Quality Management

Main Process

 

Quality Manual (ISO 9000)

Documentation of a quality system according to the ISO 9000 standard. In the automotive industry, ISO 9000 is supplemented by standards such as QS 9000 and TS 16949. In the food and drug industry, it is supplemented by so-called "Good Manufacturing Practice" and other rules (GxP). SAP ERP offers a variety of tools, such as knowledge warehouse or document management, to maintain a quality manual.

Advanced Product Quality Planning (APQP)

Segment of the QS-9000 standard, which is based on typical methods and tools for preventing defects. SAP Business Suite offers the cProjects component to support the product development process by methods such as Quality Gate and tools such as Control.

Plan and FMEA. Production Part Approval Process (PPAP)

Segment of QS 9000, which defines the generic requirements for approval of production parts. Its purpose is to determine during an actual production run at the quoted production rates whether all customer engineering design record and specification requirements are properly understood by the supplier and to determine that the process has the potential to produce product consistently meeting these requirements. Additionally, ERP offers the audit management solution, which supports process and product audits.

Failure Mode & Effects Analysis (FMEA)

A procedure in which potential failure modes of an item are analyzed to determine the risks. SAP ERP can be enriched by SAP SI to provide special FMEA solutions, which are based on the quality notification component.

Stability/Shelf-Life Study

Testing how well products will keep quality over predefined Periods of time under controlled environmental conditions. SAP ERP offers a complete set of tools for planning and performing stability studies.

Inspection Planning

Identifies the inspection characteristics and inspection methods and defines the inspection operations. SAP ERP offers advanced tools for inspection planning. Standard operation procedure management is supported. An inspection plan can be generated out of a control plan.

Specifications

A document that states the requirements to which a given product must conform. The requirements are described by quality characteristics. SAP ERP inspection plans can be used to represent specifications.

Sampling Procedure (ISO 2859, ISO 3951)

Indicates the sampling sizes and associated acceptance or rejection criteria to be used. SAP ERP supports standardized sampling systems such as ISO 2859 (attributive inspection) and ISO 3951 (variable inspection) as well as self-defined sampling procedures. Sampling plans according to ISO 2859-1 and ISO 3951 are available ready to be used. Dynamic modification of the sample size and skip lot is also supported. Modification rules according to ISO 2859-1 (normal - tightened # reduced inspection) and 2859-3 (varying skip rate) are available ready to be used.

Recipe & Trial Management

Is used in the process industry during the development process. It supports structured product specifications and recipe definition from the first product idea down to the production-line-specific level.

Document Management

Creates, maintains, and retrieves documents in a safe and secure way. For quality documents, the document management solution of SAP ERP is an optimum choice, because of it's strong integration into the supply chain master data.

Master Data & Change Management

Creates, maintains, and retrieves the master data needed for quality management. SAP ERP supports quality data, which are embedded in general master data such as material master or vendor master. Provides master data for quality inspection such as inspection method, inspection characteristic, and inspection equipment. Supports standard operation procedure management.

Supplier Management

Ensures that the products of the supplier will be fit for use with minimal corrective action and inspection. According to J. M. Juran, there are nine primary activities needed: (1) define product and program quality requirements, (2) evaluate alternative suppliers, (3) select suppliers, (4) conduct joint quality planning, (5) cooperate with the supplier during the execution of the contract, (6) obtain proof of conformance to requirements, (7) certify qualified suppliers, (8) conduct quality improvement programs as required, and (9) create and use supplier quality ratings. SAP ERP supports all of these aspects. For example, by means of a data set, which is related to vendor and material, a vendor relationship can be initiated, released, or blocked; quality agreements can be handled.

Quality Inspection

Measures, examines, tests, and gauges one or more characteristics of a product or service and compares the results with specified requirements to determine whether conformity is achieved for each characteristic. Includes inspection lots of various origins. Provides results recording and defects recording and mobile and Web recording. Includes usage decision and release of the stock from being in quality inspection. Follow-up actions include batch classification and dynamic modification. With an Internet transaction server, the customer can provide the vendor with an HTML entry screen on the Internet. The vendor then records and saves the inspection results on the Web. The results are transferred directly to SAP.

Inspection Equipment Interfacing

SAP ERP offers a standardized interface for connecting measuring subsystems and for external control of inspection operations on shop floor level.

Statistical Process Control (SPC)

Is the application of statistical techniques to control a process. The term statistical quality control is often used interchangeably with statistical process control . SAP ERP supports standard Six Sigma (6s) approaches for analyzing measured values and nonconformance data, e.g., various quality control charts, Western Electric rules, capability indicators cp and cpk, Pareto analysis, trend analysis, and exception analysis. It provides an interface (QM-STI) to external tools for statistical analysis, for example, if you need verification of a distribution or significance tests.

Laboratory Information Management (LIMS)

Facilitates the testing of samples that routinely pass through an analytical lab. Manages the complete routine from sample log-in and testing until final reporting. Organizes the inspection results into specific report formats to meet regulatory requirements. SAP ERP includes an application for quality management, which can functionally compete with best-of-breed LIMS. Supporting the trend of shifting from isolated data islands to global information platforms, this Enterprise LIM reaches far beyond the borders of traditional LIMS. Because of its tight integration in the supply chain components of the ERP system, it can offer functions for inventory control and batch tracking as well as problem handling and management of corrective actions.

