Common Engineering Abbreviations

ADL

audit of device label

ATR

age test record

BOM

bill of materials

BSC

build schedule compliance

CAPA

corrective action preventative action

CMR/ED

carcinogenic, mutagenic, reprotoxic/endocrine disrupting

dFMEA

design failure mode and effect analysis

DHF

design history file

DHR

device history record

DMR

device master record

EU MDR

european union medical device regulation

FG

finished good

FIFO

first in first out

GDP

good documentation practices

HMID

hazardous material information for devices

HR x HR

hour by hour (board)

IFU

instructions for use

SKU

The orderable number assigned to a product marketed by STERIS. This is also called the Oracle Item Number, Equipment Number, Re-order Number, Price book number, Product Code, or Item Number. Represented on the label using the harmonized symbol REF.

IOS

input output specification

IQ

installation qualification

JIB

job instruction breakdown

JSA

job safety analysis

LHR

lot history record

LNR

lot not required

MB

material biocompatibility

MC

manufacturing center

ME

manufacturing engineer

PE

process engineer

NC(R)

nonconformance (report)

NCMA

nonconforming material area

NPD

new product development

OQ

operational qualification

PLM

product lifecycle management

PMS

post market surveillance plan

PPR

post production report

PQ

performance qualification

QA

quality assurance

QC

quality control

QE

quality engineer

QMS

quality management system

RMP

risk management plan

RMR

risk management report

RTM

risk traceability matrix

SCAR

supplier corrective action request

SOP

standard operating procedure

SQDC

safety, quality, delivery, cost

sub

subassembly

SWIP

standard work in process

TWI

training within industry

USE

US endoscopy

WI

work instruction

WIP

work in process