Overview of ISO 9001 Design and Development
Not all companies need to define and implement processes that satisfy the ISO 9001 design and development requirements. Organizations that merely manufacture products or deliver services don’t need to worry about this section of the standard. Also, companies such as machine shops, assembly houses, or contract manufacturers that execute a work package to customer specifications are off the hook for these requirements. If you aren’t sure where you land, consult with a knowledgeable resource and verify your decision with your ISO 9001 registrar (certification body) and auditor.
If your organization provides design and development services or develops proprietary products or services, then the ISO 9001 Design and Development requirements (clause 8.3) probably do apply. If your company doesn’t do any design and development activities, these next few articles aren’t applicable, and you can claim an exemption from this section of the ISO 9001 standard.
ISO 9001 states that your design and development (D&D) process must be controlled and defines some specific controls in clause 8.3.4 (Design & Development Controls), including the need for design review (8.3.4b), design verification (8.3.4c), design validation (8.3.4d), and actions for reviews (8.3.4e). We’ll explore these in greater detail throughout this and future articles. You must also plan your design and development projects, define the design inputs and design outputs, control any design changes, and retain appropriate documented information.
There is much to cover concerning ISO 9001 Design and Development, so I plan to create a mini-series of articles over the next couple of months just focused on design and development. Sub-topics include:
- D&D Planning
- D&D Inputs
- D&D Outputs / Transfer
- Design Verification & Validation
- Design Reviews
In this initial article, we provide an introduction to design and development, define some key terms, and cover some ancillary deliverables and activities to be addressed. This will help establish a baseline for future articles on this topic. For the remainder of this and future ISO 9001 design and development articles you can refer to the following basic block diagram:
Definition of Expected Results (Clause 8.3.4a)
Clause 8.3.4 states that you need to ensure that the anticipated results for the design & development project or initiative are defined. It certainly would be foolish to start a design and development initiative without clearly defining the goals and scope of the project. If you have defined your goals and objectives in the D&D plan or D&D inputs you have satisfied this requirement and there is no further work to be done.
- Design & Development Plan: Your D&D Plan should establish and document the main high-level objectives of the project along with the desired results to be obtained. This provides the development team and the organization with a vision for the project and helps to guide the team when defining the detailed planning requirements. Information might include a description of the product or service to be developed, the intended use for the product or service, the target customer or market, general financial goals and constraints, high-level performance objectives, sales forecasts, target launch dates, etc. These goals and objectives to be realized should be written at an executive level and should be agreed to by appropriate management personnel. Verification that these objectives have been met and satisfied should provide the final indication that the project is complete and successful.
- Design & Development Inputs: The D&D Inputs, also referred to as design requirements, refine the high-level objectives and define the customer, product, and technical requirements for the product or service against which the product will be designed and developed. This includes performance, functional, and interface requirements all of which will be used as acceptance criteria during design verification and validation activities.
Human Error Prevention
Human error prevention is a new ISO 9001 requirement defined in clause 8.5.1g, and while it is part of the ‘production’ clauses, prevention can be embedded during design and development activities to reduce human error in the product or service design. Remember that design and development requirements apply to the design of manufacturing and production processes as much as they do products and services.
Consider various techniques to prevent human error that can be implemented during the design and development of products, services, and processes including the following examples of human error mitigation tactics:
- Simplifying processes: Eliminate steps involving human input, effort, documentation, and interaction with the process or product.
- Improved tools: Provide different or improved tools and equipment to production personnel. Consider as an example the use of automatic screwdrivers with preset torque settings rather than manual handheld screwdrivers.
- Improved methods: Consider material and product handling actions to remove unnecessary movement and reduce repetitive actions.
- Automated processes: Invest in technology and other automation to reduce human interaction and involvement. Utilize robotics, cameras and vision systems, and custom material handling equipment where practical.
- Increased competence: Increasing human knowledge, skill, understanding, and overall competence as it relates to processes and products will inherently reduce the potential errors and mistakes.
- Reduced process variation: Reducing process variation will directly reduce the potential impact of human interaction with the process and product.
- Fool-Proofing: Removing opportunities for incorrect product assembly, process setup, process control, verification, quality control, etc. will reduce opportunities for mistakes. Lean refers to this as Poka Yoke.
- Increased planning effort: Investing more time and effort into the planning stages and activities will provide an opportunity to identify issues and design potential mistakes out of the product and process. Utilize tools such as FMEA (Failure Modes & Effects Analysis) and FTA (Fault Tree Analysis) to identify risks and potential process issues before development and implementation.
The standard indicates a need for retained documented information about your ISO 9001 design and development initiative. Remember that the word “retained” indicates a need for records supporting the results and outputs of processes. In this case, ISO wants you to create and retain records supporting all of your activities associated with the design & development project. Note that ISO specifically requires the following retained documented information:
- Records demonstrating that D&D requirements have been met: These records are the design verification and validation results along with verification that project objectives have been satisfied.
- Design & Development Inputs: These are generally documented as design requirements specifications defining customer, user, product, technical, and other applicable requirements.
- Design & Development Outputs: Documented design outputs in the form of product or service specifications, literature, drawings, bills of material (BOMs), approved external providers, prints, manuals, process documentation, etc. This is everything needed to describe, manufacture, test, package, label, deliver, install, and service the product or service.
- Design & Development Changes: Any time the product is changed or revised, either during development or after launch, the change should be properly evaluated, implemented, and documented.
- Design Reviews: ISO doesn’t provide any specific information on how to document design review activities, but we would recommend that you capture the agenda, logistics, participants, major decisions, and actions items to be addressed.
- Design Verification & Validation: You will definitely want to capture the methods, protocols, logistical information, results, and action items from verification and validation activities.
While the ISO 9001 standard doesn’t specifically state any requirements for documenting design & development planning, we strongly recommend that you document some type of D&D plan which at a minimum captures the requirements defined in clause 8.3.2.
As you start defining your ISO 9001 design and development processes, consider how you will manage, control, and document your activities and results. One key element of design and development initiatives that ISO 9001 doesn’t really touch on is Project Management and we will look at this disciple along with planning activities and change controls in the next series article.