You Got To Have Plan
Starting any type of business project or initiative without some level of planning would be foolish. This is reinforced in the ISO standard through clause 8.3.2 which defines requirements for an ISO 9001 design and development plan. At this point, we’ll assume that you have already assessed the viability of the project and determined an acceptable return on investment.
An excellent place to start with project planning would be to define the vision, goals, objectives, scope, expected results, and anticipated outcome for the project. Without a plan, there is no way to know when the project will be complete, how much it will cost, what resources are needed, and when they will be required. It would also be good to define how resources will interface, communicate, and engage during the project. Not all resources are internal, so don’t forget to establish plans and schedules for external resources such as materials, equipment, contractors, consultants, and other service providers.
You can usually count on things going wrong during a design and development project, so be sure to assess project risk and building in buffers to account for and mitigate these risks.
Beyond ISO 9001 design and development plan requirements, let’s use some of our time today to explore the ISO 9001 design and development change clause and also discuss a topic that ISO 9001 doesn’t really touch on, Project Management.
Design & Development Plan
Planning is an important fundamental discipline scattered throughout the entire ISO 9001 standard. In fact, Section 6 of the standard is titled “Planning” and sections 8 and 9 include several other planning requirements. Planning is also the first sub-clause within the design and development section, and it should be the first major designed and development task completed.
ISO requires organizations to consider the requirements and logistics for the project and to establish some form of design and development plan (D&D plan). The level of detail and complexity within the plan should be commensurate to that of the project and products or services to be designed and developed. ISO states that the following elements should be defined, as applicable:
- Different stages, milestones, phases, etc. to be completed or executed during the project,
- The milestone, project, and design reviews to be completed throughout the initiative,
- The design verification and validation activities to be completed (include both product and process verification and validation where applicable),
- The responsibilities and authorities required to complete the project,
- The internal and external resources needed for the project (personnel, external providers, equipment, materials, knowledge, facilities, etc.),
- Interface and communication requirements and methods between personnel, external providers, functions, customers, and other key stakeholders (interested parties),
- How and when product or service customers or users will need to be involved throughout the project,
- How the product or service will be produced and delivered to the customer (production / delivery processes),
- Where relevant, the amount of control expected by customers or other parties, usually associated with contract design and development services,
- Documented information required during the project (what procedures and other documents govern and are required to execute the project).
Your planning process and documentation should provide an easy method to track project performance and demonstrate that tasks and deliverables are complete. A basic Gantt chart can go a long way towards satisfying the ISO 9001 requirements and provides an easy method to display and track progress during the project. If your organization executes numerous or complex projects, you might consider employing personnel with formal project management knowledge and competencies. While Microsoft Project is the preeminent project management and scheduling application on the market, it is one of the more expensive and complex products. There are numerous other project management applications on the market which are much cheaper and easier to use. In fact the EBS ISO 9001 eCoach system provides a simple template and ISO 9001 development schedule example using a simple MS Excel spreadsheet. Do your homework and pick an application and tool that best fits your company and project needs.
Your plan should be a living document throughout the entire ISO 9001 design and development initiative. This means that you don’t just create a plan at the beginning of the project and consider the planning effort complete. The plan should be revised, updated, reviewed, and controlled during the entire project timeline.
Design and development change activities should be considered as part of your organization’s overall change management process. ISO 9001 defines requirements for managing changes throughout the entire standard, and this is just one more change management clause specifically focused on changes to product, service, or process designs.
Let’s assume that you’ve already developed an overarching change management process which defines actions to identify, assess, review, and execute changes throughout the organization. This change assessment should, when warranted, indicate a need to make changes to product design. When a design change is needed, a new design and development project should be initiated, and the project should follow your established design and development processes.
Whether the effort is a simple or minor change to a design feature or packaging or a significant rework of the entire product design, remember that one small change can ripple through and drive changes to many of the other design and development documents. Changing one aspect of the design output might require changes to the design input requirements, necessitate one or more design reviews, force revisions to specifications and technical documents, and require some level of re-verification or re-validation activities. Also, don’t overlook the impact and effect the changes might have on production processes, external providers and the items they provide, verification and release activities, and process validations. We can’t stress enough the need to be diligent when making such changes as small oversights can become major issues with the product at a later time.
Note that some organizations establish formal Engineering Change Notice (ECN) or Engineering Change Order (ECO) processes to manage, evaluate, and document product design changes. This is a popular approach and is entirely acceptable. If this is your established method and you desire to use this approach, then, by all means, go for it. A Google search will provide a significant amount of information and examples of these different change management methodologies.
We have created a decision tree diagram to help determine what aspects of the product design and associated documentation that need to change or be revised in a given situation. You can get access to this free tool and other valuable documents here. Your existing project file for the initial design and or previous changes should include all the required design and development records, files, and other artifacts which can provide a baseline for starting a new design change file. Any new project initiated to change a current design should be appended to or reference the original development project file. It is important to establish and maintain traceability to all design and development files throughout the entire product lifecycle.
ISO 9001 doesn’t reference or stipulate requirements for formal project management activities within the standard; however, given the project-oriented nature of design and development activities, it would be prudent to consider and implement some form of project management methodology. One of the better-known methods is the traditional basic “waterfall” or “phase-gate” project method utilized heavily throughout many different companies and industries.
It is recommended that you do some research and find an approach and method that is appropriate for your company and the type of projects executed. As applicable, you might consider retaining a project management resource or training internal personnel through some of the different project management organizations such as the Project Management Institute (PMI). Another option would be to retain one of the numerous project management consultants to help guide your organization in the development of a proper methodology and to train personnel as needed. Again, do your homework and diligence to ensure the right consultant is retained.
Starting a project without a plan and defined methods would be unwise. The standard define fundamental ISO 9001 design and development plan and change management activities and deliverables that should be considered for any type of project. Remember that your project methods and activities should be appropriate for the complexity and scope of the project and associated products or services to be developed. Once planning is complete and you have defined your project management methodology, it’s time to established the design inputs and requirements specifications for the project. We will look ISO 9001 design inputs during our next article installment.