Steps to Complete Quality Control Plans and Work Instruction

D

dbproject

#1
Hi,

this my first inquiry here in this great an beneficial fourm

1- I need to know the steps to create procedures (or control plans) / work instructions specify requirements for operation, inspection, testing, gauging, production and start-up approval as well as product, process and tooling changes, with recorded results
2- what's the process controls? and what's it for?and what's the difference between control plan & process control?

3- will I make a FEMA for products failure only or for processes, equipment and labor as well?

I really appreciate your help

thank you very much
 
Elsmar Forum Sponsor

harry

Trusted Information Resource
#2
.................. 1- I need to know the steps to create procedures (or control plans) / work instructions specify requirements for operation, inspection, testing, gauging, production and start-up approval as well as product, process and tooling changes, with recorded results
2- what's the process controls? and what's it for?and what's the difference between control plan & process control?

3- will I make a FEMA for products failure only or for processes, equipment and labor as well? ................
Welcome to the Cove.

Is there any particular standard (ISO or others) that you need to comply?

................... 3- will I make a FEMA for products failure only or for processes, equipment and labor as well? ..............
I suppose you are referring to FMEA - are you in automotive?
 
Last edited:
D

dbproject

#3
Hi,

Thank you harry for your reply
ISO 9001 is the standard that I need to follow, I need your help with the points in my first post
I am in feeding industries that produce injectors , bolts and many others and yes, I mean FMEA it was a typo

I really appreciate your help
 

harry

Trusted Information Resource
#4
Refer to ISO 10005: Quality management systems -- Guidelines for quality plans

ISO 10005:2005 provides guidelines for the development, review, acceptance, application and revision of quality plans. It is applicable whether or not the organization has a management system in conformity with ISO 9001.

ISO 10005:2005 is applicable to quality plans for a process, product, project or contract, any product category (hardware, software, processed materials and services) and any industry. It is focused primarily on product realization and is not a guide to organizational quality management system planning.

ISO 10005:2005 is a guidance document and is not intended to be used for certification or registration purposes.
 

smryan

Perspective.
#5
dbproject,
ISO9001 gives you certain things that are necessary to have (work instructions etc.) but there is no specific form or format that is required for most of it. 10 different companies can have 10 completely different ways of meeting the ISO requirements. The key is figuring out what style or format will work best for your company. Or what you already have in place that already meets some of the ISO requirements.

If you are talking about FMEA then you are going above and beyond ISO 9001 requirements. Perhaps you have an automotive customer who wants a PPAP submitted? Then there are some specific forms - that customer should let you know specifically which ones they will require.

In general - as we have applied it - FMEA are done on a product. First the Design FMEA - trying to error proof the product itself in its design phase. Then the Production FMEA - error proofing all steps in the production of the product.
 
