Newsletter archive / Quality and Regulatory
English adaptation of the one-point section from the Japanese Quality and Regulatory newsletter, issue 431. Original issue: 2026-10-16. English adaptation: 2026-10-18. This English version was prepared for the website; it was not sent as an English newsletter.
When several teams review the same record, it is tempting to assume that each extra check adds the same amount of protection. But if everyone repeats the same search for transcription errors, the organisation may spend considerable effort without examining why those errors reach the final record.
Ask a different question at each level
Routine controls ask whether work and records meet the defined criteria, and what correction is needed when they do not. Quality-assurance activities ask whether there is a sound basis for confidence in the result and whether important decisions and controls are working. An audit steps back to examine the system: its design, implementation and effectiveness.
These descriptions are a practical way to discuss responsibilities, rather than a universal organisation chart. The allocation of duties depends on the activity and applicable requirements. A team’s title alone does not establish who is responsible for a particular decision.
Include QA processes in the picture
QA performs important work of its own. Its review process, decisions, escalation arrangements and records can therefore be examined as part of a quality-system assessment. For an objective assessment, plan who can evaluate that work without simply approving their own previous decisions. Confirm any formal auditor-independence requirements separately.
Move from the error to the control
Suppose an auditor finds a copied result that does not match the source. Correcting the record matters, but the review should also ask how the mismatch arose and why the earlier control missed it. Were the criteria clear? Was the source available? Did the reviewer understand the task? Is there a wider pattern?
A useful finding distinguishes the observed evidence from an assumed cause. It describes the affected control and identifies what needs investigation. Finding a mistake does not, by itself, prove that every part of the system is ineffective.
A practical check
Take one recent audit report. Does it only list isolated mistakes, or does it also explain what the evidence says about the underlying process? Then examine the review responsibilities. Each layer should have a clear purpose, with its depth and independence appropriate to the task.
Adapted from the Japanese newsletter archive. Promotional sections are omitted. Examples illustrate working practices; product- and market-specific requirements should be checked separately.