Cetec ERP enables businesses to compete effectively in regulated markets (e.g. Medical, Military, and Aerospace) with strict customer and certification requirements (e.g. ISO 9001, ISO 13485, AS9100, API Spec Q1/Q1, FDA requirements, UL, etc.) The system builds in automated quality tools so you can meet requirements more efficiently and at lower costs than your competitors.
Military and medical customers must be able to trace back through the supply chain for all parts and components in an end product. Cetec ERP’s inventory management platform offers intelligent, system-dictated processes to ensure complete component traceability. We implement a FIFO inventory methodology with bin level routing to guide warehouse users to parts and barcode / iPad support to facilitate the put-away and pick parts processes. The pick-parts process simultaneously relieves inventory and captures date-code / lot-code data for the particular order, achieving total traceability for your customer purchase orders.
Medical customers often require the collection of data (i.e. user initials, component measurements, etc.) in and throughout various steps of a build or inspection. This represents an overwhelming process enforcement and document management challenge to many businesses.
To address this need, Cetec ERP wraps data collection into the paperless work instructions delivered to production users during the build or inspection process. In addition to simultaneously delivering and capturing build data, Cetec ERP allows you to enforce process control and require data entry at certain build steps before the part can leave the station, let alone before it can ship to a customer.
ISO auditors will look for an ability to demonstrate a systematic approach to both preventing and resolving issues when they occur. In general, this will require a defined set of processes and responsibilities for executing the quality system across your business. Cetec ERP contains a robust set of features to help you meet ISO requirements and minimize the volume of time, cost, and paper required to prepare for audits and execute an effective quality system.
Auditors will pay close attention to your company’s ability to manage and respond to product failures and customer complaints in a systematic way. At Cetec ERP configuration, we’ll work with you to define a work-flow to route all customer complaints, satisfaction cases, inspection failures, and non-conformance reports to the appropriate departments and personnel. The ability to demonstrate a consistent, system-dictated process for all product issues that arise is crucial for ISO audits and certifications.
Corrective Action / Problem Prevention
Cetec ERP includes a range of corrective actions to employ should they become necessary for certain products or customers. These quality tools will not only impress your ISO auditors, but also enable you to earn back the trust of customers who may have been affected by faulty parts or products.
The following is a list of corrective and preventative actions Cetec ERP unlocks for your company:
Build Process Control - customizable work instructions provide the ability to require extra steps, data entry, or management approval before a part can move forward to the next location in the system.
Quality Alerts - virtually post quality alerts to BOMs on a per part basis to notify anyone on the shop floor who touches the part in question. For any work order with that part, the system automatically publishes the alert in bright red lettering with a link to the document or image explaining the quality issue at hand.
Kit Audits - for orders with parts susceptible to failure, you may require a certain percentage of kits to audit and inspect before they hit the shop floor. Then, if your corrective actions begin to produce higher and higher pass rates at inspection, lower the kit audit percentage to reflect the enhancement in quality.
Cetec ERP includes fields relevant to the particular data your company requires for inspections. The system collects the inspection data you enter to drive quality reports, inspection reports, yield rates, on-time yield rates, and other quality related reports. When the time comes to begin preparation for an audit, your inspection data is already aggregated and ready to be pulled into a report - just search across the relevant dates and orders to pull in data you’d like to present to the auditor. Utilizing the Cetec ERP system in this way can remove an enormous burden of time typically used preparing for audits.
ISO certification bodies require that all tools must be calibrated and maintained on a regular schedule per their specific engineering requirements. Cetec ERP employs an intelligent tooling maintenance feature to automate the scheduling and logging of equipment maintenance. Search across relevant dates, in the past or future, to pull information on the current status of all tools in your plant.