Will the design plans be documented?

M

meserret

#1
I am working in a newspaper and we newly included our internet site to the scope of our quality system. We accepted that, if any changes are done at our internet site then it requires a design process. The changes sometimes are decided by internet editor only. Sometimes advertisement department takes role in this decision. So, the planning sometimes is very complicated but sometimes it is very very simple as "the page will be completed by tuesday..". So, i want to learn do we have to document our desing plans or is it adequate only to say that it was made.

I hope i could explain the problem sufficiently.

Thanks for your help.

------------------
Meserret
 
Elsmar Forum Sponsor

Marc

Fully vaccinated are you?
Leader
#2
The short answer is if you do not document it it didn't happen.

That said, you shold as a minimum map out the basics. Think of it in terms of purchasing something. If you only want to buy a $10 tool, there is one 'approval' path. You want to buy a $1,300 machine there is probably another approval path. You want to spend $193,000 to upgrade a department there will be another approval path.

Do the same. At what 'level' does another level of management have to approve. But keep it simple. Keep details to a minimum - think scope. Daily update? Breaking news update? Entire site is revamped including structurally? Weekend inclusion?

You should be able to flow chart the base system fairly easily once you get to thinking about who does what and when.

As far as documnenting the changes themselves, yup - but your site editor (Dreamweaver or {god forbid} GoLive or whatever) should allow for notes and such for changes. Document 'minor' changes there.

Use your system documentation to define what is a 'significant' change and what is not - assuming 'significant' changes will have to be documented more thoroughly than 'minor adjustments' or such.

Yes - you have to document your design system and you have to keep records of design changes.

[This message has been edited by Marc Smith (edited 12 February 2001).]
 
M

meserret

#3
Thank you for your answer and please excuse me for my lack of understanding. So, if I map the entire design process and write down it as a work instruction which is telling who is responsible from what and telling all the stages; is it enough as a documentation? We want our internet department to fill in some forms showing the responsibles and stages and they find these forms nonsense. They say, everything they do can be seen on the screen. Who designed the site, which pictures are used and so on. They are asking us to reduce (really: cancel) these forms.Is it a necessity to write down on some sort of forms who will supply the inputs and when; who will verify the desing and when; who will validate the design and when?

Thenk you for your patience and help.

------------------
Meserret
 

Marc

Fully vaccinated are you?
Leader
#4
As I said, you have to define the system - I recommend flow charts.

Yes - they can see it on-screen and such. They may be tracking changes as I said above - the program they are using (for example I use DreamWeaver) may allow them to track changes. But what is part of your process and what is really a design change?

This does not remove the neccessity to define the basic system and to define responsibilities, by the way.

As far as forms being filled out goes, you have to determine at what threshold a form will be required. If they want to change a footer, who is required to authorize it? You say you're a newspaper -- a late breaking story comes in. Who can authorize it to be published on the site? Surely not just anyone. Do you need a form at this level? How is the authorization communicated? Does an editor call the layout person and say something like "...Late breaker to post. File is ready - file name is 1234-detmd-23m-wwet.doc and it's on the Z drive in the 'late_breaker directory. Put it on page 1 under our 'Late Breakers' sub-heading." Or is this communicated by e-mail? Does this need to be documented? It depends upon how you have your system set up. That's part of your process and less of a design issue, in my opinion.

Let's take another example. Let's say the layout person wants to make a major change to the site layout. S/he wants to move the 'Late Breakers' links to another page - taking it off the main page. And s/he wants to eliminate 30% of the advertising space because s/he believes the advertisements are distracting from the content and are thus driving 'customers' away. Who can approve these changes? Do you feel written evidence is necessary? Do you need a form or will a log do? These are just a few questions you have to ask yourself about what you do now.

1. Never require paperwork without a good reason.

2. Make sure you have a well defined line distinguishing what is, in fact, a design change as opposed to part of the process (reporting the news or whatever).

[This message has been edited by Marc Smith (edited 12 February 2001).]
 
