Supply Chain Liaison Management Program

Supply Chain Program Management

& Process Controls

This presentation will explore the role of Supply Chain Liaison in order to facilitate the qualifying of a Supplier of

manufactured goods. Traditionally, the Customer, or provider of devices to the marketplace, have directly dealt

with the Supplier through the in-house Purchasing group; with less than adequate support in fulfilling the orders

on-time with quality initiatives met. This is due in large part to in-house responsibilities taking precedence with

the Manufacturing & Quality Engineers. The Supply Chain Liaison will work in this role while bridging the gap

between the Supplier & Customer in meeting the product launch requirements, followed by sustaining cost saving

initiatives that follow thereafter.

2

Contents

Overview 3

Step 1: Identify 6

Step 2: Document 13

Step 3: Measure 20

Step 4: Administer 28

Step 5: Improve 33

Summary 40

3

Contents

Overview

Step 1: Identify

Step 2: Document

Step 3: Measure

Step 4: Administer

Step 5: Improve

Summary

4

In tracking with the five steps toward establishing the integrity of the manufacturing process, we’ll

examine the team contributions based on:

Project Team Deliverables to include the collaborative effort of the Liaison & Customer in

identifying & ultimately qualifying the Supplier

Project Liaison Deliverables based on the above inputs

This document defines and explains the 5-step process to Supply Chain Management and establishing process controls

Supply Chain Management & Process Controls – Overview

5

The diagram below lays out the 5 step approach to our supply chain management and process control framework

5-Step Approach

TextSTEP 1

IdentifySTEP 2

Document

STEP 3

Measure

STEP 4

Administer

STEP 5

Improve

Step 1: Identify project team and project

liaison deliverables

Step 2: Document project team and project


Step 3: Measure project team and project


Step 4: Administer project team and project


Step 5: Improve project team project liaison

deliverables

6

Contents

Overview

Step 1: Identify

Step 2: Document

Step 3: Measure

Step 4: Administer

Step 5: Improve

Summary

7

Step 1: Identify Project Team Deliverables

Project Team Decision (1 of 4)

PROJECT TEAM DECISION

•Determine supplier, based on primary & secondary processes

1. How vertically integrated are they?

a.In other words, are they equipped to capture all of the processes required to produce your

product internally?

2. If not, what processes would have to be outsourced?

a.This is important as the likelihood of controlling lead times is diminished with outsourcing

on the part of your supplier.

b.This determination also will contribute significantly toward the line item costs and should be

vetted out before the actual quote requests are issued.

TextSTEP 1

IdentifySTEP 2

Document

STEP 3

Measure

STEP 4

Administer

STEP 5

Improve

8




•Identify applicable core competencies exist

1. Is there a strategic fit for this supplier with respect to the product to be manufactured in question?

a.Ensure that the Supplier is an “Expert” in the processing of parts similar to your product targeted for outsourcing

2. What is their track record in the industry as it pertains to similar product produced for other OEM’s?

a.Research in determining not only whether or not the capability is there, but to what level of success.

3. Finally, if not already an established supplier with your company, how much opportunity is there elsewhere in your portfolio?

a.When assessing the value a new supplier would bring to your new product, be certain that there’s an opportunity to help consolidate your supplier list in allowing for the occasion to bring them in on other legacy product.

TextSTEP 1

IdentifySTEP 2

Document

STEP 3

Measure

STEP 4

Administer

STEP 5

Improve

9




•Confirm project team resources are available

1.On the part of the Supplier there should be Manufacturing, Procurement, and

Quality represented.

a.Ensure that the identified resources also have the sufficient % of their time

appropriately allocated to the new product line.

2.On the Customer front, as typical with most OEM new project teams, there

should be Manufacturing, Quality, Procurement, Regulatory, and Marketing.

a.Must also ensure that the individuals have the appropriate % of their day

dedicated to the activities surrounding this new product line.

3.Meet with Supplier management to confirm team buy-in & resource allocation

TextSTEP 1

IdentifySTEP 2

Document

STEP 3

Measure

STEP 4

Administer

STEP 5

Improve

10




•Ensure the ability of the supplier in having met Quality CFR Title 21, Part 820

requirements

1. Design Control phase gates are honored as per the above Section 820.30 that

speaks to the FDA’s Subpart on Quality System Regulation

a.In this collaborative effort on the part of the Customer & Supplier, ensure that all phase

gates allow for design for manufacturing & allow for inputs on the part of the Supplier.

b.As per the required documentation, evidence on the part of the Supplier will be provided to

ensure the translation of the design to manufacture is consistently held leading up to and

including the eventual production lots.

