Production and Measuring-Equipment Controls
Production controls help turn an approved design into conforming devices. Measuring equipment helps provide evidence that the work achieved its intended result.
This lesson follows both parts of that system. Watch the difference between identifying a product and knowing its acceptance status, between inspecting an output and validating a process, and between repairing an instrument and evaluating the results it produced earlier.
Control the conditions of production
Production and service activities are planned, performed, monitored, and controlled. Depending on the activity, controls include current instructions, suitable facilities and equipment, trained personnel, specified process parameters, and monitoring.
Labeling, packaging, and release arrangements also matter. The detail should reflect the consequences of failure.
The controls work together. An instruction may be current while the equipment is unsuitable, or a trained person may lack the information needed for the next decision. Review the conditions as a connected system that supports the work.
Record what was produced and accepted
A device or batch record identifies the quantity manufactured, the quantity approved for distribution, and the required traceability. The record is verified and approved.
These connections help distinguish what was made from what was accepted. Production activity alone does not establish that every output is ready for distribution.
Useful records connect the product with the relevant work and decisions. They support the ability to understand how a device or batch was produced and the basis for its acceptance.
Identity and status are different
Identification answers which product this is. Acceptance status answers whether required checks have passed and whether the product is available for the next activity.
A product can be clearly identified and still be awaiting acceptance. Its serial number does not make the acceptance decision.
Keep held or rejected material from being used inadvertently. The people handling the product need a reliable way to recognize its status, as defined by the organization's controls, so that identification is not mistaken for permission to proceed.
Traceability connects the history
Traceability connects recorded identities to relevant materials, processes, and distribution history. Its required extent is defined in the organization's procedures using applicable requirements and risk.
A serial number is useful only when the supporting records connect it to the information that must be traced. An isolated identifier cannot reconstruct that history.
The practical question is whether the organization can follow the needed connections. This becomes especially important when a material, process, or measurement concern requires identifying which products may be affected.
When later checks cannot establish conformity
A final inspection cannot demonstrate every property of every output. Process validation is required where the output cannot be, or is not, verified by later monitoring or measurement, and deficiencies would become apparent only during use or after service delivery.
Validation demonstrates that a controlled process can consistently achieve its planned result. It needs defined methods, acceptance criteria, qualified equipment and people, records, and criteria for revalidation and changes.
A successful single trial or favorable inspection result does not automatically establish that the process has been validated.
Choose equipment for the measurement
Select measuring equipment suitable for the characteristic, range, and accuracy needed. Where necessary for valid results, calibrate or verify it at specified intervals or before use against appropriate traceable standards. If such standards do not exist, record the basis used.
Make the equipment's status identifiable and protect it from damage or unauthorized adjustment.
A current calibration label is not enough if the calibration range does not cover the intended measurement. Confidence depends on suitability for the actual work as well as the equipment's control status.
Software is part of the measurement chain
Software used for acceptance measurements also needs validation of its application proportionate to risk. A familiar application does not establish that a particular calculation is correct for its intended use.
Consider the chain from the original measurement through any processing to the acceptance result. An error in that processing can affect the decision even when the instrument itself is suitable.
The Quality Manager can help coordinate the relevant evidence. The assessment needs to address what the software is being used to do in that measurement and acceptance process.
An instrument failure reaches backward
If equipment is found outside requirements, assess and record the validity of earlier measurement results. Take appropriate action for both the equipment and affected product.
Imagine a pressure gauge used to release several lots is later found out of tolerance. Recalibration addresses future use, but it does not settle whether earlier acceptance decisions were valid.
The Quality Manager coordinates identification and control of potentially affected lots, technical evaluation of measurement impact, documented disposition, and follow-up under approved procedures. The product decision follows the evidence rather than an assumption that every earlier result is either valid or invalid.
What to carry into your work
Look for controlled production conditions, clear product status, and records that connect the required history. Use process validation where needed and measuring equipment suited to the task. When a measurement problem appears, consider both future use and the earlier decisions that may be affected.
This lesson draws on the AAMI and ISO practical guide to ISO 13485, sections seven point five through seven point six. The examples are educational. Applicable requirements and your company's approved procedures govern actual work.
SOURCE CREDIT AAMI/ISO 13485:2016 — Medical Devices: A Practical Guide (ISO 2017), §§7.5–7.6; purchased through ANSI. This video presents original educational explanations informed by the guide. It is not an official AAMI, ISO, ANSI or FDA course. Applicable requirements and company procedures govern actual work.