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RISK REGISTER

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Pull, print and read all applicable customer
Necessaey information is available: technical data,
specifications
specifications and standards, and drawings.
Determine any ambiguous requirements, or
Customer Requirements are understood and Can be requirement implied but not stated and sign the
met for product acceptance, for delivery expections, Customer Specification Review form.
and for post-delivery expectations.

Determine the timeframe that quotes will remain on the

Related Standards have been reviewed and can be
table.
met? Statutory - Rebgulatory - Quality - other
necessary and applicable standards?

Poor external
Failure to Check Visual Compliance Screening and communication,
printing confirmation Less effective
1 Quoting quoting process, Medium Medium 7/1/13 Sales Manager Medium Low
Quoting realistic process times and delivery dates. Overlooking a Follow up RFQ customers with vendors
customer
requirement All salesmen must use price list that is on the sales
Make sure that pricing is consistent from one quote to
drive and maintained by management
the next

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

Failure to utilize note section of Syteline for all to see Syteline. Ensure that internalk box is checked in notes
section.

Sales department implemented the new customer spec

Reviewing all customer specifications and making review form that has to be signed before processing the
sure that it matches the equipment that was quoted. purchase order/
Poor internal
communication,
2 Order Entry Medium Medium 7/1/13 Sales Manager All Salesmen will review the Bill of Material of every Medium Low
Possible rework,
Review all part numbers put in from engineering Customer claims 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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RISK REGISTER

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Use supplemental contract review form.
Incomplete review of requirements

Salesperson for order should participate in the review.

Be fsamilsar with how to complete SCR form.
Salespersons lack of participation

Missed
requirements, Review the Risk Register. Change the form for Initial
Not reviewing or discussing risk associated with the Poor internal review of order and the Supplemental Contract Review
part or processes involved. communication, for to add this responsibility for each review.
Returned product,
3 Contract Review Medium Medium 7/1/13 Sales Manager Medium Low
Delivery Delay,
Reputation, All orders will have a second review if the order gets
Participation of supplemental contract review if the Failure to follow revised in any form
order or scope of the order changes. company
procedures
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.

Lack of documented review for root cause and Upper Ensure regularly scheduled customer feedback
corrective actions Management meetings are held.

Corrective Action System in Place to Inform Upper

Lack of Customer Management and determine Corrective action.
Failure to identify and react to trends.
Confidence, Fewer
Customer Service, Perception
new Opportunities, Medium Medium 7/1/13 Medium Low
and Feedback
Company Salesperson interaction throughout the job, and
Customer perceives a lack of importance in meeting Reputation customer service afterwards
their requirements

Call to see if customer is happy with their latest receipt

Negative perception and interaction with customers. of product.
4
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.

Ability to be alerted of changes to industry

Failure to stay abreast of industry standards, Manufacture to standards/specifications
regulatory and statutory requirements and product incorrect revision.
specifications. In correction Director of
5 Engineering Medium Medium 7/1/13 Medium Low
revision sent to Engineering
supplier, incorrect Review Bill of Materials prior to release.
Inconsistence from drawing to BOM Bill of Materials

Perform departmental e-CAPA's to fix issues

Repeated like issues with drawings or specifications

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To be reviewed for completeness prior to issue
Failure to document all pertinent information needed
for the part, material purchase.

Select supplier with good quality and delivery

Follow up of Purchase Order performance

Utilize approved suppliers that have been ranked by

Subcontracting for Outside processes their ability to provide
Poor external
Selection of Supplier communication,
Select suppliers who have stock or capacity and
Delay or additional Materials
6 Purchasing High Medium 7/1/13 working directily with the mills on supply forcasts Medium Low
expense in Material, Manager
Late Delivery to Added additional vendors, purchassed new multi-cavity
Inventory of rubber goods, due to poor quality and/or Customer monds, having multiple molds and tooling at 2 or more
late deliveries. 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.

Create an accurate plan for the router which relays each

Use of a Generic Router step to the production floor.

Internal Communication - detailing what the customer

Failure to include accurate and detailed information requirements are.