Thread starter Similar threads Forum Replies Date
S Calibration conducted to 3 steps only of the std instead of complete 5 steps General Measurement Device and Calibration Topics 4
Z Steps to take before an MDSAP audit for Canada Canada Medical Device Regulations 2
S Sequence of ISO 9001:2015 Implementation Steps ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
N What are the software audit and control steps Reliability Analysis - Predictions, Testing and Standards 2
Anonymous16-2 21 CFR Part 11 - Steps to take if we want to validate an electronic system Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
N MDR review process by notified body - How many steps exist in the review process EU Medical Device Regulations 0
G Start and main steps of API Q1 Certification Process Various Other Specifications, Standards, and related Requirements 5
M FDA News Statement from USFDA on steps to strengthen the long-term safety oversight of the Essure device Medical Device and FDA Regulations and Standards News 0
J Steps when changing material for class 1 medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
N Process Flow diagram steps for inspection and packaging APQP and PPAP 4
leftoverture Control Plan - Multiple Process Steps FMEA and Control Plans 8
M FDA News FDA Report - FDA Has Taken Steps to Strengthen The 510(k) Program Other US Medical Device Regulations 0
M Medical Device News FDA - Transformative new steps to modernize FDA’s 510(k) program to advance the review of the safety and effectiveness of medical devices Other US Medical Device Regulations 0
C Sequence of Process Steps not Respected FMEA and Control Plans 3
Jane's What steps do you take to terminate a product which was licensed for sale in Canada Canada Medical Device Regulations 14
S Technical Steps to ISO 17025 Accreditation ISO 17025 related Discussions 1
G What are steps to be followed to get ISO 9001:2015 certified ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
K IEC 62304 - Compliance steps IEC 62304 - Medical Device Software Life Cycle Processes 5
Q Steps from ISO 9001 2008 to 2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
rob73 New MDD (European Medical Device Regulations) next steps - 2016 EU Medical Device Regulations 1
M ISO 22000 7.3.5.2 Description of Process Steps and Control Measures Food Safety - ISO 22000, HACCP (21 CFR 120) 1
C Quality Assurance Manager ? Next Steps? Quality Manager and Management Related Issues 10
D Key steps to OHSAS 18001 Implementation Other ISO and International Standards and European Regulations 1
V Analysis of 'Value Added' System & Process Steps - Inspection Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
S What are the next steps after providing response to FDA 483 ? US Food and Drug Administration (FDA) 7
R Steps to Preserve ISO 9001 Certification during Corporate Acquisition? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Q Moving steps from ISO 9001 to TL 9000 TL 9000 Telecommunications Standard and QuEST 4
C Must we identify steps taken to identify the Root Cause of a failure Nonconformance and Corrective Action 15
Sam Lazzara 12 Steps to FDA UDI (Unique Device Identification) Compliance (2013 - 2015) Other US Medical Device Regulations 45
G Further steps in Medical Devices Regulations in EU - Comments? EU Medical Device Regulations 11
J Eliminating Missing Steps In Manual Operations Human Factors and Ergonomics in Engineering 8
N Basic requirements and steps involved to get NADCAP Certification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
S Change in Career Path - Logical Steps Up and Ways Forward Career and Occupation Discussions 3
M The steps that my ISMS Internal Audit Report has to Contain IEC 27001 - Information Security Management Systems (ISMS) 3
S Depicting Communication Flow Gaps between Departments/Process Steps on a Process Map Process Maps, Process Mapping and Turtle Diagrams 1
J What are the steps to transfer TS 16949 certification or switch registrars? Registrars and Notified Bodies 4
B How many steps does a procedure have? Document Control Systems, Procedures, Forms and Templates 9
A PFMEA for an Assembly Process - Stuck in first steps FMEA and Control Plans 6
M System Building - What are the key steps? Quality Manager and Management Related Issues 2
H Process Development to Validation: What are the steps? Design and Development of Products and Processes 3
V What are the Steps in Ensuring a Definition/Implementation of an Effective Procedure Document Control Systems, Procedures, Forms and Templates 3
T Pilot's Checklist for Six Sigma - Steps to Consider when Initiating Projects Six Sigma 3
R Sales Order Process Flow Plan (Flow Chart) Steps help ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
K Seeking guidance on Preliminary Steps to enable Hazard Analysis Food Safety - ISO 22000, HACCP (21 CFR 120) 1
bobdoering The CORRECT steps to implement an SPC chart Imported Legacy Blogs 16
E What are the general steps to distribute a medical device in U.S.? US Food and Drug Administration (FDA) 1
M How to Implement the QHSE Integrated Management System Easy Steps? Occupational Health & Safety Management Standards 1
A One of APQP Process Steps - OTS (Off Tool Sample) Approval APQP and PPAP 1
L Importing CSV (comma separated values) / Excel process steps into Visio diagram Excel .xls Spreadsheet Templates and Tools 2
B Green Initiative - Please help me in preparing Go Green Steps.... Sustainability, Green Initiatives and Ecology 6

Similar threads

Top Bottom