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Planning Supervisor

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Submitted By MahmudAtta
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• Market studies identified new opportunity, which will increase company market share for central venous catheter product by 10 % profit. Introduction about central venous catheter
• Heart block and arrhythmia are complications of pulmonary artery and cardiac

catheterization. Injury to the conducting system of the heart often involves the right bundle causing right bundle branch block (RBBB). If patients already have left bundle branch block (LBBB), complete heart block (CHB) may result. After trauma, impairment of the right bundle is usually transient with recovery in hours, but complete heart block can lead to symptoms requiring invasive treatment. Similar complications are rare with insertion of central venous catheters, as they should not enter the heart. Injury to the right bundle during central venous catheter insertion can be by trauma from the guide wire or from the catheter itself. The function of the AV node and bundle of His in these patients has not been studied before. We report a patient with LBBB who developed CHB during insertion of a central venous cannula. Conduction through the AV node and His–Purkinje system was intact, showing that the transient RBBB was caused by traumatic injury rather than by other disease of the conduction system.

Designing central venous catheter product, which will appeal customer who are looking for a quality, healthy, sterility, and pyrogen free. The new product should be on shelf in test markets within nine months of start of the project and meet following goals.

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Team members: Mahmud Abu el-Atta Mohamed Elmorsy Hamada Sharaf Amr Abdel Aziz Ismail El Hamalawy Maged Hamdy Emad Ali Production Planning specialist Quality assurance specialist Production manager Quality control lab Purchasing manager Operations Warehouse manager

The mission goals meet the five criteria of SMART method:
S (specific) A guide wire specific for cardiac heart attack and for kidney failure patients. Achieve 30% market share in its category within two years after implementation of the plan. Reasonable price for middle and first class categories of people. Generate at least 8 million L.E in sales, during the first 12 months after introduction and grow to provide revenue of 12 million L.E from sales by year three. Provide Gross profit (after selling expenses, but before general and administrative expenses and taxes) of 15 percent during its second 12 months after introduction. The product well sell at the same 10 Export Markets to provide at least 30% of the sales after 2 years of introduction A (agreed upon) R (realistic) T (time framed) Customer requirements. According to feasibility & medical studies. Ready for registration in Ministry of health September 2008 and ready for mass production and selling on October 2008

M (measurable)

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Tree Diagram:

List customers and prioritize Identify customers Great flow diagram

Survey/interview key customer Discover customer needs Conduct more data collection Complete needs analysis

Design / test question

List single dimension needs Translate needs Develop units of measure and sensors

Design for central venous catheter
Develop product

Develop features and goals Set and publish final product design

Product features spread sheet Product design spread sheet

Collect information on alternative processes Develop process Develop features and goals Develop high-level process design

Develop process controls/Transfer to operation

Great process control sheet

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start Marketing requirement Designer Packaging material planner Purchase Warehouse Analytical Lab. testing Acceptance of raw materials and packaging materials Production and packaging Approval by MOH Warehouse Final approval by QA QA to prepare related documents

Order Raw material

Distribution branches

Pharmacies

Hospitals

Wholesalers

End user

end

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Internal Customers
Purchasing Production Quality control lab Market team Warehouse Compliance and Registration Planning Int. Distribution Branches Quality assurance

External Customers
Hospital Heart centers Shoppers Pharmacist Doctors Ministry of Health (MOH) Export markets External Distributors Raw material Suppliers Packaging material suppliers

We list the internal customer and prioritize them according to the most important customer to the least important one. Internal Customer
Purchasing Production Quality control lab Market team Warehouse Compliance and Registration Planning Int. Distribution Branches Quality assurance
 Major impact = 5,

Criteria
Cost 5 5 3 5 5 1 2 5 1 Customer satisfaction 5 5 3 5 3 3 5 5 5
Small impact = 1

Process 5 5 3 5 1 5 5 5 5

Total
15 15 9 15 9 9 12 15 11

Moderate impact = 3,

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Criteria Customer
Hospital Heart centers Shoppers Pharmacist Doctors Ministry of Health (MOH) Export markets External Distributor Raw material Suppliers Packaging material suppliers
 Major impact = 5,

