Interested Party Int / Ext

Attorney Internal
Certification Body External
CPA Internal
Direct Customer External
Employee / Staff Internal
Investors Internal
Labor Union Representatives External
Local Community External
Parent Company Internal
Product End User External
Public External
Regulatory Bodies External
Staffing Agencies External
Supplier External
Top Management Internal
 COTO Log: Interested Parties List Rev. 0
Reason for Inclusion
Provides legal services
Audit for ISO 9001 compliance, issue certifications
Provides accounting services and annual financial reviews
Purchase our products and services
Directly responsible for manufacture of products, delivery of service
Concerned with financial health of the company
Interfaces with management and labor union
Impacted by our activities in the region
Concerned with financial health of the company
End user of our products and services
Receive some products
Mandate regulatory requirements
Provide candidates for hiring - conduct initial vetting of candidates
Provides our raw materials and critical support services
Has direct responsibility for management of the company
11
 Issues of Concern

COTO Log: Issues List Rev. 0

Ln Interested Party Issue of Concern Type of Issue Bias Treatment Method Record Reference / Notes
1 CPA Concerned with company's accounting practices Internal Risk Undergo regular financial audits Legal records (confidential)
2 Certification Body Level of compliance to ISO 9001 External Mixed See Appropriate Register See audit records
3 Attorney Concerned with company's legal compliance Internal Risk Confer with counsel as needed to maintain legal Financials (confidential)
compliance
4 Direct Customer Expect high quality products External Risk See Appropriate Register
5 Direct Customer Expect on time delivery External Risk See Appropriate Register
6 Direct Customer Could be source of referrals to new customers External Opportunity See Appropriate Register
7 Direct Customer Flows down their QMS requirements External Risk See Appropriate Register
8 Direct Customer If happy, could expand current business External Opportunity See Appropriate Register
9 Direct Customer Expect good customer support External Risk See Appropriate Register
10 Employee / Staff Expect to be compensated Internal Risk See Appropriate Register
11 Employee / Staff Expect satisfactory equipment, facilities Internal Risk See Appropriate Register
12 Employee / Staff Require appropriate training Internal Risk See Appropriate Register
13 Local Community Have concerns over property and nearby land External Risk Maintain good relations with local community
14 Local Community Wants our company to hire and retain local workers External Risk See Appropriate Register
15 Local Community Can provide positive press External Opportunity See Appropriate Register
16 Product End User Expect high quality products External Risk See Appropriate Register
17 Product End User Expect on time delivery External Risk See Appropriate Register
18 Public Expect high quality products External Risk See Appropriate Register
19 Public Expect on time delivery External Risk See Appropriate Register
20 Public Concerned with safety of the product External Risk See Appropriate Register
21 Regulatory Bodies Must comply with all regulations and statutes External Risk See Appropriate Register
22 Staffing Agencies Concerned with reputation of our company as a employer External Risk See Appropriate Register
23 Staffing Agencies Must provide adequate candidates External Risk See Appropriate Register
24 Supplier Expect to be paid promptly External Risk See Appropriate Register
25 Supplier Require clearly defined requirements External Risk See Appropriate Register
26 Supplier Require adequate notice of rush jobs External Risk See Appropriate Register
27 Supplier Vendor performance impacts on our reputation External Mixed See Appropriate Register
28 Supplier Supplier does not want us to damage or lose their material External Risk See Appropriate Register
29 Supplier Have concerns that we may impact on their reputation External Risk See Appropriate Register
30 Top Management Company must remain financially healthy Internal Risk Management to maintain healthy financials Financials (confidential)
31 Top Management QMS processes must be efficient Internal Risk See Appropriate Register
32 Top Management Concerned with growth of company Internal Risk Management review activities Management Review Records
33 Top Management Company must maintain sufficient staff Internal Risk See Appropriate Register
34 Top Management Requires reliable equipment and facilities Internal Risk See Appropriate Register
35 Direct Customer Wants us to protect their property External Risk See Appropriate Register
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Ln Interested Party & Issue
# (From prior tabs)

