Identification, Traceability, and Preservation
As we dig into the detailed ISO 9001 production control clauses and requirements, some organizations, especially the service-oriented ones, might find that some of these requirements don’t apply to their specific operations. Be careful though, as some of these requirements, while they may not appear to apply on the surface, actually can be applied to your business, and taking an exemption to a clause that is truly applicable can cause problems during your ISO 9001 certification audit.
Let’s take a look at how ISO 9001 wants you to manage (control, label, track, etc.) your raw material, in-process (WIP), and finished goods.
As we often do, we’ve combined a couple of related clauses into one process to simplify things. In this case, we’re discussing the following ISO 9001 clauses:
- 5.2 – Identification and Traceability
- 5.4 – Preservation
It only makes sense to properly label and control all products, materials, assemblies, components, supplies, etc. (process inputs and outputs) throughout your production activities and environment. The ISO 9001 inventory control requirements state that identification should be of suitable means to ensure conformity of products and services. How you identify your process outputs is entirely up to you as long as it is effective and appropriate for your processes and products. You can use tags, stickers, labels, documentation (travelers, routers, work orders), or any other method that works for you. For bulk components or assemblies, you can use containers, tubs, or specific locations as long as they are clearly identified and prevent mix-ups or cross contamination. Even consider going high-tech and using bar codes or RFI tags.
ISO 9001 does cite one specific requirement defining the need to identify the status of outputs in regard to monitoring and measuring requirements. This is usually two pieces of information: Has the output been monitored or measured as required and what were the results of the activity? Usually the results of any verification activity are captured in various production records such as work orders, travelers, checklists, verification or inspection worksheets, etc. Remember that these don’t necessarily need to be hardcopy paper documents but can be captured using appropriate electronic databases and other production software control systems. You could also complete this task by placing items in containers according to the test results. These are just a few examples and there many other methods. Use the one that works for you.
This is a unique ISO 9001 inventory control requirement which may or may not apply to your organization, products, or services. You will need to determine if it does apply, and if so, what type of traceability and to what extent. The need for traceability is usually driven by your own internal requirements, customer requirements, or regulatory requirements (think medical device, pharma, automotive, or aerospace).
Traceability provides a method for determining some of the specific elements that went into or were associated with your product(s). This might involve traceability for individual products through serial numbers to production batches or lots of material produced. Traceability information can be related to:
- Raw materials used (external provider name, lot / batch numbers, serial numbers, heat numbers, production dates, locations, etc.),
- The date, time, location, production line, tooling or equipment used, etc. within your own production processes,
- The people who produced the product,
- The various test and measuring equipment used to verify product,
- Any other information deemed critical to complete complaint investigations, corrective actions, other resolution of other issues at a later time.
Traceability doesn’t require tracking and control of all items that go into your products but should be established for those items you have defined as key or critical to the product. These key or critical inputs and outputs are usually determined through product development (design & development) activities such as design reviews and risk assessment.
Traceability also comes in two varieties:
- Backward Traceability: This is the more common type and provides information about the processes and materials that went into producing a product or delivering a service. This is generally used to investigate issues and root causes of product failures in the field or customer’s hands.
- Forward Traceability: This one is usually associated with regulated industries and products, and informs an organization about the customers who received specific individual products or batches of product. This allows organizations to pinpoint which customers have received a specific product, range of products (serial numbers) or lot / batch of products and take action such as recalls or notifications about product issues or nonconformities.
Unless you operate in a regulated industry, chances are that backward traceability is the only type that applies to your products and services.
This is another no-brainer and you probably already have established some good practices and requirements for how you identify, handle, package, store, ship, deliver, preserve, and protect your products. These ISO 9001 inventory control requirements state that any materials, supplies, or items used in the delivery of services also need to be considered with the preservation requirements.
Probably the best approach to satisfying this requirement would be to walk through all the phases, processes, and steps associated with production and delivery of your products and services. Start with receipt of incoming materials from external providers and follow each process step through to delivery of products to end customers. As you complete this exercise, determine the requirements to ensure product is preserved and protected from damage, contamination, or loss.
Consider how products should be handled during processing and moved between processes? Are there requirements that limit physical damage (drop, shaking, spillage), exposure (temperature, humidity, light, sound), or cleanliness or sterilization. What are the methods of transportation within your facility, between facilities, and during delivery to customers? How do products need to be packaged, boxed, palatalized, labeled, etc.?
If your products are sensitive, fragile, or have specific shipping constraints, restrictions, or requirements, consider completion of packaging and shipping validation studies to ensure your packaging an shipping specifications and methods are sufficient to protect your products. If products must retain a certain level of cleanliness or sterility, complete the appropriate validation activities to demonstrate conformance where applicable. You might also implement robust controls for external providers who supply packaging materials, sterilization services, and transportation. See our previous article “ISO 9001 Control of External Providers” for additional information on controls for suppliers.
We often see where organizations cover packaging and shipping requirements well but overlook internal storage requirements and methods. Are your internal storage areas well protected and controlled? Is the environment sufficient to prevent deterioration or contamination? Is security adequate to prevent theft or loss? How is stock rotation managed and controlled (First In, First Out)? What about fire protection, pest control, cleanliness, etc.
Control of Externally Owned Property
This should be a relatively short and easy process to establish unless you receive and control a significant amount of property form external sources. While not specifically an ISO 9001 inventory control clause, the bottom line is that ISO 9001 (clause 8.5.3) expects you to manage and control anything of value or interest that you receive from external sources, especially things considered proprietary or which must be disposition at some point in the future.
External sources are defined by ISO as either customers or external providers, but you can include any applicable external stakeholder in this group. Property that is provided might include:
- Consigned materials, components, or supplies to be incorporated into products,
- Information or data used to manufacture products or deliver services (legal, financial, etc.),
- Information, prototypes, specifications, models, etc. used by engineering or product development,
- Equipment, machines, or tools, etc.
While the property is in your possession, ISO requires you to care for, protect, identify, and manage the property. Develop an effective process for identifying, tracking, and controlling the property while it is in your possession. You might want to assign an internal resource or function responsible for the property while in your care. Engineering might be assigned responsibility for control of specifications, prototypes, or models form customers. A spreadsheet might be used to track external property. You can access an example External Property Tracking Log from the EBS Free Members Library. Be sure to modify the format and content of this tool to fit your organization and process.
Also determine the final disposition for the property and ensure that appropriate action is taken when required. This might be returning the property to the source, using it for production, or delivering it to customers. For information or data in your possession, you might be required to destroy it, especially information that is considered confidential. While not specifically required, consider capturing and retaining some type of record of what action was taken, when it was taken, and who completed it.
ISO 9001 specifies that when external property is lost, damaged, found to be unsuitable for use, you must report this to the external property owner and retain documented information concerning the issue and action taken.
No matter what you produce or deliver to your customer, it is critical to establish ISO 9001 inventory control processes to identify, control, and protect materials, products, and other key production resources while in your possession and use. This includes controlling items through activities such as delivery, installation, and servicing where applicable. Also, be sure to establish a process to track and control property obtain from customers, suppliers, and any other key stakeholders (Interested Parties).