This clause addresses engineering specifications. Organizations are required to document processes describing the review, distribution and implementation of all customer engineering standards/specifications, and any revisions that are related based upon customer schedules.Customer engineering standards/specifications refer to the specific technical criteria provided by customers that outline the requirements, guidelines, and expectations for the design, development, production, or quality control of a product or service. These standards/specifications cover various aspects such as product design, manufacturing processes, quality assurance, packaging, regulatory compliance, performance targets, and reliability. Adhering to these standards/specifications is crucial for suppliers or manufacturers to ensure that their products or services meet the customer’s specific requirements and achieve customer satisfaction. Non-compliance with these standards/specifications can result in customer dissatisfaction or potential loss of business.
Clause 220.127.116.11.1 Engineering specifications
The organization shall have a documented process describing the review, distribution and implementation of all customer engineering standards/specifications and related revisions based on customer-required schedule, as required. When an engineering standard/specification change results in a product design change, refer to the requirement in ISO 9001 clause 8.3.6. If the change affect production, refer to 18.104.22.168. Organization shall retain a record of the date implemented in production. Implementation shall include updated documents. Review should be completed within 10 working days of receipt of notification of engineering standards/specification changes. A change in these standards/specifications may require an updated record of customer production part approval when these specifications are referenced on the design record or if they affect documents of production part approval process, such as control plan, risk analysis (such as FMEAs) etc.
Under IATF 16949, the control of customer engineering standards/specifications is an important aspect of managing quality in the automotive industry. For compliance of this clause, you need to have a documented process on management of customer engineering standards/specifications. The documented process can be anything suitable for your system. It may be a standalone flowchart, or park inside QM, Compliance Matrix, Doc Control, APQP Procedure, PPAP Procedure, ECN Procedure, or the Design and Development Procedure etc. For all changes to these customer provided documents, cross reference to PPAP documents such as Control Plans and FMEA’s. These documents may need to be revised and may require PPAP reapproval. If in doubt, check your PPAP reference manual or check specific customer requirements. Your process for engineering change control must also address any impact on lower level documents such as production work instructions. Develop appropriate linkage controls or checklist to ensure that such documents are appropriately updated.
The standard requires to establish a process to assure the timely review, distribution, and implementation of all customer engineering standards/speciﬁcations and changes. Customer engineering standards and specifications are external documents. Therefore your process for controlling external documents should also cover these documents.Any external document received or procured for the organization should be reviewed for its applicability before it is brought under control, otherwise resources could be wasted on controlling documents that have no practical use in the organization. This requirement could be placed under Contract review since any documents issued by customers form part of the contract and should go through contract review before acceptance and implementation. Timely review means 10 days, not weeks or months — therefore immediately a new customer document is received, it should be routed to a person authorized through procedures to carry out a review. It would be advantageous to set up an interface with your customers so that their documents are always routed to the same position in your company. The review should establish the applicability of the document and its impact on the contract. Any changed documents should be treated as an amendment to the contract and processed accordingly. As with all controlled documents, a distribution list for customer documents should be maintained so that copies can be withdrawn, replaced, or amended when required.
While the specific requirements may vary depending on the organization and customer expectations, here are some general guidelines on how to control customer engineering standards/specifications:
- Identification and Acquisition:
- Identify and obtain the latest versions of customer engineering standards/specifications that are applicable to your products or services.
- Maintain a documented process for reviewing, tracking, and obtaining updates to customer engineering standards/specifications.
- Documentation and Accessibility:
- Document the relevant customer engineering standards/specifications within your organization’s documentation system or controlled document repository.
- Ensure that the documented customer engineering standards/specifications are easily accessible to the personnel who need to refer to them.
- Implement measures to prevent unauthorized access, loss, or damage to the customer engineering standards/specifications.
- Review and Understanding:
- Review the customer engineering standards/specifications to understand their requirements, expectations, and any specific product or process characteristics that need to be addressed.
- Communicate the customer engineering standards/specifications to the relevant personnel, including those involved in design, development, production, and quality control.
- Compliance and Implementation:
- Ensure that the organization’s products, processes, and quality management system are aligned with the requirements specified in the customer engineering standards/specifications.
- Establish controls and procedures to ensure compliance with the identified requirements.
- Implement necessary actions, such as design modifications or process adjustments, to meet the customer engineering standards/specifications.
- Change Management:
- Establish a process for managing changes to customer engineering standards/specifications.
- Monitor and track updates or revisions to customer engineering standards/specifications and evaluate their impact on the organization’s products, processes, and quality management system.
- Implement necessary actions to address the changes, including updating documentation, modifying processes, or communicating changes to relevant personnel.
- Verification and Validation:
- Establish methods for verifying and validating compliance with customer engineering standards/specifications.
- Conduct regular checks and audits to ensure that products and processes meet the requirements specified in the customer engineering standards/specifications.
- Document the results of verification and validation activities as evidence of compliance.
- Record Keeping:
- Maintain records of the customer engineering standards/specifications used for design, development, and production.
- Retain these records for the specified period according to your organization’s record retention policy.
It is important to note that these guidelines should be adapted to your organization’s specific needs, the requirements of relevant customer engineering standards/specifications, and any legal or regulatory obligations that apply. Consultation with customers and legal counsel, as well as periodic reviews of customer requirements, will help ensure effective control of customer engineering standards/specifications.