Rates 5 1 5 5 3 5 5 5 3 1

SAL 1 3 3 5 5 5 5 5 5 3

Image 3 3 5 3 5 3 5 3 5 5

Delivery time 3 3 3 1 1 3 1 3 1 5

Special requirement 1 3 5 5 5 5 1 5 3 5

Total
13 13 21 19 19 21 17 21 17 19

Moderate impact = 3,

Small impact = 1

Vital few internal customers: 1. Purchasing 3. Market team 5. Planning Vital few external customers: 1. Shoppers 3. External distributers 5. Doctors 7. Export markets 2. Ministry of Health (MOH) 4. Pharmacists 6. Packaging material suppliers 8. Raw material suppliers 2. Production 4. Int. distribution branches 6. Quality assurance

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A. Sources and methods team will use to identify the needs of external customers: 1234Customer surveys focus groups and market research programs and studies. Tracking customer complaints, incident reports, letters and telephone contacts. Routine communications such as sales and management reviews. Employees with special knowledge of the customer sales, service, clerical supervisory, who come in contact with the customers. 5- Hold customer meetings. 6- Hold user conferences for the end user. 7- Information about competitors’ products. B. Sources and methods team will use to identify the needs of internal customers: 1- Hold meetings with some of the important internal customers' example production, sales and marketing. 2- Design data collection. 3- Create action plan and a planning network for data collection. 4- Collect a list of customers' needs in their language. - External Customer: Sample questionnaire for Doctors and pharmacists:           What do you expect from a central venous catheter product? What is unexpected from a new central venous catheter formula? What do you recommend taking in consideration during design of the product? How can central venous catheter products support treatment of some common diseases? How can dose be designed in your opinion? In your opinion, are their specific elements that should be added? In your opinion, are their specific untraditional elements that can be added to the product? How far can the pack design affect users/patients? How can this product be the best selling one in the market? What do you like best in current products in the market?

Sample questionnaire for Shoppers:  What is most important for you when you seek for a central venous catheter?  What do you do you think about a central venous catheter product quality?  How can you overcome resistance of you to take central venous catheter from company?
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   

How would you expect us to overcome such resistance? What were the drawbacks of the central venous catheter you used before? What is your opinion about our company image in medical market? What is the support and after sales service, that you expect from our company and you didn't get?

We have conducted surveys with customer whom has the highest percentage of production and we filled out the below spreadsheet with customer need based on each customer segment. Customer Needs
Quality Design Packaging Price Delivery transit time Biocompat ibility Sterility Pyrogen free

Internal Customer

Purchasing Production Quality Assurance Market Team Planning Int. Distribution Branches Total need score

9 9 9 9 9 9 54

9 9 9 9 9 9 54

9 9 9 9 9 9 54

3 3 9 9 3 3 30

3 9 1 9 9 1 32

9 9 1 9 9 1 38

9 9 1 9 9 9 46

9 9 1 9 9 9 46

Legend 9 very strong 3 strong 1 Weak

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External Customer

Customer Needs
Quality Design Packaging Price Delivery transit time Biocompat ibility Sterility Pyrogen free

Shoppers Pharmacist Doctors Ministry of Health
(MOH).

9 9 9 9 9 9 9 9 72

9 9 9 9 9 9 9 9 72

9 3 3 9 3 9 3 3 42 12 3 3 3 3

1 1 1 9 1 1 1 1 16

9 3 3 3 9 9 9 9 54

9 9 9 9 9 9 9 9 72

9 9 9 9 9 9 9 9 72

Export markets External Distributors Raw material Suppliers Packaging material suppliers Total need score

Legend 9 very strong 3 strong 1 Weak

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Prioritization of internal & external customers need: 1. 2. 3. 4. 5. 6. Quality Design Packaging Sterility Pyrogen free Biocompatibility

Needs Analysis Spreadsheet Primary Needs Secondary Needs
Delivery without failure Packaging Price Delivery transit time 3- Sterility Pyrogen free

Tertiary Needs
Good preservation and handling. Packaging integrity is good Stored in locked safe Suitable price depending on the customer required design. On time Stored in locked safe Monitored Good preservation and handling after sale. Pyrogen limit of the finish product not more than 0.125 EU/ml.