Compare the ITP and Router prior to printing for job

Inconsistence from drawing to ITP packet
Inadequate
information relayed work with Engineering to create new part numbers to
Production or Inspection Control Plan is incomplete. to Production Floor, Materials meet current requirements
7 Planning Medium Low 7/1/13 Medium Low
Inspection, Manager
Assembly or Add inspection points and hold points on router. Add
Missing Hold Points and Witness points on router as
Testing witness required on router
required per ITP

Failure to note inspection and sign-off for outsourced Place this requirement ( in process) inspection on the
router.
operations

Place inspection requirements on the router - receiving,

1st Article at each operation, in process, from
Inspections as required by process 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

Visible damage issue, notify QC and purchaser.

Poor quality parts Compare PO to quantity received

Materials
8 Receiving Correct quantity end up in Medium Low 7/1/13
Manager
warehouse

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8 Receiving end up in Medium Low 7/1/13

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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
Failure to meet customer product requirements
issue.

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 Encourage the operators to be patient so proper handing
of the tool is maintained.
back in and they are piled up on the shelf. Customer claims,
rework and scrap QA/QC
9 Inspection Medium Medium 7/1/13 Don't leave the site until a copy is made available Medium Low
Missing Inspections reports from hold or witness parts, orders Manager
points on ITP with no explanation delayed

QC and Manufacturing purchase additional gages of

QC or Manufacturing gage is not readily available for the popular sizes to be retained and checked out by QC
use

Trained NDE or QC Inspector not available to Cross train Inspectors and certify as needed to perform
perform needed test or inspection on the Roamer or NDE and operate Roamer and CMM
CMM.
Machinists are serializing parts and recording
API flange dimensions dimensions.

Not reviewing previous findings

Pull history of NCR's on that product #

Periodic retraining, use of checklists, supply additional

Verification of all paperwork for completeness
resources

Delivery Delay,
Customer Measure progress by what your client and paying
Poor external and internal communication
dissatisfaction, customers care about rather than percentage complete
Fewer on a schedule or budget.
Opportunities for
Lack of time frames for completion of entry,
additional projects, Set project goals and general time frames.
processing, replies, and status reporting.
Loss of profit
ratio
Lack of Control Check to confirm time frames are being met.

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Delivery Delay,
Customer RISK REGISTER
dissatisfaction,
Fewer
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Not having anything in writing from customer
Monitor and control change as it happens
"saying it is ok"
Have regular meetings to communicate how things are
Sending out MRB's with wrong info
going on each project.

10 Project Management Not being familiar with the product Medium Medium 07/01/13 Sales Manager Training Medium Low
No procedures or control method on what is required
on MRB's

Delays in material, manufacturing, testing, long lead

Monitor and control change as it happens
times and due date changes.

Have regular meetings to communicate how things are

Unexpected delays or crisis that arise
going on each project.

Communicate with customer both good and bad. Have

Not reviewing or discussing risk associated with the
a plan of action when communicating the bad. If not,
part or processes
ask for their assistance.

Issues during Process one order at a time

Wrong parts/wrong quantity/parts left out Processing,
assembly/ testing /
coating /and Follow instructions as laid out in tech manual or
Galling, poor assembly, neglected proper inspection, painting .
painting and coating issues. assembly drawing
Company Liability
Delayed delivery
Report issues as soon as they are realized.
Failed NDE testing

Secondary inspections
Fail to meet customer requirements
Manufacturing,
11 Processing Medium Medium 7/1/13 Medium Low
QA/QC, Final Inspection
Having Wrong Trace numbers documented

Check with Service and Sales to see if customer

Customer Returns with not RMA mentioned returning an item.

Not enclosing all pertinent and required paperwork

Damaged Parts, Warehouse Train in good packaging practices

Not meeting customer packaging requirements Rework, Scrap Manager

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 Low 7/1/13 Low Low

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Damaged Parts, Warehouse

Rework, Scrap Manager
RISK REGISTER

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12 Handling and Packaging Medium Low 7/1/13 Low Low
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Block parts on pallet

Utilize sub-see pallets as required.

Damage to Spend time up front to set up properly, double check

Bad/broken tooling/ programs/ set-up/measurement material / part for correct tooling, measure work as you go.
Additional
Material,
Rework of parts Rescheduling,
Rework, Scrap, Call for first article Medium Low
Returns from
Scrapped Parts customers,
Incomplete Do not waste machine time on a bad part.
documentation and
records Adequate job training on protecting the company and
Incorrect or poor place placement of labeling or
customer property.
stamping of parts/product Manufacturing
13 Manufacturing Medium Medium 7/1/13
Manager
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
Workmanship issues peers.

