ISO 9001 Design Outputs
Now that the product design is complete, the next step is to verify and validate the product and move it into production. Also, don’t forget to complete any formal design reviews during these development stages. This article will help define design outputs and explore the transfer of the finished design into the production environment. In parallel to transfer activities, product and process verification and validation efforts should be happening.
So, at this point, the product design should be completed and ready to move into production. All development prototyping and bench testing is complete and indicates that the design is robust. Also, all production processes should be established, implemented, tested, optimized, and ready for process verification and validation efforts.
The result of the actual design and develop work is the design output which includes:
- The product (or service) itself,
- Product packaging, labeling, and literature,
- The processes needed to produce, deliver, install, and service the product,
- All the necessary artifacts and specifications which define the product or service characteristics and associate production processes.
The figure above provides an overview of the basic elements of the ISO 9001 design and development requirements. This diagram shows that the design outputs must meet and satisfy the design inputs (requirements) which is demonstrated through design verification activities.
When design outputs fail to satisfy inputs, something must give. Either the design inputs must be revised and re-approved, or the product design must be changed to meet the established requirement specifications. Either way, verification and validation, where applicable, must be repeated to demonstrate effective compliance between the design inputs and outputs.
The design output will generally include a significant amount of documentation such as:
- Technical drawings, blueprints, and other engineering artifacts,
- Bills of material (BOMs),
- Product specifications,
- User instructions / product manuals,
- Manufacturing instructions and methods,
- Installation and service instructions,
- Lab or engineering notebooks,
- Process maps or flowcharts,
- Troubleshooting, repair, and service documentation,
- Safety information, labels, or warnings,
- Packaging and labeling specifications,
- Shipping specifications,
- Product testing data and results,
- Expiration or product lifecycle specifications,
- Cleanliness and/or environmental specifications,
- Training and competency requirements.
Other outputs might include:
- Prototypes or pilot products,
- Computer code or software programs,
- Product machine code,
- Test equipment and fixtures,
- Environmental or cleanliness control equipment,
- Equipment for product or material management (handling, storage, etc.).
The output also includes the production (product or service) processes which will produce the product and/or deliver the developed services. This might include:
- Methods and processes required to produce the product,
- Production equipment, tools, and methods,
- Facilities, utilities, environmental controls and criteria, etc.,
- Verification methods and acceptance criteria,
- Documented information (procedures, work instructions, workmanship standards, forms, etc.),
- Monitoring and measurement requirements, methods, equipment, and acceptance criteria,
- Competency requirements and trained personnel,
- Handling, preservation, identification, and traceability requirements and methods, where applicable,
- Approved external providers,
- Purchasing / procurement requirements,
- Process controls and where needed, validated processes,
- Established actions to prevent human error (mistake proofing),
- Methods, processes, and infrastructure for post-delivery activities.
As stated in the list above, the design outputs must define the methods, stages, equipment, processes, and acceptance criteria for verification of received external provisions and for verification of product conformance during production and prior to release to customers. This includes all the monitoring and measurement resources needed to complete verification activities.
It is important to clarify the difference between design outputs and design deliverables. Design outputs satisfy design inputs while design deliverables satisfy planning (Design & Development Plan) requirements. Examples of design outputs include assembly drawings, component and material specifications, production and process specifications, software (disk, master EPROM, etc.), work instructions, and quality assurance specifications and procedures. Examples of design deliverables include design outputs, requirements specification, design inputs, design and development plans, quality plans, risk management plans and reports, design review reports, and test protocols and reports. Our ISO 9001 eCoach Learning System provides additional clarification between these different deliverables.
ISO 9001 also states that the design outputs must specify the characteristics of the products and services essential for their intended purpose and safe and proper provision. That’s a mouthful, so let’s take a minute to break this statement down.
First off, whether or not ISO 9001 or other government regulations require it, every company should invest the requisite time, effort, and money to verify and demonstrate that products are safe and that they will do what they are said to do (effectiveness). That is the reason that ISO 9001 included this specific requirement in the standard.
