Abbreviation | Definition |
AMPAP | Aston Martin Part Approval Process |
APQP | Advanced Product Quality Planning |
AQL | Acceptable Quality Limit |
ARPN | Alternative Risk Priority Number |
Artifact | Measurement machine verification items |
Audit | Systemic independent and documented process for obtaining objective evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled |
CI | Continuous Improvement |
CM | Change Management |
Concession | Permission to use or release a product or service that does not conform to specified requirements |
Correction | Action to eliminate a detected nonconformity |
CT | Computed Tomography |
CTA | Critical To Assembly |
CTF | Critical To Function |
Deviation | Permission to depart from the originally specified requirements of a product or service prior to its realization |
DFM | Design For Manufacture |
DFMEA | Design Failure Mode Effect Analysis |
DN | Delivery Note |
ECR | Engineering Change Request |
EMS | Environmental Management System |
FAI | First Article Inspection |
Failure Cause | Set of circumstances that lead to failure |
Failure effect | Consequence of a failure, within or beyond the boundary of the failed item |
Failure mechanism | Process that leads to failure |
Failure Mode | Manner in which failure occurs |
FAIR | First Article Inspection Report |
FMEA | Failure Mode Effect Analysis |
Hazard | Potential source of harm |
IMDS | International Material Data System |
Intended use Intended Purpose | Use for which a product, process or service is intended according to the specifications, instructions and information provided by the manufacturer |
IPC | In Process Control |
ISIR | Initial Sample Inspection Report (it entails all dims from 2D drawing/ or the ones that are possible to measure) |
ISO | International Organisation for Standardisation |
IVD | In Vitro Diagnostic |
Life Cycle | Series of all phases in the life of a medical device, from the initial conception to final decommissioning and disposal |
Likelihood | Chance of something happening |
Manufacturer | Natural or legal person with responsibility for the design and/or manufacture of a medical device with the intention of making the medical device available for use, under his name, whether or not such a medical device is designed and/or manufactured by that person himself or on his behalf by another person(s) |
MDS | Material Data sheet |
Medical Device | Instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) |
MPO | Mould Process Optimisation |
MSDS | Material Safety Data sheet |
NCR | Nonconformance Report |
Nonconformance | Non-Fulfilment of a requirement |
NPI | New Product introduction |
Objective Evidence | Data supporting the existence or verity of something |
OEM | Original Equipment Manufacturer |
OOS | Out Of Specification |
PAW | Part Approval Warrant |
PFMEA | Process Failure Mode Effect Analysis |
PM | Project Manager |
PO | Purchase Order |
POL | Policy |
POR | Purchase Order Request |
PPAP | Production Part Approval Process |
PPIR | Prototype Part Inspection Report |
Procedure | Specified way to carry out an activity or a process |
Process | Set of interrelated or interacting activities that use inputs to deliver an intended result |
Protocol | Protocol in the context of FRP refers to a set of guidelines and procedures that establish agreement on information and control processes between FRP stakeholders, including the manufacturer, customer and supplier. |
PSW | Part Submission Warrant |
PT | Project Team |
QA | Quality Assurance |
QC | Quality Control |
QMS | Quality Management System |
RA | Risk Assessment |
Record | Document stating results achieved or providing evidence of activities performed |
Regrade | Alteration of the grade of a nonconforming product or service in order to make it conform to requirements differing from the initial requirements |
Release | Permission to proceed to the next stage of the process or to the process |
Repair | Action on a nonconforming product or service to make it acceptable for the intended use |
Residual risk | Risk remaining after risk control (3.21) measures have been implemented |
Rework | Action on a nonconforming product or service to make it conform to the requirements |
Risk | Combination of the probability of occurrence of harm and the severity of that harm |
Risk analysis | Systematic use of available information to identify hazards and to estimate the risk |
Risk assessment | Overall process comprising a risk analysis and a risk evaluation |
Risk estimation | Process used to assign values to the probability of occurrence of harm and the severity of that harm |
Risk evaluation | Process of comparing the estimated risk against given risk criteria to determine the acceptability of the risk |
Risk management | Systematic application of management policies, procedures, and practices to the tasks of analysing, evaluating, controlling and monitoring risk |
SC | Schedule Confirmation |
Scenario | Possible sequence of the specified conditions under which the system, item or process function are performed |
SDS | Safety Data Sheet |
SEDS | Single Entry Data System |
Severity | Relative ranking of potential or actual consequences of failure or a fault |
SOP | Standard Operating Procedure |
SPAP | Small Production Approval Part |
T | Trial |
TEM | Template |
Verification | Confirmation through the provision of objective evidence, that specified requirements have been fulfilled |
Reusable Packaging | Packaging that with no compromise to presentation can be used to pack parts/materials to Stakeholders |