Newsletter archive / Medical Device
English adaptation of the one-point section from the Japanese Medical Device newsletter, issue 326. Original issue: 2026-10-09. English adaptation: 2026-10-18. This English version was prepared for the website; it was not sent as an English newsletter.
A serious product problem and a minor-looking record discrepancy are both put through the same investigation, with the same depth and the same amount of time. The process may look consistent, but consistency of form is not the same as sensible allocation of effort.
Prioritise effort, not compliance
A risk-based approach starts by identifying the applicable requirements. It then uses the potential impact and available evidence to decide the nature and extent of the controls. It does not select which obligations are convenient to follow.
People, time and budgets are finite. An organisation needs basic controls across the system, alongside deeper attention where a failure could have more serious consequences or where the evidence shows a recurring weakness.
Look beyond labels
For a supplier, assess the contribution of the supplied item to product quality and safety, together with the supplier’s performance. A modest-looking packaging component may have a critical function. The item’s name or purchase price alone is not enough to determine the attention it needs.
For internal audits, consider the importance of the activity, previous findings and emerging concerns when planning coverage. For reported problems, begin with the required recording and evaluation steps, then determine an appropriate investigation and action. Any mandatory reporting or other obligation needs its own assessment.
CAPA counts do not tell the whole story
A large number of corrective and preventive action records is not proof of strong control. Opening every issue as an equally extensive CAPA can obscure the problems that need the most attention. Reducing the count by overlooking necessary action is equally unhelpful.
Consider impact, recurrence and possible effects on other products or processes. Explain the chosen response and preserve the relevant evidence. An issue handled outside a separate CAPA record may still need correction, evaluation, trending or follow-up.
Keep the assessment open to new evidence
A risk assessment is not a permanent label. New field information, an adverse trend or a change in the process can justify a different priority. Revisit the rationale when the evidence changes, and check whether the action had the intended effect.
The practical question is: can the team explain why this level of attention is appropriate, while showing that the necessary controls and applicable requirements have been addressed?
Adapted from the Japanese newsletter archive. Promotional sections are omitted. Examples illustrate working practices; product- and market-specific requirements should be checked separately.