AS9100: what it asks of a calibration register

The resources needed for monitoring and measurement to give valid, reliable results are identified and provided; they are suitable for the task and kept in good order, and records show they are fit for purpose. 9100 adds a process for calling in monitoring and measuring equipment that needs calibration or verification, and a register of such equipment showing its type, unique identity, location, and the method, frequency and acceptance criteria for calibration or verification; the register covers test hardware and test software, automated test equipment, plotters that produce verification data, and equipment owned by employees or supplied by customers. Where traceability of measurement is required, or the organization regards it as essential, equipment is calibrated or verified at set intervals against standards traceable to international or national standards (with the basis recorded where none exists), marked to show its status, and protected against adjustment, damage or deterioration. Under 9100, calibration and verification take place in suitable environmental conditions. If equipment is found to be unfit, the organization establishes whether earlier results were compromised and acts accordingly.

Documented information that the QMS and the standard require is controlled so that it is available and fit for use at the place and time it is needed and is properly protected. Control covers how it is distributed, accessed, retrieved and used; how it is stored and preserved, legibility included; how changes are controlled; and how long it is kept and how it is disposed of. External documents judged necessary are identified and controlled, and records kept as evidence of conformity are guarded against accidental change. Under 9100, obsolete documents retained for any reason are kept from accidental use by removing them or by suitable marking or controls, and where documents and records are held electronically, processes are defined to protect the data against loss, unauthorized or accidental change, corruption and physical damage.

Outputs that fail to conform are identified and controlled so they are not used or delivered by mistake; this covers nonconforming product made in-house, received from an external provider or found by a customer, and action matches the kind of nonconformity and what it affects, including where it is found after delivery. Under 9100, the process for controlling nonconformities is kept as documented information and sets out: who is responsible for, and authorized to, review and decide on nonconforming output, and how the people who make those decisions are approved; containment of any effect on other processes, products or services; prompt notification of the customer and relevant interested parties about nonconformities affecting products already delivered; and corrective actions for nonconformities found after delivery. The options are correction; segregation, containment, return or suspension; telling the customer; and acceptance under concession, authorized by a relevant authority and, where applicable, the customer as well. Under 9100, a decision to repair or to use as is may be carried out only once approved by someone authorized to represent the design organization or holding delegated design authority, and, where the nonconformity departs from contract requirements, once the customer has authorized it. Scrapped product is marked clearly and permanently, or kept under positive control until it can no longer be used; counterfeit and suspected counterfeit parts are controlled so they cannot find their way back into the supply chain; corrected outputs are verified again; and records describe the nonconformity, what was done, any concessions granted and who decided.

When a nonconformity arises, complaints included, the organization: acts to contain and correct it and to handle what follows from it; assesses whether its causes need removing, by reviewing and analysing it, establishing the causes (under 9100, including causes linked to human factors) and checking whether similar nonconformities exist or might arise; carries out the action needed; checks that the action worked; brings risks and opportunities up to date; and alters the QMS where required. Under 9100 it passes corrective action requirements on to any external provider responsible for the nonconformity, and takes particular steps when corrective action is late or ineffective. Actions suit the effects of the nonconformity. 9100 requires the processes for managing nonconformities and corrective action to be kept as documented information, and records are kept of each nonconformity, the actions taken and the outcomes.