GxP Compliance

Acronym for Good Clinical/Laboratory/Manufacturing Practice (GCP, GLP, GMP). Includes guidelines for enterprises that are regulated by the Federal Drug Administration (FDA). SAP ERP provides all the functions that are necessary to fulfill such requirements. For example, it supports FDA document control (corresponding to 21 CFR Part 11), digital signature, audit trail, batch traceability, and electronic batch record (EBR). SAP's development and service organizations are certified according to ISO 9000.

Sample Management

Allows you to plan and automatically generate samples (physical samples, pooled samples, and/or reserve samples) at goods receipt or in production. You can create individual sample master records for all kinds of sample types, for example, goods receipt samples, environmental samples, and competitor samples.

Batch Management and Traceability

Are required if products may vary in quality or if they originate from different production runs. SAP ERP can provide identification, classification, and inventory management for different batches of a material. Bottom-up as well as top-down analyses are offered in order to show into which final products a batch of raw material has flown or which batches of raw materials have flown into a final product. It might even be necessary to show the life cycle of individual items. In this case, traceability is achieved via serial numbers. Moreover, process data can be stored in an order record and in an optical archive (electronic batch record).

Certificate of Analysis

Is related to a lot or batch, in order to document that it meets the quality requirements. SAP ERP supports the creation of all types of certificates that may be sent to customers, e.g., as suggested by European standard EN 10204. Form, contents, recipients, language, and the delivery form of a certificate are automatically selected depending on material, customer, or other criteria. Outgoing certificates are usually created at delivery time. Structured and textual certificate data can be transmitted to the recipient via a quality data interchange (QDI). SAP ERP also supports the management of incoming certificates, which are delivered together with supplied material. Certificate data that is received via QDI can be recorded automatically as inspection results. Quality certificates for delivery or batches enable customers to obtain a quality certificate over the Internet for goods delivered. The customer can either retrieve a certificate that is created instantly or access one that is stored using ArchiveLink. Exchanging quality certificate data offers easy access to the quality data in certificates. You can send the certificate to the target system in electronic form. If the quality certificate relates to a delivery to the customer, the inspection results on the certificate can be automatically transferred to a goods receipt inspection lot or manually to another inspection lot type. A quality certificate can be processed flexibly in the recipient's system. It can either be sent in reference to a customer delivery, a particular inspection lot, or a batch.

Gage Calibration (ISO 10012)

Includes the comparison of a measurement instrument of unverified accuracy to a standard instrument of known accuracy to detect any deviation from the accuracy specification. SAP ERP supports the complete calibration process, especially the calibration inspection, in accordance with ISO 10012 and other standards. It supports the generation of equipment calibration orders on a regular basis, it provides the calibration instruction, it enables results recording, and it can adjust the status of the equipment depending on the inspection result.

Quality Costs

Includes the cost associated with inspecting a product to ensure it meets the internal or external customer's needs and requirements; this is an appraisal cost. Includes the costs associated with providing poor quality products or services. There are four categories of costs: internal failure costs (costs associated with defects found before the customer receives the product or service), external failure costs (costs associated with defects found after the customer receives the product or service), appraisal costs (costs incurred to determine the degree of conformance to quality requirements), and prevention costs (costs incurred to keep failure and appraisal costs to a minimum).

Problem/Complaint Management

Provides the notification and analysis of nonconformities, defects, and failures that are related to products, processes, or services. SAP ERP supports problem management with its quality notification tool. Via the Internet service request, it is possible to record quality notifications using variable templates depending on the scenario. Notifications are a flexible tool for recording, processing, and monitoring all unplanned events in an organization.

In t he request to deviate from specification scenario, you can contact a business partner to request permission to deviate from the specification. For example, if a vendor part does not meet your specifications, you can document this fact as a defect in a quality notification. During notification processing, you can request permission from an internal or external notification partner to use the same vendor part in production.

Corrective and Preventive Action (CAPA)

Includes the implementation of solutions resulting in the elimination of an identified problem and all activities taken to improve a process to prevent future occurrences. SAP ERP quality notification supports the necessary corrective action. Corrective measures can be related to the problem in general and to individual nonconformities. A complete 8D process can be performed out of a quality notification. Extensive 8D processes, which take on the habit of a corrective project, can be supported by the cProjects component of SAP Business Suite.

Solution Database

Contains information to describe an action or process that is intended to eliminate a symptom and the problem indicated by the symptom. Its design allows you to define a solution using various information sources (e.g., free-text description, basic data and classification, actions that must be performed, attachments, or linked symptoms).

Quality Information Management

Includes vendor evaluation Balanced Scorecard Web reporting using SAP Business Information Warehouse.

An audit is a systematic examination used to determine to what extend an object meets previously specified criteria. Audits are usually performed using question lists which represent the criteria. Audit management means to plan and process audits, grade the audit objects, monitor corrective and preventive actions that were based on the findings, and analyse audit data. The Audit Management software is very versatile can support all appraisals (examinations, inspections, checks, revisions) that are performed on the basis of previously specified criteria. Examples of usages are:

• Quality Management (system audit, process audit, product audit), Good Manufacturing Practises
• Environment Management, Hygiene Management
• Safety & Security Management (facility safety, fire safety, data protection)
• Financial Revision, Risk Management