What this is
What is a product nonconformance report?
What is a product nonconformance report?
A product nonconformance report is the record of product that fails to meet a defined requirement, together with the decision taken about that product. It states what is wrong against the specification, how much is affected, what risk it carries to safety and legality, what happens to it, and who authorised that. It is a product record first and an investigation record second.
What is the difference between a nonconformance and a deviation?
A nonconformance means the product does not meet its requirement. A deviation means the process ran outside its set limits, which may or may not have produced nonconforming product. Both need recording, in separate records, because the deviation drives process control and the nonconformance drives a product decision. A CCP deviation with product held is both, and the two records reference each other.
What is disposition?
Disposition is the decision about what happens to the nonconforming product: scrap, rework, regrade, return to supplier, use as is under concession, or release after further evaluation. ISO 9001 cl.8.7.2 requires the record to retain the actions taken, any concession obtained, and the identity of the authority deciding. A disposition without a named authority is the most common defect in the record itself.
Scope
When is a product nonconformance report required?
This is the workhorse product record and it sits at the centre of a group of neighbours that each own one part of the response. The record identifies and bounds the nonconforming product; the hold, the rework authorisation and the concession are separate instruments because each carries a different approval.
Use this template when
- Product or material fails to meet a written specification and physically exists somewhere
- An in-process, final, weight, label, metal detection or x-ray check rejects product
- A process deviation or CCP failure has left product whose safety or legality cannot be confirmed
- A complaint or return is traced to a batch and remaining stock has to be identified and held
- Nonconforming product is discovered after despatch and the recall question has to be asked on the record
Do not use it for
- A process that ran outside its limits while the product still conformed, which belongs in the Process Deviation Report so process control and product status stay separable
- The physical hold and the release decision itself, which belong in the Hold and Release Record that this case references by its hold identifier
- What will be done to the product, which belongs in the Rework Authorization and the Rework Instruction Record because rework needs its own approval and method
- Use as is against a customer specification, which belongs in the Concession Request since only the customer can authorise a departure from their requirement
- Supplier material rejected at goods in and laboratory results outside specification, which belong in the Material Rejection Report and the Out of Specification Report respectively
Compliance mapping
Which ISO 9001 cl.8.7 requirements does this satisfy?
Nonconforming product is one of the few things almost every framework treats identically: identify it, control it so it cannot be used or delivered, decide what happens to it under a named authority, and keep the record. The differences appear once the product has left the site.
| Clause | Requirement | Where it lands |
|---|---|---|
| ISO 9001 cl.8.5.2 | Identification and traceability of outputs, so the affected quantity and its location can be bounded | Header |
| ISO 9001 cl.8.7.2 | Documented information describing the nonconformity, including the requirement not met and the actual result | The nonconformance |
| ISO 9001 cl.8.7.1 | Nonconforming outputs identified and controlled to prevent unintended use or delivery | Extent |
| ISO 22000 cl.8.9.4 | Potentially unsafe product held and released only on evidence that the hazard is at an acceptable level | Food safety and regulatory |
| Regulation (EC) 178/2002 art.19 | Withdrawal of product no longer under immediate control and notification of the competent authority where it may be unsafe | Food safety and regulatory |
| ISO 9001 cl.8.6 | Product not released until planned verification is complete, unless approved by a relevant authority and traceable to that person | Investigation and closure |
| ISO 9001 cl.10.2.1 | Reaction to the nonconformity, then evaluation of whether the cause needs eliminating and whether it exists elsewhere | Investigation and closure |
| 21 CFR 117.150 | Corrective actions including evaluating all affected food for safety and preventing its entry into commerce | Investigation and closure |
What it does not cover
- The hold itself, which needs a hold and release record that physically identifies, segregates and then releases or disposes of the stock; the hold identifier here is a pointer to it, not a substitute.
- Root cause analysis, which needs a structured method proportionate to the case; recording the investigation level and its reference is not the same as establishing why the product came out wrong.
- Corrective action and its verification, which lives in the CAPA record because ISO 9001 cl.10.2 asks whether the action worked, and closing the case cannot answer that.
- A withdrawal or recall decision, which runs on the recall plan with its own notification timescales; this record only establishes that the question must be asked.
