04 May Maintaining Compliance in the Fire Industry
For manufacturers of fire safety products and systems, reflects Len Swantek, FP Auditor with Victaulic, the initial design qualification and agency certifications are only the beginning of a long-term commitment to compliance, quality and consistency.
Managing Change
Throughout the product life-cycle, manufacturers may need to implement changes in any number of the areas related to product design, materials of construction as well as manufacturing and supplier processes to remain both competitive and compliant. Simple changes such as a product marking can impact the manufacturer’s ability to maintain production and distribution while the certification body evaluates the revised marking and method of application.
On a more complex scale, a manufacturer may need to provide multiple configurations of a single model that involve differing materials, wiring configurations, pressure ratings and packaging to meet customer demands concurrently in a range of markets or geographic regions. In this case, a more detailed examination will be conducted by the certification body. When critical components are involved, additional performance testing and qualification will be undertaken to ensure all configurations will comply with the governing standards. When the testing and requalification is successfully completed, the audit programmes will resume on their prescribed schedules.
Suppliers or their sub-contractors who implement process or material changes must also be surveyed if they are supplying an agency-certified component or assembly. These types of changes can be more challenging to manage when sub-contractors are not fully aware of the regulations and governing standards. An example of this involves the application of the “CE” mark in accordance with the Construction Products Regulation (CPR). While the OEM producer often has sole responsibility for the design, materials and rated performance of the final product, their ability to track supplier changes is also critically important. These records will be examined as part of the auditor’s survey, and in some cases, an additional review at the supplier’s location may also be warranted.
Additionally, if the manufacturer establishes regional production sites, each of these will be individually audited for product consistency. It is therefore to the manufacturer’s advantage to utilise a single quality system and internal process control procedures, as well as replicated manufacturing methods at all production locations. This makes the audit process much easier to manage for both the manufacturer and the auditor.
Making the Grade
While manufacturers strive for the highest quality products that utilise optimal production systems and process controls, occasionally an audit may result in a less than perfect report of compliance with the certification body’s requirements. From time to time, auditors may find non-conformances (NC’s) by way of the in-depth survey of the design, manufacturing and quality systems.
In the event of such findings, the manufacturer must provide clear and documented root cause analysis, as well as a detailed plan for corrective action moving forward. The internal study may involve a review of both complete assemblies as well as individual components including performance tests, material property studies and production tooling reviews to validate dimensional compliance, as well as a full review of all relevant design data (drawings, formulations, standards & specifications, production controls, quality plans and procedures).
During this process, it is critically important that the manufacturer responds quickly and concisely to avoid any disruption in the supply of product to their customers. Depending on the severity of the audit finding, the producer may need to place inventory in a hold position until all aspects of the NC are fully satisfied. This type of scenario can have far reaching implications involving the disposition of finished goods; ex. rework, discarding of material, and restarting / requalifying the manufacturing process including the retesting of product before the material is released for sale and distribution.
Clear communication with all stakeholders and resources is vitally important to ensure the proposed corrective actions are checked for technical and manufacturing feasibility, while also maintaining previously established commercial and market objectives. While the certification body and their auditors are checking for compliance to the governing standards, other factors such as cultural differences, interpretation of requirements or general unfamiliarity with the relevant process / technology can delay the final resolution and acceptance of the corrective action plan.