1 Direct Customer: Expect high quality products

2 Direct Customer: Expect high quality products
3 Direct Customer: Expect high quality products
4 Direct Customer: Expect high quality products
5 Direct Customer: Expect on time delivery
6 Direct Customer: Expect on time delivery
7 Direct Customer: Expect on time delivery
8 Direct Customer: Flows down their QMS requirements
9 Direct Customer: Flows down their QMS requirements
10 Direct Customer: Expect good customer support
11 Top Management: Requires reliable equipment and facilities
12 Top Management: Requires reliable equipment and facilities
13 Employee / Staff: Require appropriate training
14 Employee / Staff: Require appropriate training
15 Direct Customer: Expect high quality products
16 Supplier: Vendor performance impacts on our reputation
17 Regulatory Bodies: Must comply with all regulations and statutes
18 Employee / Staff: Expect to be compensated
19 Supplier: Require adequate notice of rush jobs
20 Top Management: QMS processes must be efficient
21 Top Management: QMS processes must be efficient
22 Top Management: QMS processes must be efficient
23 Top Management: QMS processes must be efficient
24 Top Management: Company must maintain sufficient staff
25 Local Community: Wants our company to hire and retain local workers
26 Top Management: Requires reliable equipment and facilities
27 Top Management: Requires reliable equipment and facilities
28 Top Management: Requires reliable equipment and facilities
29 Top Management: Requires reliable equipment and facilities
30 Top Management: Requires reliable equipment and facilities
31 Top Management: Requires reliable equipment and facilities
32 Certification Body: Level of compliance to ISO 9001
33 Top Management: Requires reliable equipment and facilities
34 Direct Customer: Expect high quality products
35 Direct Customer: Expect high quality products
36 Direct Customer: Expect high quality products
37 Direct Customer: Expect high quality products
38 Direct Customer: Wants us to protect their property
39 Top Management: Requires reliable equipment and facilities
40 Supplier: Require clearly defined requirements
41 Top Management: Concerned with growth of company
42 Staffing Agencies: Concerned with reputation of our company as a employe
43 Staffing Agencies: Must provide adequate candidates
44 Supplier: Supplier does not want us to damage or lose their material
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COTO Log: Risk Register Rev. 0
Probability (of risk occurring)
Specific Risk
Likelihood

Product damaged during internal handling

Employees ignore job documents; leads to quality problems
Errors in job documents leads to quality problems
Cross contamination issues during manufacture lead to quality problems
Supplier delays cause late shipment
Raw materials are ordered late, putting delivery at risk
Customer pulls in delivery date
Customer QMS requirements cannot be met by our company
Customer QMS requirements cannot be met by supplier(s)
We provide poor support, harming our reputation
Poor equipment, facilities risk safety of employees
Poor equipment, facilities make it harder for employees to satisfy quality
Our training is inadequate, leads to human error
Training is not provided where needed, resulting in poor quality
Product does not work as required or expected once installed
Our vendor's reputation harms our own reputation in some way
Products fail required regulatory testing
Failure to make payroll
Failure to notify supplier of rush job requirements
One or more processes fail to meet KPI or process objectives
Internal audits fail to identify process problems, nonconformities
Process metrics are not sufficiently related to customer expectations
External audits reveal serious process nonconformities
Loss of single key employee
Insufficient talent pool in the area leads to hiring gaps
Fire
Theft, break-in / loss of equipment or product
Extreme weather event leads to company shutdown of > 24 hours
Hack / virus / ransomware / phishing scams
IT: loss of records backup
IT: Catastrophic server failure
Loss of ISO 9001 certification due to ISO 9001 audit failure
Employee theft of equipment or materials
Equipment failure impacts on product quality/delivery
Poor quality outside processing
Improper packaging results in shipping damage
Poor raw material leads to quality problems
Loss or damage to customer/supplier property (physical)
Calibrated device found to be out of tolerance
Errors in outgoing Purchase Orders lead to supplier mistakes
Loss of top tier customer could impact on revenue suddenly
Staffing agencies "fire" us due to our poor reputation w/ employees
Staffing agencies fail to provide quality candidates for hiring
We lose or damage supplier-owned equipment or materials
obability (of risk occurring)
Prob. Potential Loss ot
Previous Occurrences Rating Customer or Entire
Contract
Consequence (if risk is encount
Potential Inability to
Potential Risk to Human
Meet Immediate Job
Health
Requirements
ence (if risk is encountered)
Cons. Risk Factor
Potential Violation of Impact on Company Est. Cost of Correction / Rating (Prob x Cons)
Regulations Reputation Financial Penalty
 Mitigation Plan
(Required for risk factors >=8,
suggested for risk factors between 5 and 8)
Ln Interested Party & Issue
# (From prior tabs)