- Customer authorisation for use as is, which must go through the concession route in writing, because a customer requirement cannot be waived internally however small the departure.
Global
Product Nonconformance Report requirements by country
Every regime obliges you to keep nonconforming product out of the supply chain. What changes by jurisdiction is what happens once it is already out: who must be told, how fast, and whether the decision to notify is yours.
21 CFR 117.150 and 117.190; 9 CFR 417.3 for FSIS-regulated product; Reportable Food Registry
Preventive controls require corrective actions that evaluate all affected food and keep it out of commerce, with records retained.
The reportable food obligation runs on a short clock once there is reasonable probability of serious harm, so the despatched and recall fields are the ones that carry regulatory exposure.
Food Safety Act 1990 s.14; General Food Regulations 2004; retained Regulation 178/2002 art.19
Duty not to sell food not of the nature, substance or quality demanded, plus a withdrawal and notification duty for unsafe food.
Composition and quality shortfalls are enforceable in their own right, so a case scored as a quality-only issue can still be an offence.
Regulation (EC) 178/2002 arts.14, 18 and 19; Regulation (EC) 852/2004
Unsafe food must not be placed on the market, traceability runs one step back and one step forward, and withdrawal is a duty on the operator.
Because the notification duty is the operator's, delaying while an internal investigation completes is itself the breach.
Safe Food for Canadians Regulations, preventive control and recall requirements
Licence holders must have written preventive controls, complaint and recall procedures, and traceability records.
The recall procedure must be demonstrably exercisable, so a case that identifies despatched product without triggering it is a preventive control failure as well as a product one.
Food Standards Code Standards 3.2.1 and 3.2.2; state and territory food acts
Food safety programmes and practices requirements, with a recall system required to be in place and tested.
Regulators expect the mock recall evidence to match the live route, so the case must use the same references and holds the tested procedure assumes.
ISO 9001 cl.8.7; ISO 22000 cl.8.9; BRCGS Food Safety cl.3.8
Control of nonconforming outputs, of process and product nonconformities, and of non-conforming product under GFSI-benchmarked schemes.
Certification auditors sample cases and follow them outward to holds, actions and trends, so the weakest case in the period is the one that sets the finding.
How to complete it
How to complete a product nonconformance report, step by step
The fields are easy to complete and the record still fails for four reasons, all of them judgements taken in the first hour by people under pressure to keep the line running.
The first question is not what is wrong but how much of it there is and where it currently sits. Last known good, whether the problem is isolated or systematic, and the physical location of affected stock decide the size of the hold. The honest answer at hour one is usually that you do not know, and the hold must cover the unknown rather than the observed, because narrowing a hold after verification is routine and recovering despatched product is not. Retain a sample and a photograph while the product still exists, because once it is scrapped the description written at speed is the only evidence left to compare the next occurrence against.
Quality decides product status; production decides production. The failure pattern is a decision taken on the floor to keep an order moving and a quality signature applied afterwards, which reads in the record exactly like a properly authorised release and is nothing of the kind. Where the departure touches a customer specification, the authority is the customer, in writing, before the product ships.
The severity fields drive who is notified and whether an investigation happens, so they have to be set on the worst credible outcome of the defect rather than on how much of it escaped. Weight, labelling, allergen and composition claims are legal requirements and score accordingly. A case where three percent was found and rejected still carries the full legality risk of the filler or coder that produced it.
New product means a new case, always: a fresh batch with the same defect gets its own identifier so the frequency is visible. Reopen only when the same product decision is being changed, for example where released product is later shown to have been unsafe. Recurrence belongs in a trend review, and using reopens to avoid raising cases is how a site produces a falling nonconformance count and a rising complaint count at the same time.
