ISO 22716 Section 14 Explained: Complaints and Recalls

By Robert Low, Lead Management System Specialist

Section 14 of ISO 22716 covers two related but distinct topics — complaints, which are the everyday signal that something may have gone wrong, and recalls, which are the serious, comparatively rare response when a quality issue genuinely requires pulling product back from the market.

This post is part of a series working through ISO 22716 section by section. The series summary with links to every section is available at the end.

What the Standard Covers — Complaints

All complaints falling within the scope of the standard and communicated to the plant need reviewing, investigating, and following up as appropriate. Authorised personnel need to centralise all complaints — meaning complaints should not be scattered across customer service, sales, and quality with no single point bringing them together.

Each complaint concerning a product defect needs keeping with its original details and follow-up information, with appropriate follow-up completed on the specific batch concerned. Investigation and follow-up needs to include steps to prevent the defect recurring, and checking whether other batches might also be affected, where appropriate. Complaints also need periodic review — at least to check for trends or recurrence of a particular issue, not just handling each one in isolation.

What the Standard Covers — Recalls

When a recall decision is made, appropriate steps need taking to complete the recall within the standard’s scope, with corrective action implemented as part of the process. Authorised personnel need to coordinate the recall, and recall operations need to be capable of being initiated promptly and carried out in a timely manner.

Where a recall could affect consumer safety, the appropriate authorities need notifying. Recalled product needs identifying and storing separately, in a secure area, while awaiting a decision on disposition. The recall process itself — not just individual recalls when they happen, but the process as a whole — needs periodic evaluation to confirm it would actually work if needed.

Where This Commonly Goes Wrong

The most common gap on the complaints side is trending. Individual complaints often get handled reasonably well in isolation, but the periodic review looking for patterns across complaints — three minor packaging complaints in a month that, on their own, seemed unconnected but together point to a developing equipment issue — gets skipped because nobody owns that broader analysis.

On the recall side, the most common gap is a recall procedure that has never actually been tested. A documented process that looks complete on paper can still fail in practice if nobody has ever run a mock recall to check whether traceability records actually allow the affected batches to be identified quickly, or whether the notification chain to customers and authorities genuinely works under time pressure.

How This Connects to the Rest of the System

Complaints are, in effect, externally-sourced nonconformances and should flow into the same investigation and CAPA process used for internally-identified issues. Recall capability depends entirely on the production control and traceability systems covered earlier in this series — if a batch cannot be traced quickly and accurately from finished product back through to raw materials and forward to specific customers, the recall process described in this section cannot function regardless of how well it is documented.

This post is part of the Cornerstone ISO 22716 series. See the full series summary with links to all 16 sections.