Requirements for Layered Process Audits including Maintenance, Shipping, Receiving

J

jakhill

Registered
#1
#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?
 
GAGEpack - Gage & Calibration Management
Elsmar Forum Sponsor
antoine.dias

antoine.dias

Quite Involved in Discussions
#2
#2
jakhill said:
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?
Click to expand...
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.
Click to expand...
Interpretations are possible on the wording "all elements" - does this include e.g. maintenance ?
 
Howard Atkins

Howard Atkins

Forum Administrator
Staff member
Admin
#3
#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.
 
You must log in or register to reply here.
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
S IEC 60601-1-11 Requirements related to Storage and Distribution IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
B Software as a Medical Device - Language Requirements EU Medical Device Regulations 4
J Recall requirements for a distributor Medical Device and FDA Regulations and Standards News 1
Q World-wide language requirements Other Medical Device Regulations World-Wide 1
E Marketing, product and system requirements IEC 62304 - Medical Device Software Life Cycle Processes 2
C PPAP requirements for consumer product APQP and PPAP 2
was named killer Calibration Requirements General Measurement Device and Calibration Topics 12
S ISO 14644 Cleanrooms: Industry-Specific Requirements for Medical Devices Other Medical Device Related Standards 0
E IVD devices helping labs meet CLIA/CAP QC requirements? Hospitals, Clinics & other Health Care Providers 0
N The new MDR requirements - SPR section #10.4 EU Medical Device Regulations 2
S In Field Validation Requirements Other Medical Device Related Standards 1
S Clinical trial requirements for UKCA mark in UK UK Medical Device Regulations 4
F Product classification according to the 60601-2-57: Particular requirements [...] of non-laser light sources [...] IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
DuncanGibbons Safe-Life, Fail-Safe and Damage Tolerant approaches and their relevant material property requirements Federal Aviation Administration (FAA) Standards and Requirements 0
B Protective impedance as MOOP/MOPP - Requirements? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
Sidney Vianna IAQG News New IAQG Resources - AS9104-3 Requirements for Aerospace Auditor Competency & Training Courses AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
D IATF Requirements if remote plant has no interface with OEMs who are part of IATF? IATF 16949 - Automotive Quality Systems Standard 6
D Cleanroom requirements for surgical apparel EU Medical Device Regulations 2
M Customer Specific Requirements - Packaging Spec IATF 16949 - Automotive Quality Systems Standard 10
M FDA Syringe Marking requirements US Food and Drug Administration (FDA) 4
R Flammability requirements for applied parts as per 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
B Acquired Medical Device Product Line - Documentation Requirements for Device Master Record ISO 13485:2016 - Medical Device Quality Management Systems 7
D Customer requirements on specific standards Various Other Specifications, Standards, and related Requirements 6
S State Licensing requirements for Medical Devices sold in the US directly to hospitals and tissue banks 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
R PPAP Requirements for Tool Repair or Refurbishment APQP and PPAP 5
I France clinical trial requirements EU Medical Device Regulations 1
J Outsourced Internal Audit requirements for Aerospace Suppliers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 21
H Electronic care product on patient bed side - Flammability requirements (62368-1) Hospitals, Clinics & other Health Care Providers 0
D Digital Healthcare - QMS requirements Other US Medical Device Regulations 3
M GP-12 procedure form and requirements Customer and Company Specific Requirements 1
G How to implement H&S and Quality Control Requirements in Contract for Potential Supplier? Contract Review Process 6
D Customer Specific Requirements / Customer Requirements for Indirect Customers IATF 16949 - Automotive Quality Systems Standard 10
J Print Requirements Manufacturing and Related Processes 9
S Requirements for Certificate of Destruction for Surgical Instruments Medical Device and FDA Regulations and Standards News 2
R FAI & P.O. Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 21
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 5
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

Similar threads

Top Bottom