What auditors find
Most common product nonconformance report findings
Nonconformance records are the most sampled documents in any quality audit, because they lead outward to holds, investigations, actions and trends. Findings almost always concern the decision and the closure rather than the description.
| Finding | Clause | What fixes it |
|---|---|---|
| Disposition recorded with no identified authority, or signed by production only. | ISO 9001 cl.8.7.2 | Require the quality signature before the product moves, and record the authority by name and role. |
| Product released while verification was still outstanding, without documented approval. | ISO 9001 cl.8.6 | Block release until planned checks are complete, or record the concession and who granted it. |
| Product affected marked yes with no hold identifier and no product location. | ISO 9001 cl.8.7.1 | Raise the hold record first and carry its reference and the physical location into the case. |
| Extent of the nonconformance not bounded; last known good left blank on a systematic defect. | ISO 22000 cl.8.9.4 | Hold back to the last verified good check and narrow only on evidence, not on assumption. |
| Legality risk scored low on an underweight or mislabelled batch. | Weights and Measures (Packaged Goods) Regulations 2006 (GB) | Grade weight, label and composition defects as legality risks by default and escalate accordingly. |
| Despatched product identified but customer not notified and no recall consideration recorded. | Regulation (EC) 178/2002 art.19 | Record the notification decision and its rationale at the time it is taken, not retrospectively. |
| Investigation required set to no on the basis of the quantity actually affected. | ISO 9001 cl.10.2.1 | Set the threshold on potential outcome, published in the procedure, so it is not decided case by case. |
| Case closed at disposition; referenced RCA and CAPA records never raised. | ISO 9001 cl.10.2.2 | Hold closure until the referenced records exist and the action is verified as effective. |
| No sample retained and no photograph, so the defect cannot be characterised later. | ISO 9001 cl.7.5.3 | Make sample retention the default on any case with safety, legality or customer impact. |
| Defect categories inconsistent or inherited from another form, so trend analysis is meaningless. | ISO 9001 cl.9.1.3 | Set the category list to your actual defect taxonomy and reclassify the open period before reporting. |
Case in point
Case in point: three percent, caught, closed
A dairy site found underweight tubs on a final weight check. Roughly three percent of the batch was below the declared quantity, the pallet was sorted on the line, and the case recorded quantity nonconforming, percent affected and a disposition of sorted and released. Food safety risk was scored none, legality risk low on the reasoning that the underweight units had been removed, and investigation required was set to no. The case closed the same shift with both signatures in place.
Six weeks later a customer's own quantity audit rejected a delivery from the same filler. The filler head had been drifting across a shift as product temperature rose, so failures clustered late in each run, which a single end-of-run check was well placed to miss. Four earlier cases existed on the same product, each closed at disposition and each classified under a different defect category, so no trend report had ever grouped them.
The sorting was correct and the record was complete. What was wrong was the grading: an underweight batch is a legality matter regardless of how much was intercepted, and the quantity caught measured the check rather than the process. The fix was not a better form but two rules: legality risk is set by the defect type, not the escape rate, and the investigation threshold is published in the procedure so nobody sets it at the end of a shift.
The template
The template, field by field
The form exactly as it installs. Every field, option, score and conditional rule is editable, and the links to other templates come with it.
5 sections
- Reference
- QUA-001
- Archetype
- Record
- Record ID
- CASE-2026-000
- Scoring
- Severity band
- Direction
- High is bad
- Singleton
- No
- Basis
- ISO 9001 cl.8.7
- Links
- Feeds RCA, CAPA, Hold and Release
- Tags
- Quality, Nonconformance
- Sections
- 5
- Fields
- 48
- Follow up fields
- 11
- Repeating sections
- 0
- Links out
- 6
Header
12 fieldsCase ID*
Auto sequence. Format CASE-2026-00000.
The record's own ID. Other templates point at this value.
Status*
Drives who this goes to next.
- Planned2 pts
- In progress2 pts
- Complete3 pts
- Deferred0 pts
- Open0 pts
- Closed3 pts
- Overdue0 pts
Date and Time*
Raised By*
Site*
Site ID*
Format SITE-000.
Links to FDN-001 Site ID
Line*
Shift*
Line Lead
Batch Number*
Numeric key joining to your ERP batch record.
Links to External system reference
Product*
Production Date*
The nonconformance
9 fieldsWhat Is Wrong*
Describe the deviation from specification, factually.
Specification Reference*
Actual Result*
Specification Document
Document ID
Format DOC-0000.
Links to FDN-008 Document ID
Defect Category*
Detected At*
Earlier detection is cheaper. In process beats final beats customer.
