards, since oil products are the feedstock for the petrochemical industry, Reliance expanded into the oil refining industry. Finally, since the main cost of oil refining is crude oil itself, Reliance completed the process by entering the oil exploration business with successful crude oil and gas drilling in the KG-D6 field in India. This is called backwards integration, when a company progressively expands into earlier steps of its manufacturing chain.

Microplanning and backwards integration play extremely useful roles in clinical medicine as will be shown in the following sections. Following a visit to the Jamnagar Refineries, these were applied in great detail to day-to-day clinical neurology.


CIDP: The Traditional Way of Doing Things



Case Example 1


DS is a 53-year-old woman who presented to an outside hospital with rapidly progressive weakness and numbness which started in her feet and ascended to involve her arms in Feb–March 2012. Over the course of a few days, DS became quadriplegic and bedridden requiring assistance for everything from feeding to turning in bed. She was correctly diagnosed at the outside institution with acute inflammatory demyelinating polyneuropathy (AIDP), also called Guillain-Barré Syndrome. She was transferred for further treatment.

Following treatment with five sessions of plasmapheresis, she made the anticipated modest improvements followed by admission to inpatient rehabilitation. After spending 3–4 weeks in rehab, she developed recurrent symptoms which were felt to be related to her original GBS. She was treated again with plasmapheresis and discharged to rehab with the same degree of improvement. She was seen by the author another 4 weeks later with progressive deterioration, now a full 8 weeks from initial onset of symptoms. During the course of her illness, IVIG was attempted once, but it led to stroke-like symptoms which fortunately resolved after stopping infusion of the drug. This led to discovery of an asymptomatic right-sided carotid artery occlusion which made future use of IVIG risky because of its tendency to elevate the stroke risk.

The recurrent severe episodes had one interesting feature in common—while they involved all the limb muscles severely weakening the arms and legs, they never involved respiratory muscles or swallowing muscles. This is somewhat unusual for GBS since many people with severe illness will have some degree of respiratory and swallowing involvement. An alternative hypothesis was whether this was chronic inflammatory demyelinating polyneuropathy (CIDP), which has a similar profile but never involves the breathing or swallowing muscles. CIDP is steroid-responsive. Steroids form the third choice for treating CIDP along with plasmapheresis and IVIG [3].

After her third relapse, a tentative diagnosis of CIDP was made and treatment initiated with steroids concurrently with plasmapheresis. The lack of ocular, bulbar, autonomic, ventilatory involvement despite quadriparesis favored CIDP over AIDP. Further she had experienced over 8 weeks of recurrent nerve problems. The hope was plasmapheresis would filter out the circulating antibodies and the steroids would suppress the immune system to stop their manufacture. DS had a good response to plasmapheresis and unlike the last two times, this time the response was sustained and better than she had experienced with plasmapheresis alone. DS was happily discharged to rehab in much better shape than she had ever been with an introduction to the new treatment plan which was to do long-term therapy with steroids for treatment of CIDP. Plasmapheresis would be reinitiated if there were any setbacks along the way and IVIG was rejected as being too risky due to the high stroke risk from the right carotid occlusion. The carotid occlusion was defined as a second problem and was treated according to standard guidelines with aspirin and atorvastatin 80 mg/day.

DS would spend 2 months in rehab before being seen in clinic. She had no relapses, continued to make steady progress with rapid progress to standing and walking with assistance and gross hand movements. The patient and physicians were delighted with this progress; the PLAN had worked and a slow taper of steroids was started to reduce side effects from prolonged high-dose steroid treatment. Weight gain, a frequent side effect of steroids was observed and patient counseled about “watching her diet”. Bone loss and fracture of a vertebra were observed despite standard precautions (calcium, vitamin D); fortunately this did not need spine surgery or cause instability. She was also asked to follow-up closely with her primary care physician for “general medical conditions”. Over the next 4 months, the dose of prednisone was tapered from 40 mg to 20 mg/day with durable benefit in her CIDP. She regained full strength in her proximal upper and lower extremity muscles, but continued to suffer from intrinsic hand muscle weakness and foot drops. Painful paresthesiae continued to require Gabapentin for pain relief.