1- Quality

2- Design

4- Packaging

Validation for the validation process. Low bioburden count during production process

5- Pyrogen free

6- Biocompatibility

Raw material biocompatibility study.

Finish product biocompatibility study

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List customers’ precise needs. Group related needs into clusters. Arrange the clusters in a priority listing for further analysis. Record on a work sheet.

 Benchmarking  Brainstorming  Basic research

Service Features Customer Needs/cluster
Quality Design Packaging Biocompatibility Sterility Pyrogen free
Low bioburden level High elasticity of wire Strong wire Coating material Medical paper Sterility assurance level less than 10-6

     
Comply with standard requirements

     
%

     
%

     
%

     
%

     
%

Goal

 very strong

 strong
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 Weak

Needs

Translation
- Sealing of packaging - Direction of wire - The component standard - Available of lengths - Suitable length is available - Resist degradation at 40°C - Component must be good

Units of Measure
According to inprocess inspection specification

Sensors
Conform with the product specification

Quality

Design

According to approved design from supplier

Conform to the product design.

Packaging

- Using hard cartoon boxes in shipping

Number of foreign material

Free from any foreign material

- Biocompatible with human Biocompatibility

Several tests depends on FDA and standard ISO 10993

Conform for human being

Sterility

- Free from microorganism

CFU
(colony forming unit)

Microbial count results for the product

Pyrogen free

- Free from endotoxin after sterilization

EU/ml

(this is the unit of measure)

Less than 0.125

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start Marketing require ments Quality Assurance create BOM Purchase raw materials for trials Contact suppliers Warehouse receive materials QC tests and approval Produce pilot batch Produce pilot batch Registration at M.O.H. Planning release order for production Purchase packaging materials

A

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A Contact suppliers Warehouse receive materials Sampled by QC
No

test
Yes

Warehouse to return to suppliers

Production department to start manufacturing
Rework No

QC testing

Yes

Start packaging Stores

Wholesalers Pharmacies End user

sales office (promotion)

End

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 Macro Processes  Sub Processes

Warehouse
Receive raw and packaging materials Sampling Adding materials to stocks Receive material dispensing order Dispensing materials to production Receive finished products from production Adding finished products to stocks Shipping product to Distributio n stores

Quality Assurance
Document Manufacturing and packaging procedures Monitoring production Sampling Review produced batch documentation Product release Receive and investigate complaints

Quality Control
Testing of raw material for production Testing of finished product samples Report certificate of Analysis Report out of specification

Production
Receive dispensed materials from warehouse Manufacturing Bulk Filling Packaging Transfer product to warehouse

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Shipping
Delivery of product to scientific office Delivery of product to different customers

Marketing
Market surveys Feasibility study Forecasting

Sales
Training of Medical and Sales representatives Visit Doctors and pharmacists Promotion Collect customers' orders

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Production process

Quality inspection process

Packaging and packing process

Environmenta l control process

Sterilization process

Product features
Low bioburden level High product elasticity Strong wire High quality coated material Medical wrap paper Wire dimension

     
%

     
Criteria for acceptance

     
%

     
Comply with standard requirement

     
%

 very strong

 strong

 Weak

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Control subject

Target

What
The product specification according to standard Prevent the occurrence of poison Comply with the customer specification

Who

When

Where

How

Action taken in case of deviation

Quality

Comply with the product specifications Free from any microorganisms Comply with the customer specifications

Production operators Microbiolog -ist Quality assurance

Every batch Every batch Every batch

Clean room

According to in process and final inspection specification complying According to British pharmacopoeia test method According to customer approval design

Rework

Sterility

Microbiology lab. Clean room

Rework

Design

Rework

Page 22

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