Risk Management Input Compiled 20170207.xlsx 

National Assessment Submitted After Risk Management Training in 2015 

Data Compiled 2/7/2017 

Current 17025 Section Number 

Identify an event or hazard that COULD impact the quality of the 

laboratory measurement or test results. Combined Controls Probability Impact 

4.1 Organization Loss of Trained Laboratory Personnel None 5% 100% 

4.1 Organization Weights marked as in tolerance when actually out Code of ethics of employer 1% 75% 

4.1 Organization 

A metrologist is allowing weights to be marked as in tolerance when out 

of tolerance to save a customer money 

As a part of the state organization, the metrologist is 

bound to the code of ethics and may be terminated 10% 70% 

4.1 Organization Loss of one or more trained metrology staff 

Cross train current metrology staff, Succession 

planning, Early hiring when possible to train with exiting 40% 50% 

4.1 Organization Out of date organizational chart Annual audit, Scheduled document review 30% 5% 

4.1 Organization 

The Lab is under the Dept of Agriculture, Quality Assurance Division, 

Measurement Standards Branch but requires funding from the State 

general fund to operate and function. 

The management of the Dept of Agriculture submits 

testimony on the impact of the Weights and Measures 

program and usually gets the funding for the 

Measurement Standards Branch. Once in a while, 

when the State budget is tight, the funds are restricted 

and cuts to the Branch operating budget and personnel 

are implemented. 15% 90% 

4.2 Management System Loss of management support 10% 100% 

4.2 Management System Laboratory QMS documents not updated or maintained 

Internal Audits, Management Reviews, External 

Assessments (NIST, NVLAP) 10% 60% 

4.2 Management System Not maintaining the QMS Scheduled annual review 1% 10% 

4.2 Management Systems 

A new ISO 17025 is updated and new requirements are added to the 

standard. 

p , q y 

manual and the quality management system will be 

also updated to reflect all of the new requirements. 

Internal audit will be completed to see if the 

requirements are met. 30% 20% 

4.3 Document Control Obsolete or not approved Documents could be used in the lab 

Documents must be dated and signed before being 

implemented into the quality system, Documents are 

reviewed periodically, Documents are reviewed as part 

of the Internal Audi, Documents are reviewed in Team 

Meetings 10% 50% 

4.3 Document Control Personnel are on an outdated document 

Annual Document review, Document control procedure, 

Annual quality audit, master list review 90% 30% 

4.3 Document Control 

Technician used outdated SOP for performing calibration work, The 

calibration was done incorrectly 

Quality Manual’s Master List that is used to state the 

current publications to be used, Prompts removal of 

outdated manuals and procedures 10% 25% 

4.3 Document Control Corrected calibration report AP to specify corrections to certificates 1% 15% 

4.3 Document Control Outdated master list Quality manager reviews library and documents desk 90% 10% 

4.3 Document Control Typo or miss identification of Calibration Reports 

Standard process for naming calibration reports based 

on date of measurement and metrologist, Peer Reviews 

of any new calibration report formats and wording, 

Double check of reports before sending/issuing 1% 10% 

4.3 Document Control Using an outdated document Scheduled review of documents 10% 8% 

4.3 Document Control 

An older version of a controlled document is use, instead of the newer 

version. 

Controlled documents are reviewed as needed or at 

least annually to prevent the use of older documents 

being used. The "HI Document Log" file is updated and 

lists the latest version of the document that is in use. 9% 50% 

4.4 Contract Review Scale truck not arriving Appointment confirmations sent to customers 3% 25% 

4.4 Contract Review Untrained employee speaking with customer OJT and familiarity with QMS 10% 10% 

4.4 Contract Review Lifting, electrical shock 

General ergonomic and office-related safety training, 

Properly wired and grounded equipment 10% 9% 

4.4 Contract Review 

A 5 gallon stainless steel test measure was tested using SOP 19 (volume 

transfer) instead of SOP 14. 

