Case Study Review:

 

Operations - Continuous Process Improvement:

Date:                   October-09

Industry:             Operations/Manufacturing

Company Type:   Large Corporation

Employees:          800 at Site Location

Product:               Catheter

 

Service Need / Problem:

- Custom Orders; take loo long, cost too much, Customers dissatisfied with service.

 

Challenges:

- Large number of special SKUs

- Many different component parts, not always available

- Interfere with Main Production Line

- Order Taking Process Complicated

- Obsolescence issues

 

Considerations:

- Customer Service Concerns and Satisfaction

- System Constraints / ERP / Order Taking Process

- Importance to have "Specials"

- Cost Benefit to continue

- Importance to Business

 

Worked Performed /Accomplishments:

- Defined the Special Process by creating a "Process Map"

- Measured Lead Time of various specials

- Measured Actual Cost (this was unknown to the company)

- Performed Assembly Labor Studies and Analysis

Then -

- Constructed a revise Process Map, eliminating waste, improving flow

- Made Cost/Benefit decision to keep Specials SKU's

- Estimate cost and lead time with revised process

- Made collective decision to make changes and evaluate

 

Solution:

- Revise System - Order Taking Program/Screens

- Eliminate manual paper forms, routing, sign-off, and filing

- Convert to a paperless order taking system with e-approvals

- Create a separate "Specials" Product line that would not interfere with Main Line

- Create Kan-Bans, or "Queue" areas for main components used in Special Products

- Establish Inventory Safety Stock Levels

- Perform Pareto Analysis to decide on which SKUs to keep

 

Results:

- Shortened Lead Time

- Reduce Labor Cost

- Reduced Stock Out Situations

- Eliminated interruptions to Main Line (cost savings)

- Improved Customer Satisfaction

 

Learnings and Post Project Review:

- Seriously consider doing a Process Map; it really opens your eyes

- Poor Customer Service can easily lead to lost business - take action

- The "way it's always been done" is not always the right way now - things change

- Practice the Six-Sigma Methods of: DMAIC

  Define - Measure - Analyze - Improve Control

 

Quality/Manufacturing - Continuous Process Improvement:

Date:                   October-09

Industry:             Medical Device Mfg.

Company Type:   Large Corporation

Employees:          20,000 +

Product:               Inflation Device

 

Challenges:

- Reduce and/or Eliminate "Critical" Process Failure

- Identify Root-Cause

- Derive Potential Solutions

- Eliminate process issue without changing product design

- Provide corrective action without increasing product cost

 

Considerations:

- Customer Service

- Risk to End User

- Lead Time to Improve Process

- Project Expenses

- Capital Expenses

 

Worked Performed /Accomplishments:

- Performed Analysis of Process

- Identified Root-Cause (Adhesive Bond Failure)

  There were two Polycarbonate (PC) component parts that were attached to each other via

  a Adhesive Bond Process. A large number of potential process variable factors were identified: some of those

  included: amount of adhesive, placement location, risk of assembler error(no adhesive placed), humidity,

  cleanliness of parts, surface prep of parts, etc.

 

We could have worked towards a solution to all of the above, but in the end, would still be left with a Critical Process

to monitor with SPC and/or take the risk of a failure in the future.

 

Solution: we chose to eliminate the Critical Process entirely via application of Design-For-Manufacture (DFM)

principles and strategy.

 

We chose to combine these two component parts together into one homogeneous molded component, therefore

eliminating the Bonding process altogether. The components were changed, process eliminated, without changing

the form, fit, or function of the product design.

 

The new Injection Molded, one piece part was first evaluated through use of SLA models produced and tested

at low cost. This also gave sales/marketing an opportunity to review the new component and provide input.

 

A small Qualification was performed to confirm proper function, confidence/reliability, and to verify that there

was no change made to the overall Product performance.

