QUALITY MANAGEMENT SYSTEM ISO 9001:2015 CLAUSE 8.3 DESIGN AND DEVELOPMENT
INTRODUCTION TO DESIGN AND DEVELOPMENT
By now, in the design and implementation of your Quality Management System, you should know what you are doing.
Deming said, “Innovation come from the producer, not the customer.” Design & development is an expression of intelligence and is in your hands
“If you can’t describe what you’re doing as a process, you don’t know what you’re doing” – W Edwards Deming
CLAUSE 8.3.1 GENERAL REQUIREMENTS
Firstly, organise a meeting with your employees and examine the processes for the design and development of your products and services. View the stages together with the controls during and after the stages. Examine the controls that manage the processes, for example, decision points, approvals, sign-offs, monitoring, meetings, customer reviews etc.
CLAUSE 8.3.2 PLANNING
Now, decide the control points. The clause asks you to study a list of ten points:
- The complexity of the design
- The process stages, including the review stages
- The testing you will do to check the design
- Who will be responsible, and what authority will they have
- What resources are needed
- The interfaces between teams in the process
- How will customers get involved
- Who will use the design next
- What control do customers and other parties have over the design
- Determine what records you will keep proving what you have done
At Safety Risk Management, we have a variety of processes for design and development with many stages that include activities like:
- Product design and development process
- Training material design and development process
To help our employees to understand the Design and Development process, we take time to analyse and explain the process. Deming said, “it is not enough to do your best; you must know what to do, then you do your best.”
CLAUSE 8.3.3 INPUTS
Then, what are the requirements for what you are designing? You can use the following list as a reference:
- The functional and performance requirements for the design
- Any information from previous designs
- What are the statutory, regulatory, standards or codes of practice requirements
- List any potential consequences of failure
- Make sure the conditions are clearly defined and any conflicts resolved
- Again, determine what records you will keep proving what you have done
CLAUSE 8.3.4 CONTROLS
Ensure you have processes that control design and development, including reviews, verification, validation, problem-solving, and capturing records.
CLAUSE 8.3.5 OUTPUTS
After producing your design, including drawings, specifications, coding, plans, models etc., you must ensure they include the following:
- Firstly, the design meets the requirements
- Secondly, manufacture the design or the service offered
- Thirdly, inspect and test the design
- Lastly, those characteristics of the invention are specified
CLAUSE 8.3.6 CHANGES
At this stage, a Quality Manager may assume that they have done all the hard work; however, they have not put in the time or effort regarding the review sections. Big mistake, huge! There is also the chance of unintentional results because if you leave out this stage or brush over the top of it, the outcome can be costly regarding overlooked prospects and mistakes. All people have a certain amount of tunnel vision, “the big problems are where people don’t realise they have one in the first place.” – Deming. Don’t rush; carefully examine, approve and inspect all the revisions of the design. You don’t want to create other problems. Ensure that you don’t have tunnel vision.
SUMMARY
- Decide processes used determine designing and development of the products and services
- In preparation, take into account the ten points from ISO 9001 when deciding your processes
- What are the needs for your design
- Do the processes influence design and development
- Manage amendments to design and development
- Put valuable revisions in place so that nothing slips through the cracks
SRM is ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018 certified. Contact our consultants today. Let us know if we can help you with the development and implementation of your Quality Management System.
USE SHEQ SOFTWARE
At SRM, we use Mango to review the processes, determine control points and design requirements, and create strategies to control design and development, ensuring that you don’t create expensive problems. In addition, Mango makes it so simple as opposed to using a hard copy system. Not only does SRM use Mango Compliance Software, but many of our clients as well – www.mangolive.com Mango makes it easier to get ISO 9001:2015 certification.
Associated Blogs
https://srmc.co.za/iso-90012015-is-all-about-managing-relationships/
Links to our services:
https://srmc.co.za/services/consulting/