In September 2012, a chance phone call to check on her well-being found her very confused and lethargic. An immediate evaluation in the emergency room led to discovery of severe dehydration, urinary tract infection, a blood sugar of 800 mg/dL (normal <150 mg/dL), and severe electrolyte abnormalities. Since these are all systemic side effects of steroids, the dose was reduced further since the nerves were 90 % back to normal in terms of strength and functionality and the side effects were greater than anticipated benefit. “Fault containment” was initiated with immediate assistance requested from orthopedics for a vertebral compression fracture and internal medicine endocrinology since controlling the blood glucose level was a significant challenge for the non-specialist. Given this plethora of complications, prednisone was tapered and discontinued over 3 weeks. Over the next 4 weeks, each side effect required the assistance of specialists—endocrine, orthopedics, and internal medicine across two medical centers.

Fortunately, 1 year later she returned to work full time, made a sustained, durable recovery and at the time of her last examination in May 2014 had no weakness. She continued to suffer from moderate painful paresthesias which were responsive to Gabapentin. We analyzed the complications she experienced. She had heard the speech about reducing calories, checking sugars and blood pressures, but somehow it was never followed through and never implemented. It was lost somewhere in her transition from hospital to rehab to home. The physician stuck to the PLAN, which was how best to suppress the immune system for a durable response which would prevent worsening and prevent need for rescue therapy with plasmapheresis. The PLAN was successful, but the implementation was not. A careful analysis revealed that most of the side effects could have been prevented. The fact that she had a near cure from a relapsing remitting disease, however, presented a remarkable opportunity and begged the question—how can this be done better?


Kaizen: CIDP Treatment Implemented Using Reliance Microplanning


Following the experience with case Example 1, treatment of CIDP was implemented using Reliance microplanning. The following CIDP Microplan was defined and implemented.

1.

Mission Objectives.

1.1.

Dependable treatment of CIDP (meeting all criteria for dependability).

 

1.2.

Establish specific Success and Failure objectives (see Fig. 9.1).

A327463_1_En_9_Fig1_HTML.gif


Fig. 9.1
Defining success and failure. Source: NASA [4]

 

 

2.

Diagnostic Confirmation.

2.1.

Confirm Clinical, CSF, and Nerve corroboration.

 

2.2.

Approach problem in Byzantine framework. (See Chap. 6)

 

 

3.

Perform Preliminary System Safety Assessment (PSSA) followed by System Safety Assessment (SSA):

3.1.

Identify specific individual safety concerns and mitigation strategies. (See Chap. 2)

 

3.2.

Implement “defense in depth” for identified risks.

 

3.3.

The process includes FHA, FMEA, and mitigation strategies described in prior chapters.

 

 

4.

Check Immunosuppression Checklist to identify risks prior to immunosuppression. (See Chap. 7)

 

5.

Use Steroid and IV Methylprednisolone Failure Modes and Effects Analysis (FMEA). (See Chap. 4)

 

6.

Use Steroid Nutrition Information. (See Appendix)

 

7.

Implement Plan Do Study Act Cycles. (See Chap. 8)

7.1.

Establish micromilestones.

 

7.2.

Monitor implementation.

 

7.3.

Perform shortfall analysis.

 

 

8.

Collect data for continued improvement. (See Chap. 7)

 

The principles behind each of these steps have been discussed in detail in appropriate chapters referred to in the right column. A few additional aspects are discussed here. Step 1, establishing mission objectives, defining success, and failure is extremely important since this is a disease which is best treated in partnership with the patient. Figure 9.1 is a useful framework for defining success and failure borrowed from NASA.

For the case of CIDP, given its variable response to treatment, based on Fig. 9.1, the following success and failure conditions were defined to guide treatment (Table 9.1).


