Understanding Sections 8.5 and 8.6
Production and service provision and release
This is an educational article on Section 8.5 of ISO 9001, entitled “Production and service provision” and Section 8.6, entitled “Release of products and services”.
The purpose of this article is to give you an understanding of what these sections require.
This article is directed towards:
- Those responsible for compliance to sections 8.5 and 8.6.
- Those responsible for production or service provision and release.
- Others interested in understanding sections 8.5 and 8.6.
Section 8.5 is entitled “Production and service provision” and is divided into six sections entitled:
- Control of production and service provision
- Identification and traceability
- Property belonging to customers or external providers
- Preservation
- Post-delivery activities
- Control of changes
Also included in this training is Section 8.6 “Release of products and services”.
The first section is entitled Control of production and service provision and it requires you to control production and service provision through:
- Documentation of the characteristics of products or services to be provided
- Documentation of the results to be achieved
- Employment of monitoring and measuring resources and activities (addressed further in Section 9.1)
- Validation of processes where the outputs cannot be verified by monitoring or measurement
- Provision of suitable infrastructure (addressed further in Section 7.1)
- Appointment of competent persons (addressed further in Section 7.2)
- Implementation of actions to reduce human error
- Implementation of release, delivery, and post-delivery activities
Many of these requirements overlap with other sections of the standard, but having them grouped here emphasizes the importance of the interaction of these various processes to ensure controlled production and service provision.
Section 8.5.2 is entitled “Identification and Traceability”.
What is identification?
Identification refers to your ability to identify outputs at certain stages of production or service provision in order to verify that those outputs are meeting requirements as planned.
Section 8.5.2 requires you to:
- Identify outputs (at those pre-determined relevant stages), and then
- Identify their status (with respect to conformity with requirements).
What is traceability?
Traceability refers to your ability to trace, through recorded identification data, the history, distribution, application, use or location of an item or its characteristics throughout production or service provision.
Or in other words, to trace products, parts, materials and services with respect to their past history, distribution, location, use, or application.
Section 8.5.2 requires you to:
- Trace outputs, and
- Retain the records necessary to enable that traceability.
However, this only applies when traceability is an internal or customer requirement! If traceability is not a requirement of your own, or of a customer, then this is not a requirement of ISO either, you may exclude it.
So why put it in the standard then?
Because ISO thinks that traceability is important and wants to prompt you to think of it. Before dismissing traceability as a requirement for your company, ensure that it truly does not add any value to your quality goals and objectives. Otherwise, considering implementing some degree of traceability.
Common methods for identifying items for traceability include:
- Part marking, such as by etching, ink, or some other method
- Bag and tag methods, especially for small parts
- Tagging
- Stamping
- Using marked containers
- And so forth
The history of the item is then often traced through some other means, such as:
- A software system that tracks the progress of the item through all stages of production
- Through traveling documents that follow the item throughout production and collect data
- Through some other means
Section 8.5.3 is entitled Property belonging to customers or external providers, and requires you to exercise care with the property of others while it is under your control.
And if the property is lost, damaged, or otherwise found unsuitable for use, you are required to:
- Report to the owner
- Retain documented information of what occurred
Section 8.5.4 is entitled Preservation, and it requires you to preserve the outputs of production or service provision to ensure conformity until delivery to the customer.
Preservation can include properly identifying, safe handling, contamination control, proper packaging, clean storage, secure transportation, and so forth.
You can see how this might overlap with identification and traceability in how it is implemented.
Section 8.5.5 is entitled “Post-delivery activities.”
Post-delivery activities are activities which your organization is obligated to perform after delivery of the product or service.
Post-delivery activities can include actions pursuant to warranty provisions or contractual obligations, maintenance services, or supplementary services such as recycling or final disposal.
You are required to determine the extent of you post-delivery obligations. Consider the following when making this determination:
- Statutory and regulatory requirements
- The potential undesired consequences associated with your products and services
- The nature, use and intended lifetime of your products and services
- Customer requirements, and
- Customer feedback
Section 8.5.6 is entitled “Control of changes” and it requires you to review and control changes for production or service provision, and when making changes, to retain records of:
- The results of the review of changes
- The person(s) authorizing the change
- Any resulting action from the review
The purpose is to reduce the threat that the changes will adversely impact conformity with requirements.
Section 8.6 is entitled “Release of products and services” and it requires you to not proceed with the release of products or services until the control requirements have been met, and to retain records of:
- Conformity with acceptance criteria, and
- The person authorizing the release
For more information on how to implement this section, watch our implementation videos for sections 8.5 and 8.6, and review our template library for examples.