Supply Chain Liaison 5 Step 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 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
Identify
STEP 2
Document
STEP 3
Measure
STEP 4
Administer
STEP 5
Improve
 Step 1: Identify project team and project
liaison deliverables in assessing the supplier
in terms of their core competencies.
 Step 2: Document project team and project
liaison deliverables with the objective of
securing proper work instructions at the cell.
 Step 3: Measure project team and project
liaison deliverables in determining what
features are to be measure at what frequency.
 Step 4: Administer project team and project
liaison deliverables in correlating on
measurement accuracy between both parties.
 Step 5: Improve project team project liaison
deliverables toward continuous improvement.

6
Contents
 Overview
 Step 3: Measure
 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
Identify
STEP 2
Document
STEP 3
Measure
STEP 4
Administer
STEP 5
Improve

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•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
Identify
STEP 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
Identify
STEP 2
Document
STEP 3
Measure
STEP 4
Administer
STEP 5
Improve

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•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
Identify
STEP 2
Document
STEP 3
Measure
STEP 4
Administer
STEP 5
Improve

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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
Identify
STEP 2
Document
STEP 3
Measure
STEP 4
Administer
STEP 5
Improve

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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
Identify
STEP 2
Document
STEP 3
Measure
STEP 4
Administer
STEP 5
Improve

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Contents
 Overview
 Step 3: Measure
 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
Identify
STEP 2
Document
STEP 3
Measure
STEP 4
Administer
STEP 5
Improve

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•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
Identify
STEP 2
Document
STEP 3
Measure
STEP 4
Administer
STEP 5
Improve

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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
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STEP 2
Document
STEP 3
Measure
STEP 4
Administer
STEP 5
Improve

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•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
Identify
STEP 2
Document
STEP 3
Measure
STEP 4
Administer
STEP 5
Improve

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•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
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STEP 2
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STEP 3
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STEP 4
Administer
STEP 5
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•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
Identify
STEP 2
Document
STEP 3
Measure
STEP 4
Administer
STEP 5
Improve

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Contents
 Overview
 Step 3: Measure
 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
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STEP 2
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STEP 3
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STEP 4
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STEP 5
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•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
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STEP 2
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STEP 3
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STEP 4
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STEP 5
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•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
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STEP 2
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STEP 3
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STEP 4
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STEP 5
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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
Identify
STEP 2
Document
STEP 3
Measure
STEP 4
Administer
STEP 5
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•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
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STEP 2
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STEP 3
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•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
Identify
STEP 2
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STEP 3
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STEP 4
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STEP 5
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•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
Identify
STEP 2
Document
STEP 3
Measure
STEP 4
Administer
STEP 5
Improve

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Contents
 Overview
 Step 3: Measure
 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
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STEP 2
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STEP 3
Measure
STEP 4
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STEP 5
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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
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STEP 2
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STEP 3
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STEP 4
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STEP 5
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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
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STEP 2
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STEP 3
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STEP 4
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STEP 5
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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
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STEP 2
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STEP 3
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STEP 4
Administer
STEP 5
Improve

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Contents
 Overview
 Step 3: Measure
 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
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STEP 3
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STEP 4
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STEP 5
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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
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STEP 2
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STEP 3
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STEP 4
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STEP 5
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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
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STEP 2
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STEP 3
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STEP 4
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STEP 5
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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
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STEP 2
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STEP 3
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STEP 4
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STEP 5
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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
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STEP 2
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STEP 3
Measure
STEP 4
Administer
STEP 5
Improve

39
Contents
 Overview
 Step 3: Measure
 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
MEASURE
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/stephengoneil
Stephen O’Neil
P.O. Box 4753, Wilmington, NC 28406
Phone: 248-388-7071 • Email: stephen.g.oneil@gmail.com
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 background into a multi-faceted Supply Chain
Liaison role, as defined in detail with this 5 Step Plan. I look forward to sharing with you all that I’ve
gained in the way of experience, (certainly in part with lessons learned), but also with the excitement in
sharing the journey!
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.

Supply Chain Liaison 5 Step Management Program

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