CEPROCON.COM • BLOG ARTICLE • WEEK 12
The internal quality system every CE marked construction product manufacturer must operate
Factory production control CE marking requirements are among the most frequently misunderstood aspects of CPR compliance. Factory Production Control — FPC — is one of the most frequently misunderstood requirements of CE marking for construction products. Many manufacturers have heard of it, know it is required, and have some form of documentation in place. Far fewer have a system that genuinely functions as the Construction Products Regulation (CPR) intends.
The gap between having an FPC system and having one that works is significant — and consequential. Under AVCP systems 1+, 1, and 2+, a Notified Body will audit the FPC system before issuing its certificate and will return annually to check it is still functioning. A system that looks good on paper but does not reflect production reality will not survive that scrutiny.
This article explains what FPC is, what it must contain, how it relates to CE marking under different AVCP systems, and how to build a system that works in practice — not just on paper.
What is Factory Production Control?
Factory Production Control is the manufacturer’s internal system for ensuring that construction products are manufactured consistently and in conformity with the product type that was assessed during type testing. It is the mechanism by which the manufacturer maintains, and can demonstrate, that every unit leaving the factory performs as declared in the Declaration of Performance (DoP).
The CPR does not define FPC in exhaustive detail — instead, it delegates the specific requirements to the applicable harmonised standard. Each harmonised standard includes FPC requirements tailored to the product type it covers, typically in a dedicated clause and referenced in Annex ZA. These requirements vary between product categories, but the underlying principle is consistent: the manufacturer must have documented procedures, carry out inspections and tests at defined stages of production, and keep records that demonstrate the system is operating.
FPC is required under every AVCP system — including system 4, where no Notified Body is involved. Even when the manufacturer self-declares everything, they must still operate a documented FPC system.
FPC and AVCP systems — what changes?
The AVCP system assigned to a product determines not just who conducts type testing, but also the level of third-party involvement in the FPC system. Understanding this relationship is essential before designing an FPC system:
| AVCP system | FPC requirement | Notified Body role in FPC |
|---|---|---|
| 1+ | Full FPC system required | Certifies FPC + ongoing surveillance audits + product sampling |
| 1 | Full FPC system required | Certifies FPC + ongoing surveillance audits |
| 2+ | Full FPC system required | Certifies FPC + ongoing surveillance audits (no product testing) |
| 3 | Full FPC system required | No FPC involvement — type testing only by Notified Testing Laboratory |
| 4 | Full FPC system required | No involvement |
The key point is that the FPC obligation does not disappear at system 3 or 4 — it just loses the Notified Body oversight. For systems 3 and 4, the manufacturer bears full responsibility for ensuring their FPC system is adequate and functioning. For systems 1+, 1, and 2+, the Notified Body provides external assurance through certification and audit.
What must an FPC system contain?
While the exact requirements depend on the applicable harmonised standard, every CPR-compliant FPC system must address the following areas:
1. Documentation and procedures
Written procedures for all production activities that affect the product’s performance against its essential characteristics. These procedures must describe what is done, how, by whom, and at what frequency. They must be kept up to date and must reflect what actually happens in the factory — not an idealised version of it.
The FPC documentation typically includes an FPC manual (the overarching document describing the system), work instructions (step-by-step guidance for specific tasks), and forms and records templates.
2. Incoming material controls
Controls on raw materials, components, and bought-in products that affect the finished product’s performance. This includes supplier qualification, incoming inspection procedures, acceptance criteria, and records of each incoming delivery. Where a material specification change could affect the product’s essential characteristics, the FPC system must trigger a review.
3. In-process controls
Inspections and checks carried out during the production process at defined stages — not just at the end. The harmonised standard typically specifies which process parameters must be controlled and monitored. Records of in-process checks must be retained and must be traceable to the specific production batch or lot they relate to.
4. Finished product testing and inspection
Testing or inspection of the finished product at defined frequencies, to verify that it continues to conform to the declared performance. The frequency and method of finished product testing is usually specified in the harmonised standard’s FPC requirements. Results must be recorded and compared against acceptance criteria derived from the declared performance values.
5. Equipment calibration and maintenance
All measuring, testing, and production equipment that affects product performance must be calibrated at defined intervals and maintained in proper working order. Calibration records must be kept, showing the equipment identifier, calibration date, result, and next calibration due date. Equipment that is out of calibration must be taken out of service until recalibrated.
6. Non-conformance handling
A defined process for identifying, segregating, and disposing of non-conforming products — those that do not meet the required specifications. Non-conformances must be recorded, investigated to identify root cause, and resolved through corrective action. The system must prevent non-conforming products from being placed on the market as CE marked.
7. Corrective action
Where non-conformances or other quality problems are identified, the FPC system must include a corrective action process — a structured approach to investigating the root cause, implementing a fix, and verifying that the fix has been effective. Corrective actions must be documented and tracked to closure.