The SAP 3, contract review procedure would be 

reviewed. The customer would be contacted and be 

informed of the differences in calibration procedures, 

results and calibration costs. 15% 45% 

4.5 Subcontracting Using an unapproved subcontractor Using an approved subcontractor list 2% 68% 

4.6 Purchasing and Supplier Evaluation Purchased latex gloves from unapproved supplier Using an approved supplier list 7% 72% 

4.6 Purchasing and Supplier Evaluation Poor, incorrect, insufficient purchase orders 

Consistently work with known suppliers, SAP 15 for 

purchasing materials and outside calibrations 20% 60% 

4.6 Purchasing and Supplier Evaluation Supplies purchased for the lab are not suitable 

Purchase supplies that are known good, Assess the 

supplies for suitability when they arrive, but before use 10% 51% 

4.6 Purchasing and Supplier Evaluation 

Invalidated supplies may not meet the required specifications for the 

application of use 

Purchasing reagent grade supplies for a approved 

vendor only, Testing quality of the supplies upon use 1% 50% 

4.6 Purchasing/ Supplier Evaluation 

Supplier evaluation was not done on a purchase of a standard or 

equipment 

Supplier evaluations are done prior to any purchase to 

see if the supplier is accedited and the purchased item 

will meet all of the criteria and requirements needed. 17% 50% 

4.7 Customer Service 

A survey monkey Customer Satisfaction survey was given to customers 

after calibration was completed. 

SAP 12, Complaint Resolution is reviewed. All positive 

and negative feedback from customer surveys are 

reviewed. Complaints and Corrective actions are 

documented and reviewed in the management reviews. 5% 25% 

4.7 Service to the Customer A customer brings in more artifacts than what they are scheduled for 

Having a documented schedule and appointment 

confirmation system, Using a laboratory policy on 

unscheduled items 7% 22% 

Risk Mgmt by 17025 Sections Page 1 of 5 
 

Risk Management Input Compiled 20170207.xlsx 

Current 17025 Section Number 

Identify an event or hazard that COULD impact the quality of the 

laboratory measurement or test results. Combined Controls Probability Impact 

4.7 Service to the Customer 

472 ; If customer feedback is not solicited and reviewed, the laboratory 

risks losing the business of the customers who feel ignored The 

overlooked issues could also impact other customers having the same 

issue 

Conduct phone surveys randomly throughout the year 

Ask questions that are on the customer feedback form 

and document the responses, Customer feedback form 

is on laboratory's website and can be populated and 

submitted on-line The link to the survey page is 

included in the signature of lab staff emails, Customer 

feedback is reviewed twice per year during 

management review meetings 10% 20% 

4.7 Service to the Customer Client skeptical of test results provided by the laboratory 

Client permitted controlled access to laboratory to 

observe retesting of the artifact(s) 10% 20% 

4.7 Service to the Customer 

Customer requests to observe how his or her 5 gallon test measure is 

calibrated 

The customer is permitted controlled access to the 

volumetric laboratory to observe the calibration 

procedure 5% 5% 

4.7 Service to the Customer Client requests to observe 5 gal TM being calibrated 

Client permitted controlled access to volumetric testing 

area by metrologist 20% 5% 

4.8 Complaints 

If complaints are ignored, potential corrective / preventative / 

improvement actions will be missed and customers may be lost 

Complaints (internal and external) are initiated through 

the laboratory's website Complaints entered in the 

website are automatically transferred to the laboratory's 

metrology database for immediate review by 

appropriate lab staff, 100% of customer complaints 

result in C/P/I action as appropriate 10% 70% 

4.8 Complaints No records of complaints recorded Use of the laboratory’s policy on complaint handling 1% 13% 

4.8 Complaints Complain to management instead of the laboratory Customer survey form with laboratory's phone no 10% 9% 

4.8 Complaints 

A customer calls in a complaint that he needs his standard calibrated by 

tomorrow. 

