Acronyms

Question 1

AOP

Answer 1

Annual operating plan; refers to the budget

Question 2

AQL

Answer 2

Acceptable Quality Limit; sampling plans for incoming inspection

Question 3

ASL

Answer 3

Approved supplier list

Question 4

CFN

Answer 4

Customer facing number

Question 5

CTQ

Answer 5

Critical to quality; feature that influences patient safety

Question 6

DC

Answer 6

Distribution center

Question 7

DCH

Answer 7

Data change order; agile MAP

Question 8

DRM

Answer 8

Design, reliability, and manufacturing; set of frameworks, best practices, and tools for product development

Question 9

EID

Answer 9

Engagement in Inclusion and Diversity

Question 10

EU MDR

Answer 10

Medical device regulation

Question 11

FCA

Answer 11

Field corrective action

Question 12

FIRE board

Answer 12

Field Issue Risk Evaluation; cross-functional board assesses patient risk

Question 13

FMEA - D, P, U

Answer 13

Failure modes and effects analysis - Design, Process, Use; PFMEA is owned by supplier quality

Question 14

IFU

Answer 14

Instructions for use; created by Technical Communications, user guide is an example

Question 15

IMD

Answer 15

Inventory management dashboard

Question 16

IIA

Answer 16

Issue impact assessment

Question 17

IQ

Answer 17

Installation Qualification; includes training, equipment install, outlets, calibration/preventative maintenance

Question 18

IQA

Answer 18

Incoming quality assurance

Question 19

MAP

Answer 19

Medtronic agile program; MAP agile is the enterprise document control system

Question 20

MOR

Answer 20

Monthly operations review

Question 21

MFR (SCR context)

Answer 21

Monthly functional review; similar content to a MOR just focused on SCR

Question 22

MOS

Answer 22

Medtronic operating system; framework for Lean Sigma tools

Question 23

MSA

Answer 23

Measurement system analysis

Question 24

NC

Answer 24

Non-conformance

Question 25

NCMR

Answer 25

Non-Conforming material record

Question 26

OHS

Answer 26

Organizational health score; measured with a survey 2x per year

Question 27

OQ

Answer 27

Operational qualifications

Question 28

OOS

Answer 28

Out of specification results

Question 29

PCH

Answer 29

Product change order; agile MAP

Question 30

PCR

Answer 30

Product change request

Question 31

PHO

Answer 31

Product hold order

Question 32

PMM

Answer 32

Post Market Monitoring; FDA monitoring requirement for commercially available devices

Question 33

PPAC

Answer 33

Production part approval checklist

Question 34

PQ

Answer 34

Process Qualification

Question 35

PR

Answer 35

Project record; issue in TrackWise, could be SCAPA, CAPA, or task PRs

Question 36

PVVP

Answer 36

Process verification and validation plans

Question 37

QA (context with supplier docs)

Answer 37

Quality agreement

Question 38

QM

Answer 38

Quality module in SAP

Question 39

QPR

Answer 39

Quality performance review

Question 40

QSR

Answer 40

Quarterly site review

Question 41

RCH

Answer 41

Record change orders; agile MAP for doc changes

Question 42

RIR

Answer 42

Receiving inspection report

Question 43

RPM

Answer 43

Released product management; steering committee manages sustaining eng budgets and resources

Question 44

SAR

Answer 44

Supplier action request; smaller SCAPA

Question 45

SC (context of RPM board)

Answer 45

Steering committee

Question 46

SCAPA

Answer 46

Supplier corrective and preventative action

Question 47

SCR

Answer 47

Supplier change request

Question 48

SNT

Answer 48

Surgical navigation technologies; StealthStation S8

Question 49

SQE

Answer 49

Supplier quality engineer

Question 50

SOQ

Answer 50

Supplier-owned quality; links supplier inspection data to Medtronic to eliminate redundant inspections

Question 51

483

Answer 51

FDA form 483; used to document observations during an inspection

Question 52

VAVE

Answer 52

Value analysis, value engineering - technique and validation method during early phase of product design and development

Question 53

COPE

Answer 53

Cost of poor execution, quality KPI