TextSTEP 1

IdentifySTEP 2

Document

STEP 3

Measure

STEP 4

Administer

STEP 5

Improve

11

Step 1: Identify Project Liaison Deliverables

Project Liaison Deliverables (1 of 2)

PROJECT LIAISON DELIVERABLE

•Perform on-site analysis of supplier quality management system

1. In tandem with the Customer’s own quality representative, assess the quality

system.

2. In addition, along with Manufacturing Engineer representative on behalf of the

Customer, assess the manufacturing equipment responsible for the product.

3. Finally, complete the appropriate checklists & assessment forms in determining the

eligibility and certification on the part of the supplier.

TextSTEP 1

IdentifySTEP 2

Document

STEP 3

Measure

STEP 4

Administer

STEP 5

Improve

12

Step 1: Identify Project Liaison Deliverables



•Establish Project Charter to ensure buy-in from both the supplier & the

customer team members

1. As the primary with respect to authoring the Charter, document the project with

respect to the project objectives, timeline, and deliverables in scoping the work.

2. Engage both teams to establish the buy-in necessary in relaying the message of

the charter.

3. Assign roles & responsibilities moving forward in meeting the project initiatives and

kick-off the project deliverables while signing off on the charter documentation.

TextSTEP 1

IdentifySTEP 2

Document

STEP 3

Measure

STEP 4

Administer

STEP 5

Improve

13

Contents

Overview

Step 1: Identify

Step 2: Document

Step 3: Measure

Step 4: Administer

Step 5: Improve

Summary

14

Step 2: Document Project Team Deliverables



•Introduce the equipment to be utilized for all processes required

1. Computer Numerical Controlled, (CNC), equipment identified for all processes

related to the manufacture of targeted product.

2. All CNC software to be verified as part of the equipment identified above.

3. All Fixtures & Gages already in place that speak to the manufacture of the product

in question.

4. Coordinate Measuring Machines, or CMM equipment identified as part of the

inspection process for targeted manufactured product.

TextSTEP 1

IdentifySTEP 2

Document

STEP 3

Measure

STEP 4

Administer

STEP 5

Improve

15




•Develop Action Plan from which new process specific parameters will be

driven, (Master Validation Plan)

1. Master Validation Plan, (MVP), will identify the necessary protocols for all

equipment and processes as required.

2. May include, (if not already performed), Installation Qualification Protocols for any

automated equipment.

3. Any Process Operational Qualifications related to equipment connected to the

processes required for manufacture.

4. All Process Performance Qualifications related to equipment also tied to the

processes defined for manufacture of product.

TextSTEP 1

IdentifySTEP 2

Document

STEP 3

Measure

STEP 4

Administer

STEP 5

Improve

16

Step 2: Document Project Liaison Deliverables



•Perform on-site analysis at the source of supplier processes and equipment

1. Assess the equipment to be validated in a production environment with obviously no exposure to the specifics of the parts being produced.

2. Verify that the previously identified SOP’s & WI’s are present and accounted for at the machining cell.

3. Visually account for the appropriate line clearances in both the set-up as well as the closing out of an operation.

4. Determine that all training and maintenance manuals & logs are present and accounted for at the equipment cell.

5. Visit the Quality inspection cell for Final and In-Process inspection in reviewing the applicable gages & inspection logs consistent with your product requirements.

TextSTEP 1

IdentifySTEP 2

Document

STEP 3

Measure

STEP 4

Administer

STEP 5

Improve

17




•Draft Process Operational Protocols, POQ’s, in defining existing supplier process documentation & equipment

1. Intent here is to capture the necessary outputs in determining that the equipment will produce acceptable results in a production setting.

a.This would include outputs based on anticipated operating conditions to include upper/lower worst case conditions

b.Once proved successful, will demonstrate that the system through all operating ranges allows for the desired requirements as outlined in the Master Validation Protocol.

c.Will include all identified documentation that address the set-up, in-process inspection, and handling of line clearance at the machine cell.