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and root cause analysis is performed. Customer 

complaints are handled in a important and courteous 

manner. 10% 30% 

4.9 Control of Non-conforming Work Non-conforming work is performed 

Procedure for departure from documented policies and 

procedures 1% 69% 

4.9 Control of Non-conforming Work knowingly not recalling work when necessary 

QM section 49 addresses this issue, SAP 21 addresses 

this issue, Trained staff to follow procedures in QM and 5% 30% 

4.9 Non-Conforming Control 

Control chart on a check standard weight seems to be drifting out of 

control. 

SAP 17, Error and Non-conforming work procedure 

would be reviewed. Root cause analysis would be 

performed. The balance would be check to see if any 

calibration was needed. The check standard would be 

checked for any instabilities. The facilities and 

environment would be checked for any instability. 20% 50% 

4.10 Improvement 

5-gallon test measures were heavy to lift up to the 36 in high sink during 

calibration. 

The Lab improvement uses a thork lift to carry up the 5-

gallon test measures to do the 30 second pour and 10 

second drain for calibration. 17% 30% 

4.10 Improvement Action Areas of the laboratory are not evaluated for improvement 

Periodic review of different areas of the laboratory for 

improvement, Periodic review of customer needs 4% 50% 

4.10 Improvement Action Not completing corrective actions identified in audits 

Scheduled follow-up meeting as a part of our internal 

audit schedule to review actions 10% 50% 

4.11 Corrective Action Corrective Action is not done or not complete 

Corrective Action Form, Tasks are assigned to personnel 

to investigate the cause, Due Dates are set to achieve 

the goals of the corrective action, Corrective Actions are 

reviewed after implementation to validate the 

resolution of the corrective action, Measurement 10% 50% 

4.11 Corrective Action 

Use of outdated publication resulting in outdated SOP calibration being 

used 

Periodic Review of Master List, Assign responsibility for 

maintaining periodicals/publications , Perform internal 

audit of publications and storage 25% 40% 

4.11 Corrective Action Corrective actions improperly recorded 

Use laboratory policies and procedures for corrective 

action 8% 13% 

4.11 Corrective Action 

Power surges in the electrical system in the Lab happen periodically and 

may harm the balances that are connected to the wall outlets 

The Lab used corrrective action and has purchased 

APC battery back up and surge protectors to protect all 

balances and computers from electrical surges and 

power failures. 25% 30% 

4.12 Preventive Action Sources of nonconformities are nor identified. 

The policy of the Lab is to use preventive action and 

identify nonconformities and improvements to prevent 

sources of nonconformities. Root cause analysis is 

done to identify the cause of the nonconformity. 18% 30% 

4.12 Preventive Action A piece of equipment vital to laboratory operations is not maintained Schedule for maintenance of equipment 15% 83% 

4.13 Control of Records 

The laboratory computer files are destroyed due to a computer hard drive 

failure 

The computer files for the Lab are backed up daily on 

to a flash drive and copied to all Laboratory computers 

and laptops. 13% 45% 

4.13 Records Unauthorized access to office, files, computer system 

Site security, keypads, door locks, External data backup procedures (shared server), computer passwords, 20% 80% 

