Glossary of Terms

 

Term

Abrvn

      Definition

Acceptance Number

Ac

The maximum number of Non-compliant Items or Non-compliant Criteria allowed in a sample before the Lot is deemed unacceptable, depending on selected Compliance Definition (CD). 

Acceptance Quality Limit (AQL)

AQL

Represents the highest long-term-average non-compliance level that the User is willing to accept*.

The software enables the AQL to be defined in two ways depending on User requirements; refer to Compliance Definition (CD).

* Selected for each Compliance Class where an Audit Plan is configured to assess Total Non-compliant Criteria / 100 Items.

Acceptance Sampling by Attributes (Criteria)

 

 

A statistical sampling process used to control the compliance level of continuously produced materials, goods, activities, etc. (Items) by accepting or rejecting Lots based on the total number of Non-compliant Attributes (Criteria) or Non-compliant Items found in a randomly inspected sample. It is through this continuous process of acceptance and rejection that the average long-term non-compliance level is maintained within the specified maximum limits (AQLs)

Audit Checklist

 

A list of compliance criteria used by an Auditor/ Inspector to record the results of an Item audit. Can be paper or screen-based.

Audit Level

AL

Operates in conjunction with Audit Severity to determine the relative amount of discrimination applied to an Audit; (i.e. sample size). The higher the Audit Level, the larger the Sample Size for a given Lot, and the smaller the risk of rejecting an acceptable Lot (Producer’s Risk) or accepting an unacceptable Lot (Consumer’s Risk).

 

Three basic Audit levels I, II and III can be selected. Level II is the default and is sufficient for most audit applications. Level I may be used when less discrimination (smaller sample) is needed, or Level III when greater discrimination (larger sample) is required. Four additional special levels, S-1, S-2, S-3 and S-4 may be used where relatively small sample-sizes are necessary and larger sampling risks can be tolerated.

Audit Plan

AP

Defines the parameters used by the software to monitor and control the compliance level of Items produced by a process, group or third –party.

Audit Plan Manager

APM

User authorised to configure allocated Audit Plans, create Audit Requests, perform Audits, add Auditor (Users) and other Audit Plan Managers

Audit Plan Register

APR

List of all Audit Plans registered on the system.

Audit Provider

 

An organisation, group or individual authorised to undertake Audits on specified Items assessed and Audit Plans. Auditor (Users) are associated with an Audit Provider; refer Auditor.

Audit Request

AR

Used to initiate and track an audit through the system. It contains information necessary for the Auditor to successfully carry out their compliance inspection responsibilities; including

  • Lot Size
  • List of Items in the Lot
  • List of Criteria assigned to Items in the Lot
  • Minimum Sample Size*


* For each Compliance Class where the Audit Plan is configured to measure Total Non-compliant Criteria per 100 Items

Audit Severity

AS

Operates in conjunction with the Audit Level to determine the level of audit (i.e. Sample Size) and rigor (i.e. Acceptance Number) applied to a Lot. There are three Audit Severity categories that can be assigned to an audit;

  • Normal - usually assigned when there is no evidence that the compliance level of produced Items is better or poorer that the specified AQL;
  • Tightened - usually assigned when there is evidence that the compliance level of Items is consistently poorer than the specified AQL;
  • Reduced - usually assigned when there is evidence that the compliance level of Items is consistently better than the specified AQL

The software automatically assigns an Audit Severity* to an Entity based on their previous Lot Sentencing results, and the “Switching Rules” outlined in the respective samples; (i.e. ISO 2859:1-1999). If needed, the Entity’s Audit Severity can be manually reset.

 

* For each Compliance Class where the Audit Plan is configured to measure Total Non-compliant Criteria per 100 Items

Audit Verdict

AV

Indicates whether the total number of Non-compliant Criteria or Non-compliant Items found in a sample for a particular Compliance Class exceeds the Acceptance Number (Fail), or is equal or falls below the Acceptance Number (Pass).

Audit/ Inspection

 

Includes activities such as measuring, examining, testing or gauging one or more Criteria assigned to an Item, and comparing the results with specified requirements to establish whether acceptable compliance has been achieved.

Auditor (User)

 

Organisation, group or individual charged with the responsibility of conducting an audit. Only one Inspector can be assigned to each Audit Request.