2. Route the completed protocols for approval on the part of both the Customer and the Supplier.

TextSTEP 1

IdentifySTEP 2

Document

STEP 3

Measure

STEP 4

Administer

STEP 5

Improve

18




•Execute on all POQ’s & capture data

1. Once protocol has been approved, execute as per the protocol equipment

repeatability and record.

a.CNC Machine Axis Repeatability

b.Spindle Speed, or RPM’s as gaged at both the maximum and low extremes as well as the

mean rate.

c.Spindle Run out at taper falls within previously determined range.

d.Contour or profile of a surface is falling within an acceptable range.

e.CNC Software controls are verified by bringing about the necessary alarms in determining

over travel and improper coding in the programs.

f.Examine the designated product features as to the statistical variation when equipment is

running at the extreme & mean rates of speed.

TextSTEP 1

IdentifySTEP 2

Document

STEP 3

Measure

STEP 4

Administer

STEP 5

Improve

19




•Route all POQ’s for approval

1. Route the completed reports for approval on the part of both the Customer and the

Supplier.

a.Include all data record tables as addendums with report.

2. Capture final electronically signed off documentation and place card this material

within the Master Validation Plan for safekeeping.

TextSTEP 1

IdentifySTEP 2

Document

STEP 3

Measure

STEP 4

Administer

STEP 5

Improve

20

Contents

Overview

Step 1: Identify

Step 2: Document

Step 3: Measure

Step 4: Administer

Step 5: Improve

Summary

21

Step 3: Measure Project Team Deliverables



•Ascertain the applicable processes parameters from which to take measurements

1. Make note of dimensional characteristics deemed critical for design integrity.

2. Prioritize those measureable features that present challenges to the process.

3. Assess the minimal metal removal processes for their impact on the variability of the manufactured component, i.e., polishing, blasting, anodizing, etc.

4. Additionally, consider challenges to certain features where there’s ability to negotiate from a design perspective, if challenges in maintaining manufacturability are deemed likely.

TextSTEP 1

IdentifySTEP 2

Document

STEP 3

Measure

STEP 4

Administer

STEP 5

Improve

22




•Determine sample size & statistical reliability

1. With a minimum sample size of 30 pieces to be considered, based on the Central

Limit Theorem where a distribution stabilizes after approximately 30 pieces,

determine your desired minimum target requirement, or Cpk of perhaps 1.33, with

probability of less than 1 piece per million non-conforming.

2. To demonstrate repeatability across lots, two additional lots of 30 are required.

3. Based on a percentile, agree upon a Reliability & Confidence level percentage for

statistical reliability.

4. Based on these figures, determine the actual number of pieces to be run from the

calculation, where c = Confidence level, and q = Reliability, and n = Sample Size

TextSTEP 1

IdentifySTEP 2

Document

STEP 3

Measure

STEP 4

Administer

STEP 5

Improve

23




•Develop the quality inspection methods to be included in the process parameters qualification

1. Now that the process features & controls to be measured have been defined, for each, determine the method of inspection, i.e.,

2. Determine which are Variable, discreet measurement or Attribute, as in Pass/Fail

a.Calipers?

b.Micrometers?

c.Overlays? (Attribute only)

d.CMM?

e.Thread/Ring/Pin, or Custom Gages

3. If Custom gages are required, cut down lead time with non-production material specifications if long lead times in Gage manufacturing is an issue.

TextSTEP 1

IdentifySTEP 2

Document

STEP 3

Measure

STEP 4

Administer

STEP 5

Improve

24

Step 3: Measure Project Liaison Deliverables



•Draft Process Performance Protocols, PPQ’s, in determining supplier

capability

1. Intent here is to capture the necessary outputs in determining that the process

critical features will produce acceptable results in a production setting.

a.This would include the aforementioned 3 production setting piece runs, while centering the

process and performing a 6 sigma assessment on the results.

b.Once proved successful, will demonstrate the statistical evidence that will allow for the

desired requirements as outlined in the Master Validation Protocol.

2. Route the completed protocols for approval on the part of both the Customer and

the Supplier.

TextSTEP 1

IdentifySTEP 2

Document

STEP 3

Measure

STEP 4

Administer

STEP 5

Improve

25




•Execute on all PPQ’s & capture data

1. Once protocol has been approved, execute as per the protocol and record.

a.Will include all captured variable features in a spreadsheet addendum to provide statistical

evidence of a process in control.

b.Provide 6 Sigma graphs to illustrate the findings of the data captured in the spreadsheet

addendum.

2. Record any deviations or Non-Conformances that may have occurred during the

validation runs for review.

a.If deemed acceptable, the non-conforming features to the protocol may be flagged for a

higher level of inspection later, whereby allowing for all other process variables and

therefore the validation, to move forward.