4.13 Records Records not kept in a secure manner Laboratory procedure on record control 1% 73% 

4.13 Records 

Records and documents on your computer could be erased or destroyed 

if your computer doesn't work one day 

the lab files are backed up on a flash drive every day at 

the end of work , The computer lab files are on three 

separate computer hard drives, lab reports and other 

documents are printed (hard copy) 10% 70% 

4.14 Internal Audits The laboratory failed to complete an internal audit of its activities 

Audits scheduled ahead of time to ensure they are 

completed 1% 93 % 

Risk Mgmt by 17025 Sections Page 2 of 5 
 

Risk Management Input Compiled 20170207.xlsx 

Current 17025 Section Number 

Identify an event or hazard that COULD impact the quality of the 

laboratory measurement or test results. Combined Controls Probability Impact 

4.14 Internal Audits Facilities audit finds no humidity controls in large volume area 

Deviation to requirements authorized after study, No 

calibration performed during time when outside 

requirements 25% 10% 

4.14 Internal Audits Internal audits are not done for areas in the quality management system. 

The internal audits are scheduled and completed 

before the NISTannual submission for recognition. 28% 20% 

4.14 Internal Audits Whole host of items are rendered obsolete because not being monitored. 

Internal audit performed at a min. of twice a year (more 

than requirement of once). Employees take turns with 

different sections of HB 143 to eliminate bias. Split up 

internal audit into "chunks" to prevent rubber stamping 

of items in checklist. Have weekly meetings/roundtable 

to discuss set topics for review. 60% 60% 

4.15 Management Reviews Incomplete management review 

Covered in QM section 415, Covered in SAP 18, Trained 

staff on using QM and SAP's, Peer review, 5% 30% 

4.15 Management Reviews 

The management review is missing some of the information that should 

be included in it 

A checklist of the items required in the management 

review 4% 30% 

4.15 Management Reviews 

During the management review meeting, we failed to discuss and address 

a failed proficiency test 

A check list is used to make sure that all topics are 

addressed and covered 5% 5% 

4.15 Management Reviews Failure to discuss failed PT during Management Review meeting 

Checklist used to insure that all topics are addressed 

and discussed 5% 5% 

4.15 Management Reviews The management review is missing a few topics for discussion. 

The format of the management review has an outline 

form for all topics for discussion with top management. 8% 30% 

4.15 Management Reviews Old obsolete equipment being used. 

Increased management review meetings from once to 

twice a year. provide very detailed information in review 

- to solicit upper management of "buy-in". Weekly 

meetings to discuss/share ideas and comments 

regarding lab operations. Require all laboratory 

personnel to attend, as well as bureau director. 

Maintain a dry erase board - allow all employees to 

write down ideas for later discussion. Available 365 40% 50% 

5.1 General Laboratory not kept clean Regular cleaning of the laboratory 6% 35% 

5.2 Personnel New metrologist (or other new staff) Damage to standards 10% 95% 

5.2 Personnel An employee leaves the laboratory Plan for replacement of employees 8% 93 % 

5.2 Personnel Retirement of only metrologist Can hire one year before retirement 90% 76% 

5.2 Personnel 

Only one metrologist in Lab. The Lab would shut down if the metrologist 

position were vacant (no metrologist in Lab) 

The State policy is that due to budget restaints, 

management cannot hire another metrologist for the 

Lab unless the metrologist leaves or the position is 

vacant. Usualy time to fill the metrologist position is a 

year or more and three years to get fully trained to open 

at Echelon III (legal metrology capable). 20% 80% 

5.3 Facilities and Accommodations The Air conditioner in the Lab goes out due to electricity failure 

the lab balances are hooked to an APC battery back up, 

the lab calibration is stopped if the environment is out 

of HB 143 specifications, the AC is turned back on when 

the electricity turns on, the environment in the Lab is 

monitored 24/7 for temp and humidity, 30% 50% 

5.3 Facilities and Accommodations Environmental conditions go out of control in a laboratory room 

HVAC system regularly maintained and environmental 

conditions recorded 18% 50% 

5.3 Facilities and Accommodations Electrical power into the lab fluctuates 

Surge protectors on all balances, Control charts to 

monitor process 60% 15% 

5.3 Facilities and Environment 

The AC goes off due to electrical failure. Environment goes outside HB 

143 guidelines. 

The Laboratory balances are hooked to a APC battery 

back up to prevent damages from electric surges. The 

AC is reset as soon as possible when the electricity is 

turned on. All calibrations are put on hold until the HB 

143 environmental guideline are met for at least 24 

hour period. 30% 30% 

5.4 Calibration Methods A calibration method is developed but not validated Method validation procedure 4% 22% 

5.4 Calibration Methods 

A new standard come into the Lab and there are no calibration methods 

stated. 

