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Quoting realistic process times and delivery dates.

Make sure that pricing is consistent from one quote to
the next

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Determine the timeframe that quotes will remain on the

table.

Related Standards have been reviewed and can be

met? Statutory - Rebgulatory - Quality - other
necessary and applicable standards?

Quoting

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Determine any ambiguous requirements, or

requirement implied but not stated and sign the
Customer Specification Review form.

Customer Requirements are understood and Can be

met for product acceptance, for delivery expections,
and for post-delivery expectations.

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Pull, print and read all applicable customer

specifications

Necessaey information is available: technical data,

specifications and standards, and drawings.

Failure to Check Visual Compliance Screening and

printing confirmation

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Poor external
communication,
Less effective
quoting process,
Overlooking a
customer
requirement

Medium

Medium

7/1/13

Sales Manager

Medium

Low

Medium

Low

Follow up RFQ customers with vendors

All salesmen must use price list that is on the sales
drive and maintained by management
Potential risk of inporting or exporting to companies or
parties on watch lists.

Methods of communication with the customer

are defined related to product information,
inquiries, feedback, concerns and complaints

Unclear or Ambiguous Requirements are resolved.

Review the Risk Register!

Not reviewing or discussing risk associated with the

part or processes
Copy and paste incorrect information

Review Customer requirements or ITP and note

Syteline. Ensure that internalk box is checked in notes
section.

Failure to utilize note section of Syteline for all to see

Reviewing all customer specifications and making

sure that it matches the equipment that was quoted.
2

Order Entry
Review all part numbers put in from engineering

Poor internal
communication,
Possible rework,
Customer claims

Sales department implemented the new customer spec

review form that has to be signed before processing the
purchase order/
Medium

Medium

7/1/13

Sales Manager All Salesmen will review the Bill of Material of every
assembly number put in from engineering.
Check Bill of Material and make sure it matches quote.

Unclear or Ambiguous Requirements are resolved.

Revalidate existing Quote.

Accepting quote prices after quote expiration date

Data entry error

Check order after completion for accuracy

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Contract Review
Participation of supplemental contract review if the
order or scope of the order changes.

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Salesperson for order should participate in the review.

Be fsamilsar with how to complete SCR form.

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Use supplemental contract review form.

Incomplete review of requirements

Not reviewing or discussing risk associated with the

part or processes involved.

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Missed
requirements,
Poor internal
communication,
Returned product,
Delivery Delay,
Reputation,
Failure to follow
company
procedures

Review the Risk Register. Change the form for Initial

review of order and the Supplemental Contract Review
for to add this responsibility for each review.
Medium

Medium

7/1/13

Sales Manager

Medium

Low

Medium

Low

Medium

Low

All orders will have a second review if the order gets

revised in any form

Manager or department representative at each meeting

Feasibility has been determined - capability,

equipment, floor space, adequate resources and
skilled personnel.

Documents should be filled out at the time of the

review.
Upper
Management

Lack of documented review for root cause and

corrective actions

Failure to identify and react to trends.

Customer Service, Perception
and Feedback
Customer perceives a lack of importance in meeting
their requirements

Lack of Customer
Confidence, Fewer
new Opportunities,
Company
Reputation

Corrective Action System in Place to Inform Upper

Management and determine Corrective action.
Medium

Medium

7/1/13
Salesperson interaction throughout the job, and
customer service afterwards
Call to see if customer is happy with their latest receipt
of product.

Negative perception and interaction with customers.

Multiple levels of review, approval and release

Releasing a drawing/specification with error(s)

Checklist of other associated areas of concern on EN

Failure to cover all associated documents and works

in process, when a revision is made.

Engineering

Failure to stay abreast of industry standards,

regulatory and statutory requirements and product
specifications.
Inconsistence from drawing to BOM

Ensure regularly scheduled customer feedback

meetings are held.

Manufacture to
incorrect revision.
In correction
revision sent to
supplier, incorrect
Bill of Materials

Ability to be alerted of changes to industry

standards/specifications
Medium

Medium

7/1/13

Director of
Engineering
Review Bill of Materials prior to release.
Perform departmental e-CAPA's to fix issues

Repeated like issues with drawings or specifications

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Follow up of Purchase Order

Select supplier with good quality and delivery

performance

Subcontracting for Outside processes

Utilize approved suppliers that have been ranked by

their ability to provide

Poor external
communication,
Delay or additional
expense in Material,
Late Delivery to
Customer
Inventory of rubber goods, due to poor quality and/or
late deliveries.
Selection of Supplier

Purchasing

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To be reviewed for completeness prior to issue

Failure to document all pertinent information needed

for the part, material purchase.

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High

Medium

7/1/13

Materials
Manager

Select suppliers who have stock or capacity and

working directily with the mills on supply forcasts

Medium

Low

Medium

Low

Added additional vendors, purchassed new multi-cavity

monds, having multiple molds and tooling at 2 or more
vendors for high usage/critical items

Availability of Raw materials or long lead times.

Failure to review and discuss risks associated with the
part or process.

Planning

Use of a Generic Router

Create an accurate plan for the router which relays each

step to the production floor.

