Operational data management runs on the Company Workspace. It opens together with the Company Workspace. How the storage is protected and managed is described in the Information Security Guide.
Operational data management: the same operation method for all Economic Prosperity standards

The same operation method is used for ISO 9001, IATF 16949, ISO 13485, ISO 19443, ISO 22000 and ISO 21001. Based on a product or project, you register a control plan and QC process chart (a HACCP plan for food, an education course operation plan for educational organizations) and set the control items and specifications (lower limit, target, upper limit) for each process step. Records from raw material input to shipment are kept in structured numeric form, so they can be used directly for AI analysis such as trends, anomaly detection and cause analysis.

Based on ISO 9001What you do on this screenNext steps
8.1 Operational planning and controlRegister control plans and QC process charts, define process steps and control items, version controlProcess Control
8.2 Requirements for products and servicesRecord customer requirements (linked to contracts)Contract Management
8.3 Design and developmentRecord design and development outputsDesign and Development Control
8.4 Control of externally provided processes, products and servicesIncoming inspection recordsSupplier Management
8.5 Production and service provisionProcess records and in-process inspection records, lot traceabilityProcess Control
8.6 Release of products and servicesFinal inspection and shipment approvalProcess Control
8.7 Control of nonconforming outputsPass rejected records on as nonconforming productsNonconforming Product Control

The clauses that serve as the basis for the other standards (IATF 16949 control plan 8.5.1.1, ISO 13485 chapter 7 product realization, ISO 22000 8.5.4 hazard control plan and 8.9 nonconformity, ISO 21001 educational products and services, ISO 19443 requirements for the nuclear sector) are shown together on the control plan screen for each operating standard of the product.

What you can use now: Registering products, projects and measuring equipment; control plans and QC process charts (process steps, control items, specifications, preparation, review and approval, versions); viewing change history; entering records by record category (from customer requirements to shipment, with lot, measured values, automatic judgment and shipment approval); tracing up and down from contract to shipment with the contract register and lot genealogy (receipt, production, shipment); passing rejected records on to 15 Nonconforming Product Control (handling, approval, re-verification, closure). Analysis and evaluation of operational data: choose from 16 statistical techniques (descriptive statistics, normality test, process capability indices Cp, Cpk, Pp and Ppk, X̄-R, X̄-s, Me-R and X-Rs control charts, p, np, c and u control charts, Pareto and trend, stratified comparison and analysis of variance, correlation analysis and regression analysis) and analyze data by product, process, control item and period, and export measured values as CSV or TSV. Customer claim and complaint register: receive claims, complaints and field failures and record them through investigation, reply and closure (linked to contracts, lots and nonconforming products), analyze type, cause and cost with Pareto, trend and c control charts, and print the reply letter. 8D reports (D0 to D8, starting from a claim or nonconforming product, preparation, review and approval, printing) and customer satisfaction survey results (item scores, overall %, targets, voice of the customer, trend, stratified comparison and Pareto) are also managed together in the Customer response tab.
Principles we keep: Names of products, customers and items, and remarks, are encrypted with a different key for each company, while numbers, measured values, judgments and dates and times are kept as numbers and text so that they can be analyzed. Changes are kept together with the values before and after and who changed them and when, and items an administrator can restore (products, equipment, records) can be restored within the retention period (3 years by default) after deletion. An approved control plan is not edited but replaced with a new version. AGENT does not view the content and does not use it for certification audits. Decisions (review and approval) are made by your company.

My operational data

Loading…