The laboratory will contact the customer to inquire on 

the use of the standard in the field and the prefered 

calibration method that should be used. 22% 10% 

5.4.6 Measurement Uncertainty Uncertainty budget missing Uncertainty budget reviewed and added to method 1% 75% 

5.4.6 Measurement Uncertainty 

An incorrect standard deviation of the process was used the calculate the 

uncertainty due to insufficient amount of trial runs. 

The uncertainty SOP 29 will be reviewed to see 

whether any more componets to the uncertainty could 

be added. The reported uncertainty and the level of 

confidence (k) would need to be changed and 

documented on the calibration report. More trial runs 

using a check standard would need to be done to get a 

better and reliable s(p) use in the uncertainty. 10% 40% 

5.5 Equipment 

A balance has been overloaded or a weight dropped on it causing erratic 

readings 

Training on proper handling and use of standards and 

balances 1% 74% 

5.5 Equipment Balance goes down w/ no backup 

annual balance maintenance, staff training on balances 

before allowed to use 35% 60% 

5.5 Equipment 

Damaged proving ring due to high humidity level in the lab in a specific 

day of 2015 

Visual inspection (to verify area and degree of rust) , 

Analysis of results from equipment (to verify if damage 

caused changes in results) 20% 55% 

Risk Mgmt by 17025 Sections Page 3 of 5 
 

Risk Management Input Compiled 20170207.xlsx 

Current 17025 Section Number 

Identify an event or hazard that COULD impact the quality of the 

laboratory measurement or test results. Combined Controls Probability Impact 

5.5 Equipment 

Pinching, crushing, falling, slipping, projectiles Trip hazard with cords, 

boards, and comparators in Large Mass Lab, minor pinch hazards with 

comparator doors, pinch and crush hazards with standards, slip hazards 

with wet floor in volume area 

Two-person requirement for testing weight carts, Safety 

and ergonomic training and equipment, PPE, Signage, 9% 40% 

5.5 Equipment 

The Mettler PK 36 balance is not working properly in calibrating 50 lb 

weights. 

The Lab has purchased a 64 kg mass comparator to 

replace the old PK 36 balance and will be installed in 

Sept 2016 25% 50% 

5.6 Traceability Standards calibrated by an outside laboratory with expired standards 

Supplier review and checks of standards ran to ensure 

values 1% 92 % 

5.6 Traceability 

A calibration laboratory has its reference standards calibrated by another 

laboratory whose reference standard's calibration is past its documented 

calibration interval Set Calibration interval, annual technical audit 5% 90% 

5.6 Traceability Transport and Storage of artifacts 

Cases, Training, Gloves/forceps, Clean room, 

Environmental controls 30% 70% 

5.6 Traceability uncertainties being too large from outside calibration svc HB 143 guidelines, Mid Map risk assessment training 50% 60% 

5.6 Traceability 

The Lab receive a calibration for a temperature/ humidity device from a 

Company the is not traceable to NIST. 

The Lab will check the supplier evaluation list and 

check the accreditation and traceability status of all 

companies that calibrate equipment for the Lab. SAP 

11, Purchasing anf Supplier Evaluation procedure 

would require that the vendor be accredited and 

traceable to NIST. 11% 30% 

5.7 Sampling Selection of a sample not performed correctly Use validated procedures for sampling 1% 26% 

5.8 Storage and Handling bad handling of customer standards 

notify to the customer of the importance of proper 

handling of the standards, notify to the customer the 

impact that will have to his process, give a training of 

storage and handling of the standards 55% 76% 

5.8 Storage and Handling A customer’s artifact goes missing 

Inventory tracking procedures and materials used in 

laboratory 1% 73% 

5.8 Storage and Handling 

A customer item is lost and your lab is liable for the reimbursement to the 

company 

Chain of custody and procedures to ensure secure 

handling 5% 70% 

5.8 Storage and Handling 

Weight could "come loose" in shipment, damaging the weight (or 

weights) 