Thread starter Similar threads Forum Replies Date
J Incoming Inspection Plans under Design Control (part of DMR)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
J Writing FAA Certification Plans - Compliance of the Design to the applicable FARs Federal Aviation Administration (FAA) Standards and Requirements 3
K Design of Lot Acceptance Sampling Plan - Zero Acceptance Number Sampling Plans Inspection, Prints (Drawings), Testing, Sampling and Related Topics 27
I Quality R&D - How to apply quality principles/plans to a strict design R&D setting? Design and Development of Products and Processes 2
L Design Transfer Concept of cloud SaMD US Medical Device Regulations 1
M IVD Device Design Change Medical Device and FDA Regulations and Standards News 1
S Design and Development document ISO 13485:2016 - Medical Device Quality Management Systems 2
M Risk-based approach to Test Method Validation for Design Verification? US Medical Device Regulations 4
S Is design and development clause 8.3 applicable for laboratory ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
K Design: Verification Vs Validation And Validation Vs Transfer ISO 13485:2016 - Medical Device Quality Management Systems 19
L To control the essential design outputs Medical Device and FDA Regulations and Standards News 4
C MD Design and development procedure ISO 13485:2016 - Medical Device Quality Management Systems 1
B Validation of design for valve api 6d 25 edition ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 0
B Hi , everyone i need a procedure for validation of design prototype api 6d (valve manufacturing) Oil and Gas Industry Standards and Regulations 1
K Exclusion of 8.3 Design and Development for Design Companies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
J Recognised/reputable courses for ISO 13485 Section 7.3 (Design & Development)? ISO 13485:2016 - Medical Device Quality Management Systems 1
J Design/Development. Oil and Gas Industry Standards and Regulations 6
O Regarding design and development requirements for a medical device EU Medical Device Regulations 6
W Rights of Supplier in Design & Build WP Manufacturing and Related Processes 0
K ISO 13485 Design Requirement with respect to "component" manufacturers ISO 13485:2016 - Medical Device Quality Management Systems 11
rob3027 ISO 13485 justification for design and development exclusion for medical packaging ISO 13485:2016 - Medical Device Quality Management Systems 18
K What constitutes design under 9001? Design and Development of Products and Processes 15
P Product Requirements Control during Design Changes Design and Development of Products and Processes 4
B Minitab factorial design regression equation center point term Manufacturing and Related Processes 1
J Design Input Verification 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
P Self Certified Class 1 MDR 2017/745 Design Change CE Marking (Conformité Européene) / CB Scheme 2
N Design V&V courses Career and Occupation Discussions 11
B AS9100 Design Authority questions AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
K Process FMEA responsible For "Make to Design Parts" (Inhouse or Suppliers ?) FMEA and Control Plans 3
K CE design Certificate EU Medical Device Regulations 3
M ISO 13485 consultants and auditors with design oriented focus ISO 13485:2016 - Medical Device Quality Management Systems 7
T Design Transfer & use of "prototype" components in production devices. ISO 13485:2016 - Medical Device Quality Management Systems 10
Q What are Quality Requirements for Design? Quality Management System (QMS) Manuals 8
G Mfr. Process Validation BEFORE Design Transfer? Other Medical Device and Orthopedic Related Topics 1
B Use of Statistical Techniques in Design Verification Design and Development of Products and Processes 18
X Design stage overview (Product specification) EU Medical Device Regulations 3
gohyl Fixture Setup Design Manufacturing and Related Processes 3
D IS0 13485 - Design perspective to regulatory requirement. ISO 13485:2016 - Medical Device Quality Management Systems 3
T Software item classification and Detailed Design IEC 62304 - Medical Device Software Life Cycle Processes 4
armani 7.1.5 and design and development of product ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Sidney Vianna ISO 9001 News ISO 9001 Design Specification to be developed - May 2022 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
C Design output vs acceptance criteria ISO 13485:2016 - Medical Device Quality Management Systems 8
M Design Control Procedure Medical Device and FDA Regulations and Standards News 4
lisap Design falling outside ISO scope Misc. Quality Assurance and Business Systems Related Topics 11
S Link Between Essential Performance Requirements and Essential Design Outputs 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
G Calculating Ppk for Design Verification - Variable Sampling Design and Development of Products and Processes 15
G How many Design FMEAs do you have? FMEA and Control Plans 4
G Updating FMEAs after Design Updates FMEA and Control Plans 4
Stoic Details of Operational Qualification (OQ) test design for plastic extrusion processes, effect of material property noise, and GHTF/SG3/N99-10 US Medical Device Regulations 2
H R&D and Design procedures - can one procedure cover both activities Design and Development of Products and Processes 6

Similar threads

Top Bottom