Table 9.1
Defining success and failure conditions for treatment of CIDP






















Success space

Failure space

Total success: Clinical remission with or without maintenance Rx. Independent ambulation, little or no numbness and pain

Minimum anticipated failure: Residual toe weakness, dropped great toe. Mild pain and numbness. Side effects: <10 lbs weight gain, cataract, osteopenia, hair loss

Maximum anticipated success: Ongoing Rx. Walk with three or four pronged cane. Distal weakness, AFO’s, Mild to moderate pain not needing opioids, numbness

Maximum anticipated failure: Mild to moderate permanent foot drop, numbness, painful paresthesias. Side effects: Above, plus: HTN, >10 lbs weight gain, osteoporosis, moderate Diabetes mellitus

Minimum anticipated success: Ongoing Rx. Walk with walker. Moderate pain needing opioids, multiple pain medicines, severe numbness

Maximum tolerable failure: Able to stand with walker. Side effects: Above, plus Cushing Syndrome. Severe diabetes mellitus

Minimum acceptable success: Ongoing Rx. Unchanged strength. Moderate pain relief, severe numbness

Complete failure: worsening hand symptoms. Side effects: Above, plus Cushing Syndrome. Vertebral compression fractures. Severe diabetes mellitus. Other organ complications without benefit: example Stroke/DVT/PE from IVIG


Adapted from Fig. 9.1

Defense in depth strategy (see Fig. 1.​7, Chap. 1) was implemented for many aspects including blood pressure control (Table 9.2).


Table 9.2
Defense in depth for management of blood pressure






















Numerical range

Intervention

Nominal set limit: 150/90

No action needed

Allowable limit: 160/95

Monitor closely day of infusion. Provide prescription for Amlodipine 5 mg/day

Analysis limit: 170/100

Hold infusion. Start anti-hypertensive therapy: Lisinopril/HCTZ, Metoprolol

Safety limit: 180/110

As above, but send patient to ER/PCP for close monitoring


Case Examples of Kaizen Using the CIDP Microplan


Following the experience with patient DS in case Example 3.1, the following patients were treated using the CIDP microplan. It should be noted that the microplan was lacking step 6, steroid nutrition information sheet was not prepared and implemented till case Example 5.


Case Example 2


LM is a 66-year-old male who presents for evaluation of leg weakness and numbness. This started approximately 8 months ago, but progressed to the point that he could barely walk. Symptoms started with right hip pain for which he received two steroid injections. After the injections he noticed burning pain in his thighs. He then began developing difficulty with balance and walking. The legs started getting weak more recently. The burning pain worsened and progressed to involve both arms, torso, and worsened in his thighs. He denied any facial involvement. He had some mild problems with swallowing and feels like his voice isn’t as strong as it was. He can’t cough as strong as he could before. He had some constipation and urinary frequency. Past medical history includes hypertension, diabetes mellitus which are controlled with diet and exercise and low back pain. He was on Fentanyl patch for relief of pain.

On examination: Weight: 251.0 lbs. BP: 102/68, Pulse: 73. Mental status was normal. Cranial nerve examination was normal save gaze-evoked nystagmus. Motor examination revealed normal proximal upper extremity strength. The hand intrinsics showed moderate weakness being approximately 4/5 bilaterally. In the lower extremities, hip flexors were 4/5 bilaterally. There was considerable weakness of dorsiflexion being 4-/5 bilaterally. Deep tendon reflexes were 1+ at bilateral biceps, brachioradialis, and absent elsewhere. Sensory exam revealed decreased sensation in stocking glove distribution to all modalities. Romberg was positive and routine gait was very unsteady and stooped forward. Patient needed a walker to stand and walk.

A nerve conduction/EMG was performed which showed the findings in Table 9.3.


Table 9.3
NCS/EMG findings for case Example 2


























































































































Nerve and side

Latency (ms)

Distance

Amplitude (mV)

Velocity (m/s)

F waves (ms)

Peroneal and tibial motor (Right)

Absent
       

Peroneal motor to Tib. Ant. (Right) Fibular Head

4.2

80 mm

1.4 (>2 mV)
   

Popliteal Fossa

7.1

1.2

34 (>41 m/s)

Median motor (Left) Wrist

5.0 (<4.4 ms)

70 mm

5.1 (>4 mV)
 
36.4 (<31 ms)

Elbow

10.3

4.8

47 (>49 m/s)

Ulnar motor (Left) Wrist

4.0 (<3.5 ms)

70 mm

1.3 (>6 mV)
 
36.3 (<32 ms)

Below Elbow

10.4

0.3

32 (>49 m/s)