Pack the weights properly using appropriate materials 

to restrict their movement 36% 70% 

5.8 Storage and Handling Damage/Contamination Quality Manual section in handling artifacts 10% 60% 

5.8 Storage and Handling Improper/Poor handling of weights 

Handling procedures in QM, SAP 11, Separate forceps 

labeled for standards and customers weights, Control 

charts - could show handling mishaps of standards and 

check standards, Highly polished standards to show any 

scratches or smudges, 10% 25% 

5.8 Storage/ Handling 

The Lab receives a weight kit and the weights are all over upside down 

and mixed up inside the case, because the foam holders were old and 

damaged. 

The lab will review and follow the SAP 4, Handling 

Calibration and Test Items. The weights in the case 

will be removed individually and inspected for any 

damages. The lab will document the as found 

condition of all the weights and let the customer know 

of any damages before calibration is done. 7% 50% 

5.8 Storage and Handling Artifacts are damage in receipt to the lab or shipment to the customer. 

Laboratory staff are properly trained in the process of 

safely packing and shipping weights. Customers are 

informed of proper shipping practices on our 

laboratory's work request form. 25% 65% 

5.9 Measurement Assurance The working standard was accidently switched with a customer's artifact 

The use of a check standards, control chart, and our 

participation in proficiency tests would flag this 5% 100% 

5.9 Measurement Assurance Working Standard accidentally switched with client's artifact 

Use of Check Standards and Control Charts , 

Participation in Proficiency Tests 20% 76% 

5.9 Measurement Assurance Recalibration of Items 

Recall dates, Database of items, Stickers on items, Dates 

on Certificates, 10% 70% 

5.9 Measurement Assurance Check standard value not logged Procedure for performing calibrations and checks 1% 49% 

5.9 Measurement Assurance 

The control charts were not properly updated real time. Standard 

deviation of the process have small df and k values. 

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time, so as to obtain a current standard deviation of the 

process along with the current df and k value. The 

control charts are updated for all mass and volume 

calibrations. 12% 45% 

5.9 Measurement Assurance Check standard measurements go out of control. 

Check standard measurements are made each time 

measurements are being performed at its nominal 

value; or check standard measurements are made even 

more frequently. All standards are stored in stable, safe 

locations to prevent damage. Laboratory has a cleaning 

and maintenance schedule for equipment such as 

balances and enviromental instruments. 15% 60% 

5.10 Reporting (Certificates) Errors published in report to customer 

Double check all entries in report, Use excel to monitor 

for possible errors 35% 15% 

5.10 Reporting (Certificates) Incorrect procedure referenced on a calibration report 

Have separate calibration report templates for different 

procedures 1% 5% 

Risk Mgmt by 17025 Sections Page 4 of 5 
Risk Management Input Compiled 20170207.xlsx 

Current 17025 Section Number 

Identify an event or hazard that COULD impact the quality of the 

laboratory measurement or test results. Combined Controls Probability Impact 

5.10 Reporting/ Calibration Reports 

The Lab finds an error in the calibration report after the items were 

returned to the customer. 

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Error and non-conforming work procedure would be 

reviewed. The customer would be contacted and a 

revised and amended calibration report would be 

issued. 5% 40% 

Safety or Security 

Security-Unauthorized personnel in the Laboratory damaging standard or 

balance 

Authorized lab personnel identified, Outside of building 

kept locked, Testing rooms locked, Keys given out to 

only authorized personnel, The number of authorized 

personnel kept to a minimum 20% 60% 

5.9 Measurement Assurance Check standard measurements go out of control. 

Check standard measurements are made each time 

measurements are being performed at its nominal 

value; or check standard measurements are made even 

more frequently. All standards are stored in stable, safe 

locations to prevent damage. Laboratory has a cleaning 

and maintenance schedule for equipment such as 

balances and enviromental instruments. 15% 60% 

Risk Mgmt by 17025 Sections Page 5 of 5