Manufacturing Terms
AML(Approved manufacturer list) -This is a list of manufacturers selected based on their qualifications and approved in advance of their potential use.
AVL (Approved vendor list) -This is a list of vendors and also suppliers in the manufacturing process that are approved in advance based on their qualifications, typically for a specific process.
BOM (Bill of materials) -This it the list of parts required to produce a finished assembly, typically appearing on the assembly blueprint.
BOM Level (Bill of materials level) -This means the parts and material identified for use on a bill of materials and where these parts, assemblies, and components fall in the hierarchy of the BOM.
CAPA (Corrective action/protective action) -A plan to rectify in process mistakes or to prevent them from occurring.
Change Management –The act of instituting formal engineering, process, or management changes with a thought to anticipating unintended consequence while creating a positive outcome.
Child Item – In the BOM this is an item that is the child to the main parent item.
Compliance -The act of conforming to an established standard, typically a rule or legal standard.
DHF (Design history file) -Refers to the collection of documents related to the design history recorded from inception to production and change of a device. Most typically related to the Medical field. See 21 CFR Part 820.30
DMR (device master record) -Everything you need to build and test the device is recorded and or the location of said records are listed. Specifications and the procedures would be recorded here for the finished product. See CFR 21 Part 820.40
DHR (Device History Record) -This is the record of all the actual actions taken to produce a device including how many and when they were made.
EBOM (Engineering bill of materials) -A list of processes required to produce a part. This is only for the product that has been engineered itself.
ECR (Engineering change request) -When a part must be changed due to input from use or application a formal document must list the exact actions or changes and must be submitted to the engineer or team responsible for the parts function.
ERP (Enterprise resource planning) -Inventory Control. The optimization of procuring goods for re-sale or manufacture.
FFF (Form, fit & function) -Three key engineering considerations when designing a new part.Typically proved out by using a prototype before production. Form refers to its visual parameters such as the size, shape, and dimensions. Fit refers to how it interconnects with another item. Function is the actions it is designed for.
GMP (Good manufacturing practice) -Accepted and proven Manufacturing process arrived at by practical experience. Not to be confused with (CGMP) Current Good manufacturing practice outlined in Title 21 CFR part 820 Item Master-In Manufacturing there are a lot of parts and processes to keep track of. The item master is a list of every component that the manufacturer buys to build and assemble the products.
ISO 9000 (International standards organization 9000) First international standard dedicated to documenting and practicing a common quality standard.
ISO 13485 (International standards organization 13485) -Quality standard dedicated to medical devices.
ISO 14000 (International standards organization 14000) -Quality standard for environmental considerations.
ITAR (International traffic in arms regulations) -American regulation intended to control access to defense critical manufactured goods from foreign parties.
Made-to-Spec -The act of making a manufactured good to the exact specification of the customer.
MCO (Manufacturing change order) -Once an engineering change is approved, a change order is documented and given to the manufacturing team to put in effect. Mainly for changes in the manufacturing process or approved manufacturing list.
Multi-level BOM -This refers to a list of contents that follows the assembly through multiple processes, listing requirements and included parts for each level.
OEM (Original equipment manufacturer) -The producer of a finished product unique to them or branded as such.
Parent Item –An item that contains a child item in the BOM. The parent the the hierarchy list of items.
Procurement Type -Typically refers to the method and type of purchasing activity as defined by the end user. It can define both the way Contracts for goods are solicited and fulfilled, as well the timing and nature of the delivery of goods.
Prototype -A prototype is made to determine compliance to the intended fit form and function of a part. This part may not be made by the final production process and is often better, which creates problems in customer expectation.
Reference Designator –Used on a blueprint, this is a note or symbol identifying a key characteristic or important feature of the part.
Requirement -A written outline of the terms under which a part or product is to be manufactured and delivered. Typically generated as part of the quote solicitation process and details any government regulations required.
RoHS –ROHS stands for "Restriction of hazardous substances". Originating in Europe, this standard listed 6 chemicals/substances that were prohibited for use. Updated in 2015 there are now 10 Restricted chemicals/substances. They are: Lead / mercury / cadmium / hexvalent chrome / PBB / PBDE / DEHP / BBP / DBP / DIPB
SCAR (Supplier corrective action request) -When defective parts are discovered by an end user the supplier is required to document how said defect will be prevented in the future.
Scrubbing -Confirming that the BOM has all the accurate information and that everything on the BOM has been documented.
Title 21 CFR Part 11 –A Government regulation from the food and drug administration pertaining to the keeping and maintaining of electronic records. FDA website.
Title 21 CFR Part 820 –A Government regulation stipulating current food manufacturing practice applying to all devices for human use. FDA website.
UOM (Unit of measure) -Parts are measured by several standard methods. Thickness can be indicated in metric, inches, and gage. The unit of measurement is indicated in the blueprint title block.
WEEE Directive –A European law dictating the method by which waste electrical and electronic equipment is disposed of.
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