Basic format for Design and Development

L

lgoeke

#1
I was wondering if anyone had a very basic manufacturing format for Design and Development. I am currently revising our process and I am struggling with the definitions of the terms and who should be responsible for each (inputs, outputs, etc.). I have read other posts but didn't really find the answer I was looking for. I would appreciate any help.
 
Elsmar Forum Sponsor

Randy

Super Moderator
#2
The basic format is defined in Section 7.3 Design and Development from 7.3.1 to 7.3.7

Everything necessary for D&D is performed within those requirements.

You're going to get a lot of answers but they are all going to boil down to meeting the requirements as provided.

The defining of responsibilities is up to you to suit your needs, use whatever job titles you want, there isn't any right or wrong. It's you system, use what you want and don't dwell on what others do or try to make others happy.

Quality system related terms are clearly defined in ISO 9000:2005


Where you at in Arkansas?
 
L

lgoeke

#3
The problem I am having is deciding which process to list for each requirement. We have processes that could be inputs or outputs. And I was also not sure if we should be the ones to validate or should our customers?

Flippin actually. Home of Ranger Boats as most people know it.
 

Randy

Super Moderator
#5
You gotta understand that an output of one thing may very well be the input into another. What has to be done is the management of the linkage between them. You are not suffering under something unique.

You entire organization is nothing more than a single large process transforming inputs into outputs and containing multiple smaller processes doing exactly the same thing. Each "process" may have one or more inputs that must be converted into one or more outputs which may or may not need to be fed into another "process".

To easily understand what I am talking about just get a box of Jello (preferably cherry), look at the picture on the front...that is the desired output. Turn the box over and read the instructions. You will see the necessary inputs, the "product realization process", the monitoring and measuring requirements and the desired end result and hopefully customer satisfaction is the result.

What you guys do is not different than making that Jello, it's just a bit bigger with a few more extras.
 
Thread starter Similar threads Forum Replies Date
N Help with basic understanding of Competence requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A GMDN Registration Basic preliminary Information EU Medical Device Regulations 0
M Basic UDI and technical documentation EU Medical Device Regulations 1
C NB approval - Basic question about Notified Bodies and their role EU Medical Device Regulations 10
B Seven Basic Quality Tools (January 23) [Paid] Training - Internal, External, Online and Distance Learning 1
E Three basic questions about ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
rezayatmand IEC 60601-2-18 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipmen IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
B Evaluation of Basic Safety during EMC Immunity or Climate Testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
A What is the difference between Basic UDI-DI and UDI-DI? EU Medical Device Regulations 6
J How to measure a Critical Characteristic that is a Basic Dimension Misc. Quality Assurance and Business Systems Related Topics 6
M EU Basic UDI-DI Trigger Points - When is a new Basic UDI-DI required EU Medical Device Regulations 3
M Informational EU – MDCG 2018-1 v2 Guidance on basic UDI-DI and changes to UDI-DI Medical Device and FDA Regulations and Standards News 0
F MDR 2017/745 Basic UDI-DI, UDI-DI & UDI-PI EU Medical Device Regulations 0
L Unacceptable risk for basic safety prior to or after mitigation? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
N EU MDR Basic UDI-DI and Technical Documentation for Systems EU Medical Device Regulations 22
E Basic Risk based thinking questions Risk Management Principles and Generic Guidelines 5
S Question about a basic additive variance/tolerance example Quality Tools, Improvement and Analysis 2
M Medical Device News EU – MDCG 2019-1 MDCG guiding principles for issuing entities rules on Basic UDI-DI Medical Device and FDA Regulations and Standards News 0
Marc Basic - How to Start a New Discussion Thread Elsmar Xenforo Forum Software Instructions and Help 1
S Basic Dimension W/O using FCF Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
V Carbon Black (Master Batch) - Basic Requirements Manufacturing and Related Processes 5
G Setting Up a Basic Quality Lab for a small manufacturing company General Measurement Device and Calibration Topics 2
P Basic Minitab Help - It's about Linear Regression Using Minitab Software 1
L Lean Book for Basic Knowledge Lean in Manufacturing and Service Industries 2
L Seeking help in Basic Maintenance Knowledge Manufacturing and Related Processes 4
M "Basic Safety" versus "Essential Performance" IEC 60601 - Medical Electrical Equipment Safety Standards Series 12
M Use of Excel and VBA (visual basic for applications) in quality systems Excel .xls Spreadsheet Templates and Tools 3
P Basic questions about earning TSOA (Technical Standard Order Authorization) and PMA Federal Aviation Administration (FAA) Standards and Requirements 2
J Excel spreadsheet to use Basic and Mini MOST for Line Balancing Document Control Systems, Procedures, Forms and Templates 1
T How to report Basic Dimensions on a Dimensional Report (ISIR) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
A Basic ISO 13485 Training Material ISO 13485:2016 - Medical Device Quality Management Systems 5
M Basic Dimensions on Machining Prints Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
M Basic International Standards required for a Manufacturing Industry (Optical Media) Other ISO and International Standards and European Regulations 4
L How to set up a basic electronic test equipment calibration laboratory General Measurement Device and Calibration Topics 3
R Rejecting a Part when Dimension Feature is Basic Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
O Metrology Devices to Measure the Basic Dimensions of Plastic Specimens General Measurement Device and Calibration Topics 6
F ISO 9001:2008 Fundamentals: Basic Questions - Controlled Documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
E How can I measure three true positions? GD&T basic question General Measurement Device and Calibration Topics 5
M SPC, Moving Range Chart and Weighted Graph Basic Questions Statistical Analysis Tools, Techniques and SPC 1
T Basic Document Control Database (Excel/Access) Document Control Systems, Procedures, Forms and Templates 3
V The Purpose of Basic Dimensions on Prints APQP and PPAP 6
N Basic requirements and steps involved to get NADCAP Certification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
D Profile of a Line of a radius of 25mm basic dimension - Question Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
C Basic Internal Calibration Procedure to check the Accuracy of a Balance Calibration Frequency (Interval) 6
P Basic Food Hygiene Presentation Training - Internal, External, Online and Distance Learning 6
M Training Toolbox for Basic Food Hygiene - Food Safety Food Safety - ISO 22000, HACCP (21 CFR 120) 2
Q Basic questions about AS9100C Quality Standard Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
D Basic Educational Film - What Quality is all about ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Basic Internal Auditor Training Powerpoint File Internal Auditing 26
S Basic Environmental Aspects Register template wanted Document Control Systems, Procedures, Forms and Templates 1

Similar threads

Top Bottom