Failure to include accurate and detailed information

Internal Communication - detailing what the customer

requirements are.

Inconsistence from drawing to ITP

Compare the ITP and Router prior to printing for job

packet

Production or Inspection Control Plan is incomplete.

Missing Hold Points and Witness points on router as
required per ITP

Inadequate
information relayed
to Production Floor,
Inspection,
Assembly or
Testing

Medium

Low

7/1/13

Materials
Manager

Add inspection points and hold points on router. Add

witness required on router

Failure to note inspection and sign-off for outsourced

operations

Place this requirement ( in process) inspection on the

router.

Inspections as required by process

Place inspection requirements on the router - receiving,

1st Article at each operation, in process, from
coating/testing, for labeling / serialization / stamping
and final, as applicable.
Perform visual inspection before signing

Condition of the container/packaging/stabilization

After visual inspection, if there is a discrepancy or

issue, notify QC and purchaser.

Visible damage
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Receiving

work with Engineering to create new part numbers to

meet current requirements

Correct quantity

Poor quality parts

end up in
warehouse

Medium

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Low

7/1/13

Materials
Manager

Compare PO to quantity received

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Materials
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Poor quality parts

end up in
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Check for completeness and certifications as required

All accompanying paperwork

Follow checklist & work instructions

Verifying all pertinent requirements

Follow sampling plan, unless customer requires greater

quantities sampled, or inconsistencies have been an
issue.

Failure to meet customer product requirements

Not following thru on witness or hold points

Not having Witness Reports in writing
Not writing NCR's as needed.
Damaged measuring instruments during checking
back in and they are piled up on the shelf.
9

Inspection

Missing Inspections reports from hold or witness

points on ITP with no explanation

Customer claims,
rework and scrap
parts, orders
delayed

Encourage the operators to be patient so proper handing

of the tool is maintained.
Medium

Don't leave the site until a copy is made available

Machinists are serializing parts and recording

dimensions.

API flange dimensions

Not reviewing previous findings

Pull history of NCR's on that product #

Periodic retraining, use of checklists, supply additional
resources

Verification of all paperwork for completeness

Lack of Control

QA/QC
Manager

Cross train Inspectors and certify as needed to perform

NDE and operate Roamer and CMM

Trained NDE or QC Inspector not available to

perform needed test or inspection on the Roamer or
CMM.

Lack of time frames for completion of entry,

processing, replies, and status reporting.

7/1/13

QC and Manufacturing purchase additional gages of the

popular sizes to be retained and checked out by QC

QC or Manufacturing gage is not readily available for

use

Poor external and internal communication

Medium

Delivery Delay,
Customer
dissatisfaction,
Fewer
Opportunities for
additional projects,
Loss of profit
ratio

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Measure progress by what your client and paying

customers care about rather than percentage complete
on a schedule or budget.

Set project goals and general time frames.

Check to confirm time frames are being met.

Medium

Low

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Not having anything in writing from customer

"saying it is ok"

Monitor and control change as it happens

Sending out MRB's with wrong info

Have regular meetings to communicate how things are

going on each project.

Not being familiar with the product

Medium

Medium

07/01/13

Sales Manager Training

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Project Management

Delivery Delay,
Customer
dissatisfaction,
Fewer
Opportunities for
additional projects,
Loss of profit
ratio
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Medium

Low

Medium

Low

Low

Low

No procedures or control method on what is required

on MRB's
Delays in material, manufacturing, testing, long lead
times and due date changes.

Monitor and control change as it happens

Unexpected delays or crisis that arise

Have regular meetings to communicate how things are

going on each project.

Not reviewing or discussing risk associated with the

part or processes

Communicate with customer both good and bad. Have

a plan of action when communicating the bad. If not,
ask for their assistance.

Issues during
Processing,
assembly/ testing /
coating /and
Galling, poor assembly, neglected proper inspection, painting . Company
painting and coating issues.
Liability Delayed
delivery
Failed NDE testing

Process one order at a time

Wrong parts/wrong quantity/parts left out

Follow instructions as laid out in tech manual or

assembly drawing
Report issues as soon as they are realized.
Secondary inspections

Fail to meet customer requirements

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Processing

Medium

Medium

7/1/13

Having Wrong Trace numbers documented

Manufacturing,
QA/QC,
Final Inspection
Check with Service and Sales to see if customer
mentioned returning an item.

Customer Returns with not RMA

Not enclosing all pertinent and required paperwork

Not meeting customer packaging requirements

Damaged Parts,
Rework, Scrap

Warehouse
Manager

Train in good packaging practices

Use good material handling practices, strong pallets
and clean protection.

Chance of handling or causing damage to product

Follow indoor spee restrictions.

12

Handling and Packaging

Medium
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Low

7/1/13

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Damaged Parts,
Rework, Scrap

Warehouse
Manager

Low

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Handling and Packaging

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Low

Block parts on pallet

Utilize sub-see pallets as required.