8. Traceability
The ability to trace any unit of finished product back through the production records — to the batch of raw materials used, the in-process check results, the finished product test results, and the production date and conditions. Traceability is essential for effective recall management and is a standard requirement during Notified Body audits.
How to build an FPC system that actually works
Many manufacturers approach FPC as a documentation exercise — producing the required manual and procedures to satisfy an audit, rather than designing a system that genuinely supports production quality. The result is an FPC system that passes the initial audit but deteriorates in practice, with records that are incomplete, equipment that drifts out of calibration, and procedures that no longer match what actually happens on the line.
Building an FPC system that works requires a different approach — starting with production reality rather than documentation ideals:
Start with the harmonised standard’s FPC requirements
Before writing a single procedure, read the FPC requirements in the applicable harmonised standard carefully. These define the specific controls, inspection frequencies, and record types that the standard requires for your product category. The FPC system must meet these requirements as a minimum — everything else builds on them.
Map the production process first
Document the actual production process as it is, not as you wish it were. Identify every stage at which a process parameter, material characteristic, or inspection result could affect the product’s performance against its essential characteristics. These are the control points the FPC system must address.
Design for the people who will use it
FPC procedures must be written for the people who carry them out — production operators, quality inspectors, shift supervisors. Overly complex or bureaucratic procedures will not be followed consistently. Clear, concise work instructions with defined acceptance criteria and straightforward record forms are far more likely to be used correctly than lengthy technical documents.
Build in regular internal review
An FPC system is not a static document — it must evolve as the production process, equipment, materials, and personnel change. Schedule a regular internal review — at least annually — to check that procedures still reflect current practice, that records are being completed correctly, and that corrective actions from previous non-conformances have been effective. This internal review is also the best preparation for a Notified Body surveillance audit.
Link FPC to your change management process
Any change to the product, the production process, raw materials, or equipment must trigger an assessment of whether the FPC system needs to be updated. This linkage between change management and FPC is one of the areas most commonly missing in manufacturers’ systems — and one of the first things a Notified Body auditor will probe.
What Notified Body auditors look for
For manufacturers under AVCP systems 1+, 1, and 2+, the Notified Body will assess the FPC system during both the initial certification audit and subsequent surveillance visits. Understanding what auditors look for helps manufacturers prepare effectively.
Auditors typically focus on four areas:
- Completeness: Are all the FPC elements required by the harmonised standard documented and in place?
- Implementation: Is the system actually being operated as documented? Are records being completed, equipment being calibrated, and non-conformances being recorded and acted on?
- Consistency: Are products leaving the factory consistently conforming to the declared performance? Do production records and test results show a stable, controlled process?
- Responsiveness: When problems are identified — non-conformances, equipment failures, material variations — is the system responding effectively and is there evidence that corrective actions have been implemented?
A common finding during surveillance audits is that the FPC system was in good shape at the time of initial certification but has since deteriorated — records are incomplete, calibration has lapsed, or procedures have become outdated. Manufacturers who treat FPC as a continuous operational commitment rather than a one-time setup are far better placed at audit time.
FPC and the Declaration of Performance
There is a direct and important relationship between the FPC system and the Declaration of Performance. The DoP declares the performance of the product type — the product as it was assessed during type testing. The FPC system is what ensures that the products actually manufactured and placed on the market continue to match that product type.
If the FPC system breaks down — if production drifts away from the assessed product type without the change being detected and managed — then the products being sold under the CE mark may no longer correspond to the declared performance. This is the scenario that FPC is specifically designed to prevent, and it is the reason that a functioning FPC system is a legal requirement, not an optional quality initiative.
Summary
Factory Production Control is the operational backbone of CE marking for construction products. It is the system that connects type testing — a snapshot of product performance at a point in time — to the ongoing reality of production, ensuring that the products placed on the market continue to perform as declared.
Every CE marked construction product manufacturer must operate an FPC system. Under AVCP systems 1+, 1, and 2+, that system will be assessed and audited by a Notified Body. Under systems 3 and 4, the manufacturer bears sole responsibility for its adequacy.
Building an FPC system that works requires starting from the harmonised standard’s requirements, mapping actual production reality, and designing procedures that people will use consistently — not just a set of documents that looks good in a folder. For a broader understanding of how FPC fits into the complete CE marking process, see our step-by-step overview of CE marking for construction products and our guide to building your technical file.
Need help setting up or reviewing your FPC system?
CEProCon helps construction product manufacturers build FPC systems that meet harmonised standard requirements and stand up to Notified Body audit — from initial setup through to pre-audit review and ongoing maintenance support. We also cover FPC requirements in depth in our professional training programme.
contact@ceprocon.com • ceprocon.com