ISO 9001 requires that these essential characteristics be specified and that they be documented, usually in some type of specification. I recommend the following steps to ensure essential safety and intended use characteristics are adequately identified and documented:
- Design & Development Plan: Define the methods and tools to be used to identify the essential product characteristics. Also define the meaning and context of “essential characteristics” so the development team is aware of what these characteristics are and how to identify and recognize them.
- Design & Development Inputs (Requirements): Be sure to capture all design input requirements which are associated with essential product characteristics. Denote these requirements in some manner so they can be readily identified within the requirements specification document(s). It will be critical that these essential requirements are properly verified and validated.
- Design Review: Design reviews provide a great platform for the team to discuss known essential characteristics and also identify others that have been missed or overlooked. Be sure to incorporate newly identified characteristics into requirements specifications and design output documentation.
- Design Verification & Validation: All product requirements must be verified to demonstrate that the design output meets the established design input requirements. The product must also be validated to demonstrate that the product meets the customer/user requirements along with the intended use. Make sure that verification and validation methods and results associated with essential characteristics are appropriate and documented.
- Risk Assessment: While not specifically required by ISO 9001 Design & Development requirements, risk management (risk-based thinking) is required where applicable throughout the organization. Also consider clause 8.3.3e (Design & Development Inputs) which requires the consideration of potential consequences of failure due to the nature of the products or services (i.e. risk). One great way to determine these potential consequences is through use of risk assessment tools such as FMEA (Failure Modes and Effects Analysis), risk / hazard analysis (ISO 14971 / ISO 31000), FTA (Fault-Tree Analysis), or any other appropriate risk assessment method or tool that fits your products and organization. Be sure to incorporate essential characteristics identified through risk assessment activities back into design input requirements, design reviews, and design outputs.
In the end, you need to define a method for identifying those product characteristics which are essential to ensure a product is safe for the user and one that meets claimed functionality and performance. How you do that is up to you to define, but just ensure that your methods are established and results are documented and verified.
So now that you have designed and documented your product, it must be put into production and delivered to customers. The ISO 9001 design and development clauses don’t site specific requirements for design transfer, but other similar standards do, and it certainly is a topic that should be considered. Also, remember that the ISO 9001 design and development clauses apply as much to the development and implementation of your production processes as they do to your product development activities. The development of production processes should be seamlessly integrated with and parallel to product development activities.
Design transfer is the transition and translation of the ISO 9001 design outputs into the production realm and should ensure that product and service designs can be produced and delivered to customers in an effective and conforming manner. ISO 9001 does, in a way, cite design transfer requirements in and through other clauses:
- 3.1: Establish, implement, and maintain a process appropriate to ensure provision of products and services,
- 3.2h: Planning for the requirements for subsequent provision of products and services,
- 3.5b: Ensuring design outputs are adequate for the provision of products and services,
- 5.1a1: Define the characteristics of the products produced, services provided, and activities performed.
In fact, many of the requirements under section 8.5.1, Control of Production and Service Provision, can often originate from and be defined by the output and results of design and development activities.
Production specifications must ensure that manufactured products are repeatedly and reliably produced within product and process capabilities. The process of encapsulating knowledge about the product into production specifications is critical to product quality.
Concurrent to product design, the project team should complete the design and development of the production processes and ensure that the product design is correctly translated into production specifications.
For many development projects, the design transfer process includes a qualitative assessment of the completeness and adequacy of the production specification which is completed through the use of design reviews and completion of risk assessment activities such as Process Failure Modes and Effects Analysis (PFMEA).
The design transfer process should also verify that all applicable documentation which constitute the production specifications are reviewed, approved, and implemented.
ISO 9001 Design Outputs constitute the final product (or service) to be placed into production and delivered to the end customer along with all the supporting documentation needed to produce, maintain, verify, deliver, and service the product. It also includes the processes for producing the product including equipment, facilities, instructions, test stands, verification activities, etc. It is the recipe for producing the product and it must be transferred into production in a manner that ensures the production output is under control and compliant to established specifications at all times. As always the EBS ISO 9001 eCoach Learning System provides additional guidance, methods, and tools to development and implement your ISO 9001 Quality Management System.