- Goods in4 pts
- In process3 pts
- Final inspection2 pts
- Warehouse1 pt
- Customer0 pts
- Consumer0 pts
Photograph
Sample Retained*
- Yes3 pts
- No0 pts
Extent
9 fieldsQuantity Nonconforming*
Quantity In Batch*
Percent Affected*
Isolated Or Systematic*
- Isolated to one unit3 pts
- Limited to part of the batch2 pts
- Whole batch1 pt
- Multiple batches0 pts
Back To Last Known Good
How far back product must be held.
Product Affected*
- No3 pts
- Yes0 pts
Quantity Affected
Hold ID
Raise the hold record, then enter its reference.
Links to QUA-003 Hold ID
Product Location
Where the affected product physically is right now.
Food safety and regulatory
7 fieldsFood Safety Risk*
- None4 pts
- Low3 pts
- Medium1 pt
- High0 pts
Legality Risk*
Weight, labelling and composition claims are legal requirements, not quality preferences.
- None4 pts
- Low3 pts
- Medium1 pt
- High0 pts
Customer Specification Breach*
- No3 pts
- Minor1 pt
- Significant0 pts
Product Already Despatched*
- No3 pts
- Yes0 pts
Recall Consideration Required
- No3 pts
- Yes0 pts
Recall Plan ID
Links to QUA-055 Plan ID
Customer Notified
Investigation and closure
11 fieldsInvestigation Required*
Set by potential outcome, not by what actually happened.
- No3 pts
- Yes0 pts
Investigation Level
RCA ID
Format RCA-2026-00000.
Links to FDN-013 RCA ID
Action Required*
Raise the action record, then enter its reference here.
- No2 pts
- Yes0 pts
Priority
- High0 pts
- Medium1 pt
- Low3 pts
CAPA ID
Format CAPA-2026-00000.
Links to FDN-014 CAPA ID
Action Owner
Quality*
Signature*
Production*
Second Signature*
QUA-001 · record IDs look like CASE-2026-000 · Feeds RCA, CAPA, Hold and Release
Open in KnowellaRun it with agents
From a document you fill in to a programme that runs itself
The form is rarely the problem. What fails is the surroundings: the hold that exists on paper but not in the stock system, the despatched pallet nobody traced, the CAPA that closed without verification, and five cases that never met each other in a report.
Holds the case log against products, lines and specifications, enforces the disposition authority before status changes, and keeps closure blocked until the referenced investigation and action records exist.
Ties the hold to actual stock and location, identifies what has already been despatched and to whom, and gives the recall question a real distribution list rather than an estimate.
Connects cases to the equipment that produced them, so a drifting filler, coder or detector accumulates a history against the asset instead of against six unrelated batches.
Groups open and closed cases by product, line, shift and defect type, surfaces the recurrence a single record cannot show, and holds every write for approval before it touches a case.
This template lives in KnowQuality — quality and food safety. HACCP, nonconformance, traceability, laboratory and customer complaints.
Meet KnowQuality→Glossary
Product Nonconformance Report definitions and key terms
- Nonconformance
- Non-fulfilment of a requirement, whether that requirement comes from a specification, a customer, a standard or law.
- Disposition
- The decision on what happens to nonconforming product: scrap, rework, regrade, return, use as is under concession, or release after evaluation.
- Concession
- Permission to use or release product that does not meet requirements, granted by the authority that owns the requirement, which for a customer specification means the customer.
- Correction and corrective action
- A correction deals with the product in front of you; a corrective action removes the cause. A case needs the first and often the second, and they are not interchangeable.
- Hold or quarantine
- Positive control of suspect product so it cannot be used or despatched, evidenced by physical identification and a system status, not an instruction.
- Last known good
- The most recent verified conforming check, which sets the point back to which product must be held when the failure was not observed at its start.
- Potentially unsafe product
- Product that may not meet food safety requirements and must be held until evaluated, released only on evidence that the hazard is at an acceptable level.
- Average quantity system
- The packaged goods rules under which mean contents must meet the declared quantity and individual units stay within tolerable negative errors, making weight a legal parameter.