Compliance Class

CC

Used to categorise Criteria into three risk consequence classes (only if Compliance Definition (CD) = “Total Non-compliant Criteria per 100 Items”);

  • Class Critical = renders Item hazardous, potentially hazardous or adversely affected usage;
  • Class High = considered to be of the next highest importance or risk;
  • Class Medium = considered to have the next lower degree of importance or risk.

A separate AQL is assigned to Compliance Classes “High” and “Medium” to ensure the more important or higher risk Criteria are more tightly controlled. “Critical” Criteria are always assigned an AQL = 0.

Compliance Definition

CD

The AQL definition that an Audit Plan will use to assess the compliance level of continuously produced Lots and evaluate the performance of responsible Entities

  1. TotalNumber of Non-compliant Criteria per 100 Items (TNCC)
  2. Percentage Non-compliant Items (PNCI)

Compliance Inspection

 

(See Audit)

Compliant Item

 

An Item with zero non-compliant Criteria.

Consumer

 

An organisation, process, person or group of people for which an Item is produced (refer to Entity).

Consumer’s (Entity’s) Risk Quality

CRQ

Quality (compliance) level at which 10% of Lots will be expected to be accepted.

Criteria

Cr

A characteristic or feature of an Item to be inspected. Used to determine the Item’s compliance with user requirements: e.g. length, volume, temperature, colour, process conformance, design conformance, etc.

Criteria Register

CrR

A register of criteria which have been assigned to Items or independently created and stored for future assignment to existing and new Items.

Critical Non Compliance

CNC

Indicates the presence of an “extreme” risk. This type of non-compliance identifies an unacceptable level of safety or operational hazard. Accordingly, its AQL is always set to zero (0%) by the software.

Entity

 

An organisation, process, group or third-party responsible for producing or supplying Items.

Item

 

Can include any of the following produced by or supplied by a process (internal or external);

  • A physical item;
  • A defined quantity of material;
  • A service, an activity, or a process; or
  • A combination of the above.

Lot

 

A quantity of Items from which a Sample is randomly selected for Audit. Lots are used to separate an Entity’s process into defined quantities of Items for sampling, audit and sentencing. Lots can contain any combination of Items provided they have been produced under essentially the same conditions and timeframe.

Lot Sentence

 

Indicates whether the sampled Lot is of an acceptable compliance level (i.e. Accept); or not (i.e. Reject).

Lot Size

N

Number of Items in a Lot.

Non-compliant Criterion

NC

A Criterion which does not comply with user-specified requirements.

Non-compliant Item

NCI

An Item with one or more non-compliant criteria.

Percent Non Compliance

PNC

One hundred times the total number of Non-compliant Items or Non-Compliant Criteria in a Sample divided by the total number of Items, or Criteria, in the sample; respectively.

Producer’s (Entity) Risk

PRK

The risk (probability) of the Audit Plan rejecting a Lot with a Compliance Level = AQL

Quality

 

Fitness for purpose. A measure of how an Item fulfils its Criteria.

Omitted Lot (Audit Request)

 

A Lot (Audit Request) that has been excluded from the Audit Severity switching process. Resubmitted Lots and Lots audited out of creation sequence are automatically “omitted” by the software.

Resubmitted Lot

 

A Lot which having been previously rejected and satisfactorily treated, is resubmitted for audit. Audit results from Resubmitted Lots are not used by the software to calculate the Entity’s Audit Severity.

Sample

 

Series of Items randomly selected from a Lot for audit

Sample Size

SS

Number of items in a Sample. Defines the exact number of Items* that must be randomly selected from a Lot for the software to assess whether the specified AQLs within defined sampling –risk levels.

 

* For each Compliance Class where the Audit Plan is configured to measure Total Non-compliant Criteria per 100 Items

System Administrator

 

User who has been allocated system administration responsibilities including: adding, configuring, editing and deleting Compliance Plans, creating Audit Requests and adding other users, including System Administrators.

Total Compliant Criteria

TC

Total number of fulfilled Criteria in a Sample.

Total Compliant Items

TCI

Total number of Items in a Sample that have 100% fulfilled their Criteria.

Total Non- Compliant Criteria

TNC

Total number of non-compliant Criteria found in a Sample.

Total Non-compliant Items

TNCI

Total number of Items found in a Sample that have one or more non-compliant Criteria