1 Direct Customer: Could be source of referrals to new customers

2 Direct Customer: If happy, could expand current business
3 Local Community: Can provide positive press
4 Certification Body: Level of compliance to ISO 9001
5 Supplier: Vendor performance impacts on our reputation
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COTO Log: Opportunity Register Rev. 0

Specific Opportunity

We can develop ways to ensure customers refer us to new customers

We can increase efforts to have current customers increase their orders or work with us
We engage with local press to improve our reputation in the community
We obtain and retain ISO 9001 certification
The quality of our vendors allows us to piggyback on them, improving our reputation
Probability (of achieving the opportunity)
Prob.
Rating Potential for New
Likelihood Previous Occurrences Business
 Benefit (if opportunity is encountered)
Potential improvement
Potential Expansion of Potential improvement to internal QMS Improvement to Potential Cost of
Current Business in satisfying regulations Company Reputation Implementation
processes
 Number of active improvement activities:

Opportunity Pursuit Plan

Ben. Rating Opp Factor (suggested for Opp Factors >=12)
(Prob x Ben)
May reference external planning document
0

Status Post- Implementation

Success?
 OPP RATING RATING: RISK RATING LIMIT: Type Priority
12.0 8.0 External Emergency
RISK CONSIDERATION LIMIT Internal High
5.0 Medium
Low

Opportunity Trend Data

Number Open Improvement Initiatives 0
Number Closed Improvement Initiatives Customize
0 these as you like.
Total Improvement Initiatives to Date 5
Opportunity Failed
The
0
Risk Rating Limit is the minimum risk score which will trigger a
MANDATORY mitigation plan.
Opportunity Abandoned 0
Met some expectations The
0 Risk Consideration Limit is a score which would trigger a
SUGGESTED mitigation plan.
Met all expectations 0
Exceeded expectations The
0 Opportunity Rating Limit is the minimum score which would
require a mandatory "opportunity pursuit plan."

Risk Trend Data

Total risks processed 44

Total risks requiring action 0

This area provides some simple data on risks and opportunities which you
Total risks suggesting action 44
can incorporate into your Management Review activities.
Total risks accepted without action 0
 Treatment Bias Likelihood
No Action: Accept Risk per Mgmt Decision Opportunity Cannot occur / not applicable
See Appropriate Register Risk Unlikely to occur
Root Cause Analysis Mixed Somewhat likely to occur
Internal Auditing Likely to occur
Root Cause Analysis Very likely to occur
Corrective Action Request (CAR)
Vendor Auditing
Other Auditing
Management Review Activity
Marketing Enhancement
Other
which will trigger a

ould trigger a

core which would

le data on risks and opportunities which you

nagement Review activities.
 Occurrences Potential Violation correction reputation cost of opp
Has never occurred. None / NA None / NA $ 0 or N/A None > $500,000
Has not occurred in past 10 years. Minor Possible < $10,000 Minimal > $100,000
Has occurred in past 10 years. Moderate Definite < $100,000 Moderate < $100,000
Has occurred in past 5 years. High High > $100,000 Severe < $10,000
Has occurred in past year. Very High Legal Risk > $500,000 Very severe $ 0 or N/A

Customize your dollar limits here,

if you like. This will automatically
reverse-populate Column Q at the
same time.
 reputation score Success
No impact / NA 1 Opportunity Failed
Minimal impact 2 Opportunity Abandoned
Moderate impact 3 Met some expectations
Good impact 4 Met all expectations
Great impact 5 Exceeded expectations

llar limits here,

automatically
olumn Q at the
(Required for risk factors >=
,
suggested for risk factors between
(Required for risk factors >=8,
suggested for risk factors between 5 and 8)

Opportunity Pursuit Plan

(suggested for Opp Factors >=
)
May reference external planning document
(suggested for Opp Factors >=12)
May reference external planning document