 

Results:

- Eliminated Process Failure

- Eliminated risk of Assembler Error

- Eliminated the "Critical Process" itself

- Improved Customer Satisfaction

- Eliminated the Process Assembly Labor

- Eliminated Bonding supplies, tooling, etc

- Improved Assembler/Process Safety by eliminating bond adhesives

- Reduced part cost through new Injection Molded component

- Eliminated any chance of a Product Recall for this issue

 

Learnings and Post Project Review:

- Think "Out of the Box" - be creative

- Know your boundaries and required compliance restrictions

- Try to eliminate the real Root-Cause, not just add another band-aid

- Apply "Design-for-Manufacture" (DFM) Principles

- Apply Six-Sigma Methods

 

Do you have a Process Failure Issue?

Poor Yields?

Poor Quality?

High Costs?

Rework Issues?

Does your FMEA show High Risk?

 

Not enough resource to go around?

Unable to add another engineer headcount right now?

Don't have the In-House expertise?

 

SEND US AN EMAIL

GIVE US A CALL

CONSULTATION IS FREE

LET US SEE IF WE CAN HELP

 There is NO RISK

 

Click here to: "CONTACT US"

 

 

Outsourced Manufacturing:

Date:                   September-09

Industry:             Medical Device Mfg.

Company Type:   Start Up

Employees:          Between 50-100

Product:               Electro-Mechanical System (<6 Sub System Major Components)

 

Challenges:

- Current Facility to small to expand manufacturing for upcoming Product Launch

- Capital Funding limitations

- Company privately funded

- Equipment Constraints

- Insufficient Capacity

- Overhead expenses too high

- Supplier limitations for Scale Up of Mfg.

 

Considerations:

- Project Critical Path Lead Time

- Project Expenses

- Capital Expenses

- Resources

- Risk

 

Worked Performed /Accomplishments:

- Assembled Budget and obtained Approval

- Due Diligence performed on various Contract Manufacturers

- Quality Surveys created and obtained

- On-Site visits made to reassure capabilities of Contractors

- Quality and Mfg. Audits performed as needed

- Request for Quotes prepared and solicited

- Quotes obtained and Reviewed

- Contractor Selection Made

- Created Critical Contract Mfg. Agreements

- Duplicated Equipment, Fixtures and Work-cells as needed

- Transferred, setup, and Qualified all Assets

- Performed First Article Builds and Completed Inspection

- Performed additional Qualification Builds

- Adjusted Raw Component Inventory needs accordingly

 

Results:

- All Contractors approved for Mfg.

- Contract Agreements in Place

- Integrated Contractors into Supply Chain

- Gained sufficient increased capacity to meet demand forecast

- Kept Project Expenses within Budget

- Avoided $2M - $8M in Capital expenses (1-5 yrs) via Outsourcing

- Established Critical External Resources and Expertise

- Prevented any Back-order and Reduced Future Risks

- Established Target Opening Inventory

- Launched Product Using Contractors

- Scaled Volume as Needed

- Lowered Cost-of-Goods-Sold (COGS) by 20% for 1st year

 

Learnings and Post Project Review:

It is so crucially important to spend the time up front to perform the necessary Due Diligence for Contractor

selection. It is very tempting to select a contractor quickly and minimize the Due Diligence phase so that the

project will move faster, but be warned, it can easily come back to haunt you, just when your ready to scale

up your product line. How many have learned this hard lesson?

Those that have worked in the industry know exactly what I am referring to.

Backorder, lost sales, lost revenue, missed launch dates, sales that can not be made up for.

Closing Notation:

- Spend the time needed up front.

- Assure you thoroughly evaluate and Qualify your Contractor Supply Chain.

- Perform Contractor First Article Builds (start to finish).

- Use additional Contractor "Qualification" builds to complete Qualification.

- Work out your Contract Agreement early.

 

If you need assistance or consultation with any of the above activities, let us know.

We have been there before, many times.

We can help.

 

 Click here for more on:  OUTSOURCING

 Click here for more on:  SUPPLY CHAIN

 Click here for more on:  RESOURCES

Click here to:                    CONTACT US