Not verifying right part number, right address, right Double check each item against the pick list
method of shipment

Not enclosing all paperwork Sending to wrong

customer facility,
Longer staging wait Teach to protect the company & customer property
Invoiced not shipped Warehouse
14 Shipping for instructions, :Low Low 07/01/13 Low Low
Manager
Customer claims,
Delay or penalty of
payment

Chance of missing customer shipping requirements

Double check each item against the pick list

Pulling wrong parts

Good inventory practices

Parts in wrong locastion

Personnel training on pulling inventory

Expired Stock Sending wrong
parts/quantities, Warehouse
15 Inventory Low Medium 7/1/13 Medium Low
Loss of stock, Loss Manager
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15 Inventory Low Medium 7/1/13 Medium Low
Loss of stock, Loss Manager Exterminate on seasonal insects and spiders
Incorrect labeling Revenue

Spiders

Cycle counts are being verified by Warehouse Manager

Incorrect cycle count and final verification by Materials Manager

INFRASTRUCTURE Maintain effective maintenance program

Unexpected breakdown of manufacturing equipment

Good periodic maintenance service, and store data as

Loss of machine programs back up in an outside facility

Utilize 2nd paint booth

Paint booth going down

Have a copy of CNC programs stored locally

Network going down Disruption in
Manufacturing
processing
16 Low Low 7/1/13 and Low Low
Disruption in
IT Manager Utilize back up air compressor
Air Compressor doing down business

A Security officer in on the premises after business

Security work hours.

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

Install Exhaust Fans, Change to a Synthetic Coolant

Air Quality Damages to
property & products General
17 WORK ENVIRONMENT Low Low 7/1/13 Implement 5S Low Low
Disruption in Manager
Work Space Organization
business

Disaster recovery Plan, Evacuation drills, Planning and

Natural disasters training of employees
HUMAN RESOURCE Cross training of employees
Absenteeism

Inadequate Vacation/Sick time Planning Cross training of employees

Lay Offs
Reduction of Force
Disruption in General
18 Low Low 7/1/13 Low Low
processing Manager
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HUMAN RESOURCE

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Disruption in General
18 Low Low 7/1/13 Low Low
Retirement processing Manager

Random Drug Testing

Drug Use

Decreased Management of Employee Hours

Notice Given

Late delivery
Follow Purchase order to identify potential delay

Missing Certification
Call- Inform Vendor - Then wait for corrected docs
Review delivery performance & notify
Total rejections
Shortages, Not Materials and
19 SUPPLY CHAIN meeting customer Medium Medium 7/1/13 QA/QC Medium Low
Material Returns Review total rejections & initiate corrective action
ship date Managers
where required

Main Supplier cannot or does not have the material Contact 2nd and 3rd suppliers to see if they have the
on hand as needed. material needed on hand.

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

Call the Vendor when documents are first received, or

Inadequate certification documents for data packs confirm exactly what is required for documentation
when placing the order.

delay in preparing required documents for customer

parts cross train in QA or bring in additional persons to train

DOCUMENTATION Sending out MRB's with wrong info

20 Review, Review prior to sending

failure to print and review all required specifications

Assign responsibility

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Un-opened emails
Schedule time to review email.

Deviation Requests when docs are incorrect, missing

EXTERNAL COMMUNICATION information, not filled out correctly, or sent to
customer incomplete Review before sending requests to customer
representative.
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Missed calls or unreturned calls.
Schedule time to review messages left on phones.

Going to customers' information sites

Assign Responsibility and Schedule

Un-opened emails Schedule time for emails

Not sending information out to all concerned when CC to parties involved in the issue, or those that will be
changes occur involved in future processes.

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

an issue that affects their area also. Utilize the Management of Change Form as required by
Q1.
22 INTERNAL COMMUNICATION

23 SAFETY Employee's taking short cuts Injuries Medium High All Managers Attend training, Managers reminding employees Medium Medium

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 RISK
FREQUE RISK
NCY LEVEL

16 &
ABOVE V.HIGH
11-15 HIGH
6-10 MEDIUM
5 OR
LESS LOW