Identifying the status of process outputs with respect to monitoring and measurement means having a clear indication that can tell us whether or not an output conforms to the specified requirements. Identifying the status of an output therefore allows us to distinguish outputs that have been verified and found to be compliant from those that have not been verified or that have been found to be non-compliant.
Measurement does not change an output, but it changes our knowledge about it. Therefore, it is necessary to identify which outputs are compliant and which are not, in order to avoid them being mixed together or delivering something that has been found to be non-compliant to the customer. The most common method for indicating the status of the output is to apply labels to the product or to the containers that contain it.
Green labels are often used to identify acceptable products, while red labels indicate scrap material. The labels must remain affixed until the product is packaged or passed to the next stage of the process. The labels should be attached in a way that prevents them from detaching during any handling of the product.
If the labels need to be removed during further processing, the details should be transferred to the registrations of changes to products, so that - later on - the status of the components can be checked through them. At the time of shipment, the status of the product should be clearly visible. Any product without identification of its status should be temporarily placed in quarantine until it is re-verified and judged to be compliant. When walking through the production departments of a company, it should always be possible to identify which items are awaiting verification, which have already been verified and found to be compliant, and which have been judged non-compliant.
Production is the place where this type of identification is essential because it is precisely here that errors can occur. In other places, where it is somewhat unlikely to make mistakes, the identification and traceability of the status of a product may not be necessary or may not need to be so explicit. In some situations, the location of an item may constitute adequate identification of the status of the item; however, these positions must be clearly designated as, for example: "Awaiting Inspection," "Accepted," and "Non-Compliant."
In any case, it would be good to also provide status identification labels to avoid the unintentional placement of non-conforming items in the position of conforming ones. Once a product is prepared for shipment, it does not require to be identified in this way, unless it is returned and must re-enter the production process for repair or another action. Identifying the status of an output is not just a matter of attaching a label to an item.
The status should be marked by a signature, a stamp, a unique password on electronic records, or another way of identifying who authorized the passage of the product to that verification status. Regarding the identification of the status in the provision of a service in which there are elements waiting to be checked, it is necessary to behave in the same way to warn users that they cannot use a certain service because it has been found non-compliant.
Public services, for example, are closed during cleaning, and a sign is placed in front of the entrance to prevent someone from entering them erroneously. Similarly, in hotels, rooms that are not yet ready are identified so that people do not enter them and encounter a flaw in the provision of the service. If there is a possibility that a service that is not yet ready to be provided may be inadvertently perceived as usable, measures should be taken to mitigate this risk. Services that, instead, are based on products should carry a label or a warning to denote their usability.
A bank ATM is an example in which a warning is displayed when the machine is out of service. In some cases, customers may need to be informed by letter or phone call, while for software, the verification status can be indicated with a comment or in the records that attest to its compliance with requirements.
Demonstrating that the status of outputs has been correctly identified with respect to monitoring and measurement during production and the provision of services can be done in this way:
- presenting proof of the existence of a process for identifying the verification status;
- selecting a representative sample of items in the various stages of production and service delivery and demonstrating that their verification status can be correctly determined
Traceability, as we have seen, provides an organization with the ability to track something through a process along its course (forward or backward) and determine, if necessary, its origin, its history, and the conditions to which it has been subjected. Traceability may be a requirement of the customer, of law, or related to the reference standards, or it may simply be a requirement of the organization to conduct in-depth investigations when events do not proceed as planned to find the root cause of the problems.
Traceability is essential to allow for any corrective actions, a product recall, and defense in the event of product liability claims but also to control processes.
Providing traceability for each product can be an onerous task because it is really useful only when the chain remains intact. For this reason, it can also be expensive to maintain over time.
The traceability system, therefore, should be carefully thought out so that it is as economical as possible. It does not make much sense, in fact, to maintain an elaborate system if it is not absolutely necessary, unless the survival of the company does not depend on it. However, if a failure occurs and you want to avoid it happening again in the future, it will be necessary to trace the individual components through the supply chain or to which operation on which component was not performed correctly to exclude any involvement of other products that may be affected by the problem.
To demonstrate that, when traceability is a requirement, the identification of outputs is controlled and that all the necessary documented information is retained, you can:
- present proof of the existence of policies that establish what must be traceable;
- present procedures that prescribe the conventions used to provide the necessary traceability;
- select a representative sample of items that have been designated as traceable and, using the codes established by following the path backwards through the records, demonstrate that there is an unbroken chain that goes back to the intended source