Requirements for Layered Process Audits including Maintenance, Shipping, Receiving

#1
Hello,

I had previously worked for a company that included all departments for our LPAs. I am now with a company that only completes LPA for the manufacturing floor process. I am curious as to if anyone knows if there is a standard requirement?
 

antoine.dias

Quite Involved in Discussions
#2
Hello,

I had previously worked for a company that included all departments for our LPAs. I am now with a company that only completes LPA for the manufacturing floor process. I am curious as to if anyone knows if there is a standard requirement?
In the standard itself there is no mentioning of LPA.
In some of the customer specifics there is.
Example for Fiat-Chrysler :
Organizations supplying production parts or components to FCA US shall conduct Layered Process Audits (LPA) on all elements of manufacturing and assembly lines that produce production parts or components for FCA US.
Interpretations are possible on the wording "all elements" - does this include e.g. maintenance ?
 

Howard Atkins

Forum Administrator
Staff member
Admin
#3
GM states

4. All departments within the organization.

They also state

In addition to layered process audits the organization shall audit specific manufacturing processes
(see chart below) annually to determine their effectiveness. Applicability and effectiveness of these
processes shall be determined utilizing the most current version CQI standard (see chart below). The
effectiveness evaluation shall include the organization’s self-assessment, actions taken, and that
records are maintained.


This might be the difference but as antoine stated the requirements for LPAs is a customer one only

Look at what your customers want and what you want to achieve.
Too often the LPAs are a total waste of time and are no more than pencil whipping.
 
Thread starter Similar threads Forum Replies Date
Douglas E. Purdy Delphi CSR (Customer Specific Requirements) and LPAs (Layered Process Audit) IATF 16949 - Automotive Quality Systems Standard 3
R GM Layered Process Audit - Seeking the actual General Motors requirements Process Audits and Layered Process Audits 36
R FAI & P.O. Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
W MDD Distributor Registration Requirements Other Medical Device Regulations World-Wide 0
M FDA Requirements for Investigational Devices - Clinical Investigation & Shipping Medical Device and FDA Regulations and Standards News 0
B Requirements for LiPo Batteries in the EU ? CE Marking (Conformité Européene) / CB Scheme 7
pbojsen ISO 13485 Requirements versus FDA product classification and GMP exemptions - Audits ISO 13485:2016 - Medical Device Quality Management Systems 3
A MDR - Legacy Device Review Timeframe and Requirements EU Medical Device Regulations 3
J Translation requirements for the statement referred to in ANNEX XIII of MDR EU Medical Device Regulations 0
D Hand Held medical device - power supply requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
J Gauge Management - with ambiguous requirements & no support ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
lanley liao How to understand and master the requirements of each section in API monogram product. Oil and Gas Industry Standards and Regulations 5
K ASME, ANSI, ASTM and similar specifications and their requirements for document control. Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
Y MDR requirements for Class I accessories EU Medical Device Regulations 2
K IATF audit day requirements table 5.2 IATF 16949 - Automotive Quality Systems Standard 6
L Change Notification Requirements for class 1 devices Medical Device and FDA Regulations and Standards News 1
C Requirements for distributors under MDR: translation EU Medical Device Regulations 0
D What are the acceptance criteria/requirements for Stability Study? General Measurement Device and Calibration Topics 7
P UDI-PI requirements on reusable surgical device, do we need serialisation? ISO 13485:2016 - Medical Device Quality Management Systems 3
Sidney Vianna Interesting Discussion Should ISO 9004 be changed from a guidance document to a requirements standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
J WAIVED ON Q1 - We Don't have to comply with FORDS customer specific requirements IATF 16949 - Automotive Quality Systems Standard 3
Q Do these certificates of calibration meet ISO 9001 requirements for traceability to NIST? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
Techilady Ford Special Characteristics Communication and Agreement Form (SCCAF) provides production requirements? FMEA and Control Plans 4
P Requirements for being an European Representative EU Medical Device Regulations 3
C ISO 14001:2015 6.1.3 Compliance Obligations - Legal requirements monitoring ISO 14001:2015 Specific Discussions 0
A GPS Regulatory requirements? Manufacturing and Related Processes 6
J SSQR-01 Vision Requirements- Color Blindness AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
P ISO 14644 Class 8 Cleanroom Air Filter Requirements Other Medical Device Related Standards 4
J Requirements as a Distributor for Incoming Inspection of Purchased Finished Medical Device Medical Device Related Regulations 0
R Weld Penetration Standards and Requirements Manufacturing and Related Processes 2
S Registration of Medical Device in Hong Kong - labeling requirements Other Medical Device Regulations World-Wide 1
L Requirements for Cables used for Low-Voltage DC Mains (12-36VDC) IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M AS9100D Registrar pre-audit requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 15
S Determining the requirements for the products and services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
D LiPo battery minimum requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
V MDSAP Requirements for Device Designer Canada Medical Device Regulations 1
J Biocompatbility testing on Class 1 device requirements Other US Medical Device Regulations 12
Le Chiffre Online training available for ISO/IEC 17021-1: Requirements for bodies providing audit and certification of management systems Training - Internal, External, Online and Distance Learning 3
S What are the International Forging Requirements for Nitrogen Strengthened Stainless Steel? EU Medical Device Regulations 3
M Supplier requirements - Major supplier is a Non-Profit registered with ICCBBA (FDA UDI) Supply Chain Security Management Systems 12
R Components to a finished medical device, MDR requirements Other US Medical Device Regulations 1
S Distributor requirements in US 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
K AS9100D 8.2.1 Review Requirements for Products and Services AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
F Environmental Requirements E-Lab General Measurement Device and Calibration Topics 0
T 21 CFR 820.20 - Quality Planning Requirements? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
N Composites - Freezer sensor requirements Manufacturing and Related Processes 2
A Requirements for Contract Manufacturers Other Medical Device and Orthopedic Related Topics 3
O Informational Ford Motor Company Customer Specific Requirements for IATF 16949:2016 - 08 Jan 2021 Customer and Company Specific Requirements 0
M IEC 61010-1 requirements for motors Other Medical Device Related Standards 0

Similar threads

Top Bottom