Two missing signatures, a repeated root cause and a quality manager asking for an observation

Grade against the certification body's documented grading criteria, not against the auditee's comfort. The usual definitions: a major nonconformity is the absence of, or systemic failure to implement, a required element, or a nonconformity that would result in the product not meeting requirements and is likely to recur. A minor is an isolated lapse in an otherwise effective system.

Here the evidence points to two separate findings:

1. 8.6 release of products and services - two of 15 sampled batches shipped without evidence of conformity and without traceability to the authorising person. On its own, two records could be a lapse. The operator's statement is the pivotal evidence: sign-off is done retrospectively 'depending how busy we are', which means the control is not operating as designed across the shift. Add the wrong-label complaint (same release/labelling weakness), and the pattern is systemic. Recommend major.
2. 10.2.1 nonconformity and corrective action - the same root cause was 'closed' twice and has recurred. That demonstrates corrective action was not effective and effectiveness was not verified. This is a failure of a required element and supports major.

Systemic means the failure is in the process design or its enforcement, not in one person's day. Test it: does the failure cross shifts, products or time? Does the documented process differ from what happens? You must corroborate the operator's statement rather than rely on a single remark - check other shifts and other record sets before writing 'systemic'.

Before finalising, verify that the finding is supported and that its consequences are understood:

• Extend the sample: examine 30 records across all three shifts and more than one product family;
• For the two unsiged batches: was the product actually tested, by whom, and is there an alternative record (lab results, line printout) showing conformity? Was the product released to a customer, and is the customer aware?
• Check 8.7: if conformity is not demonstrated, the product should have been treated as nonconforming - was it?
• Obtain the label verification requirement and compare it with the complaint and CAPA records;
• Read the two CAPA files in full: root cause, action, who verified effectiveness and how.

What would change the grading:

• If testing evidence exists for both batches and only the signature is missing, the finding narrows towards 7.5.3 control of documented information (records) and may be minor - but 8.6 still requires evidence of conformity and traceability to the authoriser, so it does not disappear.
• If the operator's statement is not corroborated and the other 28 records are complete, the release finding may be minor.
• If the same gap is found on all shifts and no alternative verification exists, major is firmly supported.

Also consider immediate action: if product may be nonconforming and in the market, tell the auditee at the earliest opportunity rather than waiting for the closing meeting. Do not let the grade be negotiated; let it be evidenced.

Include: requirement, evidence, and the link between them.

Clause 8.6 - Release of products and services (major) Requirement: the organisation shall retain documented information on the release of products, including evidence of conformity with acceptance criteria and traceability to the person(s) authorising the release. Evidence: of 15 batch records sampled for June–August, batches [IDs and dates] were shipped to customers without final inspection sign-off and without identification of the person authorising release. On the packing line the operator stated that the shift leader 'signs them all at the end of the week, it depends how busy we are'. Batch [ID] was despatched on [date].

Clause 10.2.1 - Nonconformity and corrective action (major) Requirement: the organisation shall evaluate the need for action to eliminate the cause of a nonconformity and review the effectiveness of any corrective action taken. Evidence: the root cause 'no label verification step' is recorded as closed in CAPA [ref, 2023] and again in CAPA [ref, 2024]; complaint [ref] dated [date] shows the same failure recurring.

Leave out: opinions about culture or attitude ('careless', 'poor discipline'); recommendations or solutions (that is consultancy); generalisations beyond the sample ('records are never signed'); hearsay from people you did not record; and any reference to the quality manager's request to downgrade it.

State the sampling basis, because it is what makes the finding auditable. Before issuing, read the statement to the process owner and confirm the facts are accurate - facts, not the grading, are what you check with them.