Acronyms Flashcards

1
Q

AOP

A

Annual operating plan; refers to the budget

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2
Q

AQL

A

Acceptable Quality Limit; sampling plans for incoming inspection

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3
Q

ASL

A

Approved supplier list

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4
Q

CFN

A

Customer facing number

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5
Q

CTQ

A

Critical to quality; feature that influences patient safety

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6
Q

DC

A

Distribution center

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7
Q

DCH

A

Data change order; agile MAP

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8
Q

DRM

A

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

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9
Q

EID

A

Engagement in Inclusion and Diversity

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10
Q

EU MDR

A

Medical device regulation

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11
Q

FCA

A

Field corrective action

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12
Q

FIRE board

A

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

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13
Q

FMEA - D, P, U

A

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

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14
Q

IFU

A

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

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15
Q

IMD

A

Inventory management dashboard

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16
Q

IIA

A

Issue impact assessment

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17
Q

IQ

A

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

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18
Q

IQA

A

Incoming quality assurance

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19
Q

MAP

A

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

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20
Q

MOR

A

Monthly operations review

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21
Q

MFR (SCR context)

A

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

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22
Q

MOS

A

Medtronic operating system; framework for Lean Sigma tools

23
Q

MSA

A

Measurement system analysis

24
Q

NC

A

Non-conformance

25
Q

NCMR

A

Non-Conforming material record

26
Q

OHS

A

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

27
Q

OQ

A

Operational qualifications

28
Q

OOS

A

Out of specification results

29
Q

PCH

A

Product change order; agile MAP

30
Q

PCR

A

Product change request

31
Q

PHO

A

Product hold order

32
Q

PMM

A

Post Market Monitoring; FDA monitoring requirement for commercially available devices

33
Q

PPAC

A

Production part approval checklist

34
Q

PQ

A

Process Qualification

35
Q

PR

A

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

36
Q

PVVP

A

Process verification and validation plans

37
Q

QA (context with supplier docs)

A

Quality agreement

38
Q

QM

A

Quality module in SAP

39
Q

QPR

A

Quality performance review

40
Q

QSR

A

Quarterly site review

41
Q

RCH

A

Record change orders; agile MAP for doc changes

42
Q

RIR

A

Receiving inspection report

43
Q

RPM

A

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

44
Q

SAR

A

Supplier action request; smaller SCAPA

45
Q

SC (context of RPM board)

A

Steering committee

46
Q

SCAPA

A

Supplier corrective and preventative action

47
Q

SCR

A

Supplier change request

48
Q

SNT

A

Surgical navigation technologies; StealthStation S8

49
Q

SQE

A

Supplier quality engineer

50
Q

SOQ

A

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

51
Q

483

A

FDA form 483; used to document observations during an inspection

52
Q

VAVE

A

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

53
Q

COPE

A

Cost of poor execution, quality KPI