Bad/broken tooling/ programs/ set-up/measurement

Rework of parts
Scrapped Parts

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Manufacturing

Incorrect or poor place placement of labeling or

stamping of parts/product

Damage to
material / part
Additional
Material,
Rescheduling,
Rework, Scrap,
Returns from
customers,
Incomplete
documentation and
records

Spend time up front to set up properly, double check

for correct tooling, measure work as you go.

Call for first article

Medium

Low

Do not waste machine time on a bad part.

Medium

Medium

7/1/13

Manufacturing
Manager

Adequate job training on protecting the company and

customer property.

Not signing operations before moving to next step

Machines going down

Keep a "critical parts inventory" and complete PMCS

Talent

Multiple layers of talent/cross training

Take pride in your work, skills, and reputation amongst
peers.

Workmanship issues

Double check each item against the pick list

Not verifying right part number, right address, right

method of shipment
Not enclosing all paperwork

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Shipping

Invoiced not shipped

Sending to wrong
customer facility,
Longer staging wait
for instructions,
Customer claims,
Delay or penalty of
payment

:Low

Low

07/01/13

Warehouse
Manager

Teach to protect the company & customer property

Low

Low

Medium

Low

Chance of missing customer shipping requirements

Double check each item against the pick list

Pulling wrong parts

Good inventory practices

Parts in wrong locastion

Expired Stock
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Inventory

Personnel training on pulling inventory

Sending wrong
parts/quantities,
Low
Loss of stock, Loss
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Revenue

Medium

7/1/13

Warehouse
Manager

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7/1/13

Warehouse
Manager

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Incorrect labeling

Sending wrong
parts/quantities,
Loss of stock, Loss
Revenue
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Low

Low

Low

Low

Low

Low

Medium

Low

Spiders
Cycle counts are being verified by Warehouse Manager
and final verification by Materials Manager

Incorrect cycle count

INFRASTRUCTURE

Maintain effective maintenance program

Unexpected breakdown of manufacturing equipment

Good periodic maintenance service, and store data as

back up in an outside facility

Loss of machine programs

Utilize 2nd paint booth

Paint booth going down

Network going down
16
Air Compressor doing down

Have a copy of CNC programs stored locally

Disruption in
processing
Disruption in
business

Low

Low

7/1/13

Manufacturing
and
IT Manager Utilize back up air compressor
A Security officer in on the premises after business
work hours.

Security

Have back up equipment

Loss or Breakdown of business equipment (copiers,

copiers)

Store data as back up in a outside location.

Loss of data (server breakdown)

Generator - but limited performances

Lengthy power failure/ HVAC failure

Contingency Plans

Unforeseen Disruptions
Air Quality
17

WORK ENVIRONMENT

Work Space Organization

HUMAN RESOURCE

Damages to
property & products
Disruption in
business

Install Exhaust Fans, Change to a Synthetic Coolant

Low

Low

7/1/13

General
Manager

Implement 5S

Natural disasters

Disaster recovery Plan, Evacuation drills, Planning and

training of employees

Absenteeism

Cross training of employees

Inadequate Vacation/Sick time Planning

Cross training of employees

Lay Offs
Reduction of Force
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Disruption in
Low
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Low

7/1/13

General
Manager

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RISK REGISTER

Low

Low

7/1/13

General
Manager

Late delivery

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Low

Call- Inform Vendor - Then wait for corrected docs

Review delivery performance & notify

Total rejections
Shortages, Not
meeting customer
ship date

Medium

Medium

7/1/13

Materials and
QA/QC
Managers

Review total rejections & initiate corrective action

where required
Contact 2nd and 3rd suppliers to see if they have the
material needed on hand.

Main Supplier cannot or does not have the material

on hand as needed.
Failure to review Risk Register

Review the Risk Register

Incomplete
Wrong trace #'s provided

Trainning on how and importance of accuracy in

documenting the numbers

Inadequate certification documents for data packs

Call the Vendor when documents are first received, or

confirm exactly what is required for documentation
when placing the order.

delay in preparing required documents for customer

parts
DOCUMENTATION

Medium

Follow Purchase order to identify potential delay

Missing Certification

Material Returns

Low

Decreased Management of Employee Hours

Notice Given

SUPPLY CHAIN

Low
Random Drug Testing

Drug Use

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Disruption in
processing

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Retirement

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cross train in QA or bring in additional persons to train

Sending out MRB's with wrong info

Review, Review prior to sending

20
failure to print and review all required specifications

Assign responsibility

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Un-opened emails

EXTERNAL COMMUNICATION

21

Deviation Requests when docs are incorrect, missing

information, not filled out correctly, or sent to
customer incomplete
Missed calls or unreturned calls.

Assign Responsibility and Schedule

Un-opened emails

Schedule time for emails

Not sending information out to all concerned when

changes occur

CC to parties involved in the issue, or those that will be

involved in future processes.

Employee's taking short cuts

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Schedule time to review messages left on phones.

Utilize the Management of Change Form as required by

Q1.

INTERNAL COMMUNICATION

SAFETY

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Review before sending requests to customer

representative.

Not all managers are aware of what is going on to fix

an issue that affects their area also.

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Schedule time to review email.

Going to customers' information sites

22

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Injuries

Medium

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High

All Managers Attend training, Managers reminding employees

Medium

Medium