Above Elbow

14.7

0.2

31

Ulnar motor (Right) Wrist

4.0 (<3.5 ms)

70 mm

3.4 (>6 mV)
   

Below Elbow

10.7

0.8

33 (>49 m/s)

41.1 (<32 ms)

Above Elbow

14.4

0.8

38

Sural, ulnar sensory

Absent
       

Median sensory (Left)

3.5 (<3.5 ms)
 
8 (μV) (<22 μV)
   

Muscle and side

EMG findings

Tib. Ant. (Right)

Profuse fibrillations and positive sharp waves. Motor units showed increased amplitude and duration, polyphasia with reduced recruitment

Medial gastric (Right)

Moderate fibrillations and positive sharp waves. Motor units showed increased amplitude and duration, polyphasia with normal recruitment

Vastus lateralis (Right)

Absent spontaneous activity. Motor units showed mildly increased amplitude, duration, polyphasia and normal recruitment

Tensor Fasciae Latae (TFL), L5 paraspinal (Right)

Normal

First Dorsal Interosseous (FDI) Right

Moderate fibrillations and positive sharp waves. Normal motor units with reduced recruitment

Extensor Digitorum Communis (EDC), Triceps, Right

Normal

T8 Paraspinals (Right)

Mild fibrillations and positive sharp waves


Standard normative data are presented in brackets

Based on EMG findings in Table 9.3 (forearm conduction blocks involving the ulnar motor responses, slow conduction velocities, prolonged F waves), LM was diagnosed with CIDP. An MRI Brain was performed since he reported some swallowing difficulties and had nystagmus. This showed a large right-sided, vestibular schwannoma as an incidental finding. Since he had an intracranial mass, CSF studies were not performed. Supporting lab work showed ESR 17, CRP 0.6, normal CMP with glucose of 102 mg/dL, CBC: Hb 12.5 g/dL, WBC 6.6 and Plaletets: 178. TSH: 2.938; Serum and Urine Immunofixation were normal.

LM was treated using the CIDP Microplan, save the steroid nutrition sheet which had not been prepared at the time. The microplan yielded the following (Specific patient information is entered in italics):

1.

Mission Objectives.

1.1.

Dependable treatment of CIDP (meeting all criteria for dependability).

 

1.2.

Establish specific Success and Failure objectives: Success objectives:

(a)

The constant whole body pain was the most distressing aspect of his presentation. Therefore, the first mission objective was relief of pain.

 

(b)

Improve weakness in legs, ability to walk, and balance.

 


Failure Space:

(a)

Worsening pain.

 

(b)

Worsening lower extremity weakness needing wheelchair confinement.

 

(c)

Worsening hand weakness.

 

 

 

2.

Diagnostic Confirmation.

2.1.

Confirm Clinical, CSF, and EMG Data.

 

2.1:

Confirmed.

 

2.2

Approach problem in Byzantine framework. (See Chap. 6)

 

2.2.

Problem was cast in a Byzantine generals framework for corroboration. Clinical, EMG data corroborate. CSF could not be obtained.

 

 

3.

Perform Preliminary System Safety Assessment (PSSA), SSA: (See Chap. 2)

3.1

Identify specific individual safety concerns and mitigation strategies.

 

3.1:

PSSA performed: The following risks were identified: borderline diabetes mellitus, borderline hypertension: Category: Minor.

 

3.2.

Implement “defense in depth” for identified risks.

3.2.1.

Defense in depth for hypertension implemented using Table 9.2.

 

3.2.2.

Defense in depth for diabetes mellitus: Check blood glucose at home periodically. Request close follow-up with primary care physician.

 

 

 

4.

Immunosuppression Checklist. (See Chap. 7)

4.1

No risks for immunosuppression identified.

 

 

5.

Steroid and IV Methylprednisolone Failure modes and effects analysis (FMEA). (See Chap. 4)

5.1.

Refer FMEA for IV Methylprednisolone, Chap. 2.

 

 

6.

Steroid Nutrition Information. (See Appendix)

6.1.

Not implemented at the time.

 

 

Sep 24, 2016 | Posted by in NEUROLOGY | Comments Off on Reliance Implementation Methods Applied to a Kaizen Project

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