TextSTEP 1

IdentifySTEP 2

Document

STEP 3

Measure

STEP 4

Administer

STEP 5

Improve

26




•Capture costs associated with processes in establishing baseline for ROI

1. With the help of an inspection plan based on the process validation, determine

costs to manufacture and inspect, based on the pre-determined optimum lot size.

2. Assess material costs associated with each component

3. Calculate labor as part of the exercise and an overhead rate for in process

inspection & auditing.

4. Finally, if assembly costs are to be included, roll all components into inventory and

assess the cost of assembly work on it’s own merit.

TextSTEP 1

IdentifySTEP 2

Document

STEP 3

Measure

STEP 4

Administer

STEP 5

Improve

27




•Route all PPQ’s for approval

1. Route the completed reports for approval on the part of both the Customer and the

Supplier.

a.Include all data record tables as addendums with report.

2. Capture final electronically signed off documentation and place card this material

within the Master Validation Plan for safekeeping.

TextSTEP 1

IdentifySTEP 2

Document

STEP 3

Measure

STEP 4

Administer

STEP 5

Improve

28

Contents

Overview

Step 1: Identify

Step 2: Document

Step 3: Measure

Step 4: Administer

Step 5: Improve

Summary

29

Step 4: Administer Project Team Deliverables



•Correlate inspection measurements between the Supplier & Customer Teams

1. With the Quality representatives on both sides at a minimum, perform a gage R&R

with pieces already ran during the PPQ in order to establish accuracy between

measuring systems on both sides.

2. Collaborate on a draft of the Gage R&R protocol for approval.

3. Once approved, initiate the inspection activities on the part of the Customer,

followed by the Supplier, and return to the Liaison for an overall committee review.

TextSTEP 1

IdentifySTEP 2

Document

STEP 3

Measure

STEP 4

Administer

STEP 5

Improve

30

Step 4: Administer Project Team Deliverables



•Determine the new frequency of measurement & confirm methods of

inspection

1. Based on the results of the PPQ’s, determine which features should be measured

with an increased sampling rate.

2. Once the inspection plan is complete in addressing the rate of inspection, begin

draft of a Control Plan.

3. Finalize the methods of inspection for sake of the Control Plan and compile the

required quality inspection records for capturing the data.

4. Provide all documentation to both teams in addressing both in-process and final

inspection quality departments.

TextSTEP 1

IdentifySTEP 2

Document

STEP 3

Measure

STEP 4

Administer

STEP 5

Improve

31

Step 4: Administer Project Liaison Deliverables



•Route MVP Report in qualifying supplier

1. At this point, once all documentation has been rolled in to the MVP by the Liaison,

he or she must then meet with both the Supplier & Customer teams in

communicating the results.

2. Review overall performance and approve the MVP for sake of compiling the results

into the subsequent Master Validation Report, (MVR), for approval.

3. In approving the report, committee featuring both teams then agree to initiate the

defining of the process improvement activities in the interest of process sustaining

efforts.

TextSTEP 1

IdentifySTEP 2

Document

STEP 3

Measure

STEP 4

Administer

STEP 5

Improve

32

Step 4: Administer Project Liaison Deliverables



•Capture inspection cost savings and adjust baseline for ROI

1. Adjust for reduced incoming inspection on the part of the Customer’s final

inspection team, based on the results of the Gage R&R & Process Validation

results.

2. Refresh the numbers from the prior exercise in establishing baseline costs

associated with the overall manufacturing process.

3. Calculate new ROI based on these results in leading to the final step in working

further to streamline our operating costs.

TextSTEP 1

IdentifySTEP 2

Document

STEP 3

Measure

STEP 4

Administer

STEP 5

Improve

33

Contents

Overview

Step 1: Identify

Step 2: Document

Step 3: Measure

Step 4: Administer

Step 5: Improve

Summary

34

Step 5: Improve Project Team Deliverables



•Determine scope & resources for future state of process

1. Often with less representation, two teams, once again representing the Supplier &

Customer sites, are to be formed for sustaining activities moving forward.

2. Representatives from both teams meet with Customer Executive Management in

determining the scope of the project agenda.