FAQ
Frequently asked questions about product nonconformance report
Should the person who finds the problem raise the record, or quality?+
Whoever found it, immediately. Routing discovery through quality adds delay at exactly the point where product is still moving, and it filters out the cases someone judges not worth reporting. Quality owns the disposition and the grading, not the discovery. A record raised roughly and corrected within the hour beats an accurate one raised at the end of the shift.
Do we need a separate hold record as well as this one?+
With. The case is the decision trail for one product problem; the hold is physical control of stock, with its own release step, signatures and often its own stock status in the ERP. Merging them makes releasing product and closing the investigation one act, which is the shortcut that produces cases with no cause work in them.
Do we reopen the case or raise a new one when the same defect recurs?+
Raise a new one. The case identifies a unit of product, so a new batch means a new case even where the mechanism is obviously identical. Reopen only when the decision about the original product changes. Sites that reopen for recurrence end up with a small number of long-running cases, a falling nonconformance count and no way to show frequency to a customer or an auditor.
Does every nonconformance need a root cause analysis?+
No, and pretending otherwise produces five-why forms filled in to satisfy the workflow. What matters is that the threshold sits in the procedure and is set by potential food safety, legality and customer impact, so the rule decides rather than whoever is closing records that afternoon. Repeat occurrences should escalate the level automatically.
Can production release held product if quality is not on site?+
No. Assign quality authority to a named deputy across every shift instead, because the alternative is not that product stays held, it is that product moves without a decision and the record is written to fit. If night shift routinely has no quality cover, that is a resourcing finding waiting to be made, not a reason to widen who can release.
How does this record relate to a customer complaint about the same batch?+
The complaint record captures what the customer said and the response owed to them; this case captures the product and the decision. When a complaint is traced to a batch, raise the product case for the remaining stock and cross-reference both. Answering the complaint without holding the rest of the batch is the failure that turns one complaint into several.
Keep going
Related templates and programmes
Industries this is written for
Programmes this belongs to
Used together in HACCP and Food Safety
Unannounced Audit Readiness Check
Checks whether the site would pass an audit arriving today, covering records, standards and area condition
Hold and Release Record
Places suspect product on hold and records the decision to release, rework or scrap it
HACCP Plan
The hazard analysis and critical control point plan for a product or process
HACCP Verification Record
Confirms the HACCP plan is being followed and still works
CCP Monitoring Log
Records readings at a critical control point, such as cook temperature, chill time or metal detection
Prerequisite Programme Plan
Sets out the basic conditions that must be in place for HACCP to work, covering hygiene, maintenance, pest control and training
More in Nonconformance
Process Deviation Report
Records a process that ran outside its set limits, even where the product still passed
Hold and Release Record
Places suspect product on hold and records the decision to release, rework or scrap it
Rework Authorization
Authorises rework on nonconforming product and sets out exactly what will be done
Scrap Record
Records product written off, with quantity, reason and cost
Concession Request
Requests permission to use or ship product that does not fully meet specification
Material Rejection Report
Rejects incoming material that fails inspection
Written and reviewed by
Siddarth Singh
Founder & Chief Executive Officer, Knowella
Certified Safety Professional and industrial and systems engineer with more than a decade inside food supply chain, freight and manufacturing operations. This page was written against the current text of the standards it cites, not against secondary summaries of them.
- Certified Safety Professional (CSP), Board of Certified Safety Professionals
- MBA, University of Chicago Booth School of Business
- MS and BS, The Ohio State University, Industrial and Systems Engineering
- Six Sigma Black Belt
Sources and last review. Reviewed 16 August 2026 against:
- ISO 9001:2015 clauses 8.5.2, 8.6, 8.7 and 10.2
- ISO 22000:2018 clause 8.9, control of product and process nonconformities
- BRCGS Food Safety clause 3.8, control of non-conforming product, with the withdrawal and recall requirements
- 21 CFR 117.150 and 117.190, corrective actions, corrections and records (US)
- 9 CFR 417.3, corrective actions for FSIS-regulated establishments (US)
- Regulation (EC) 178/2002 articles 14, 18 and 19, food safety, traceability and withdrawal
- Weights and Measures (Packaged Goods) Regulations 2006 and the average quantity system (GB)
This page is general guidance, not legal advice. Confirm requirements with your jurisdiction’s regulator.