TextSTEP 1

IdentifySTEP 2

Document

STEP 3

Measure

STEP 4

Administer

STEP 5

Improve

35

Step 5: Improve Project Team Deliverables



•Plan follow-up strategic planning sessions for continued sustaining activities

1. From there, draft a charter and schedule for the two teams to meet in addressing

the previously agreed to agenda items for continuous improvement.

2. Route the Project Charter for approval and initiate activities with a joint meeting

between the two project teams to kick off the effort.

TextSTEP 1

IdentifySTEP 2

Document

STEP 3

Measure

STEP 4

Administer

STEP 5

Improve

36

Step 5: Improve Project Liaison Deliverables


PROJECT LIAISON DELIVERABLES

•Establish Floor feedback in providing support to sustaining teams

1. The best source for sustaining efforts is at the operator level. Ensure that the

information and interviews are taking place in describing the nuances behind the

operation for increased visibility of the process.

2. Examples include the cost savings realized on the operating floor by way of

enhanced technology and/or time saving innovations provided by way of operator

feedback.

3. Establish the data stream from which the statistical process controls are captured

in the interest of process improvements moving forward.

TextSTEP 1

IdentifySTEP 2

Document

STEP 3

Measure

STEP 4

Administer

STEP 5

Improve

37




•Draft & approve a Dock to Stock or Inspection instruction for incoming inspection

1. With enough statistical data and inspection reports to support it, a Dock to Stock plan in all but eliminating incoming inspection should be initiated.

2. Draft of protocol would include a provision for audited inspection on a random basis, but the objective would be leverage a robust validated process to include the extensive cost savings that would result from this.

3. Route protocol for subsequent approval and implementation within the organization.

4. Revisit the baseline costs associated with the manufacturing process to realize the reduction in operating costs toward the product ROI.

TextSTEP 1

IdentifySTEP 2

Document

STEP 3

Measure

STEP 4

Administer

STEP 5

Improve

38




•Establish Kanban system of supplier managed inventory

1. Once having implemented the cost saving initiatives provided by reduced inspection and sustaining activities in manufacturing, consideration must be given to supplier managed inventory.

2. By now the trust has risen to include correlation on the inspection front, and process costs can be further reduced with controlled inventory.

3. Once inventory loads can be estimated with the proper level of confidence, further cost savings are realized with the just in time delivery of product to the customer for the build out of sets.

4. Over time, with enough trending data on the demand for product, these costs will again transfer to the bottom line for enhanced cost savings.

TextSTEP 1

IdentifySTEP 2

Document

STEP 3

Measure

STEP 4

Administer

STEP 5

Improve

39

Contents

Overview

Step 1: Identify

Step 2: Document

Step 3: Measure

Step 4: Administer

Step 5: Improve

Summary

40

The Supply Chain Liaison will continue to manage the sustaining effort

Summary

With the Supply Chain Liaison leading the effort, we will continue to decrease costs with an

emphasis on process improvements in coordinating the effort with the Customer Executive Team.

time

ME

AS

UR

E

Continuous

Improvement

Breakthrough!

STEP 1

Identify STEP 2

Document

STEP 3

Measure

STEP 4

Administer

STEP 5

Improve

41

About the Author, Stephen O’Neil

You can connect with Stephen O’Neil on LinkedIn here: https://www.linkedin.com/in/steveoneil.

Stephen O’Neil

P.O. Box 4753, Wilmington, NC 28406

Phone: 248-388-7071 • Email: [email protected]

Over the course of my career I've had the pleasure to have worked in several capacities. All of which

has led me to the point where I see myself blending that combined experience into a multi-faceted

position. I look forward to my next opportunity as one that would allow me to leverage these specific

roles.

1. As an entrepreneur in my business partnership, I was able to help build on a business plan in

presenting engineering solutions that would include scanning & database documentation along

with design engineering contract placement. This included marketing two facilities out of both

the UK & US while traversing these diverse markets in growing the business.

2. In the role of a contract manufacturer representative, as both a Project Engineer in developing

prototype manufacturing cells, and as Project Manager representing our customer’s needs;

delivered on new product based on the orthopedic customer’s design intent.

3. And finally, over the past several years in representing MIS Spine new project teams in the role of

a Manufacturing Engineer, led the manufacturing effort to bring about product launches, through

both internal & external supply chain resources, in expediting new product to market in support of

the Thoracic Lumbar, Anterior Cervical, and Posterior Lumbar regions.

https://www.linkedin.com/in/steveoneil

mailto:[email protected]

Engineering

Supply Chain Liaison Management Program