CAPA I have extensive experience in implementing CAPA (Corrective Action Preventive Action) solutions using SAP Quality Notifications.

I am one of the few SAP QM Consultants that has a history of implementing the full Quality Notification functionality. There are many existing SAP sites that are doing Defects Recording but only a few that are really using the full closed loop functionality (Defect Locations, Tasks, Causes and Activities). The key to the Quality Notifications are to correct processes that are out of control or are trending in that direction. When companies only use the Defect portion they can only do defect reporting which might look good for meetings and graphs but it does nothing to ensure the defects/issues do not occur again. So in most cases the sites are entering defects in SAP but are also still using the manual or non integrated corrective action systems. So they never really reap the full benefits of SAP Quality Notifications. The actual CAPA processes are in most cases complex, involving many people. Their current processes involve a lot of e-mails and phone calls to try to ensure the processes are followed through. But these types of systems inherently are flawed with a lot of loose ends that do not get filled. Consequently the same types of defects/issues reoccur because of poor follow through. When using the full SAP QM Quality Notification functionality you can ensure the notification is not closed out until all the corrective actions have been performed and the approvers are satisfied with the results. Also, all the processes are tightly integrated with the rest of the SAP system. For example, if a defect is recorded against a material received from a vendor then the notification has the key purchase order information linked to the notification. Following is an example of a full QM Quality Notification lifecycle: 1. Defect is identified, can come from various sources:

Customer Complaints Internal Unplanned Deviations External Unplanned Deviations Customer Audits Vendor Audits Internal Audits Annual Product Reviews Quality Out of Specifications Trending Analysis

2. User enters the defect information into SAP Quality Notification summary screen. The end user needs to provide the details of the incident. 3. Notification Coordinator is monitoring existing and new notifications, they see the new notification 4. Notification Coordinator does an immediate assessment to determine what type of action needs to be taken. Also, they fill out more of the notification from the entered summary information: a. Priority b. Defect Codes c. Defect Location Codes d. Contact Persons 5. If the defect requires corrective action then the Notification Coordinator assigns Tasks to applicable departments that need to investigate. These tasks will have due dates which will help the departments manage their work load. 6. The departments are running the Notification Tasks Work List periodically throughout the day. When they find a new task they set its status to In Process and assign it to a person. 7. As each task is complete the department will enter what they found during their investigation into long text and set the task User Status to Complete. 8. The Notification Coordinator is monitoring tasks that are complete. When they pick up the task they will look for completeness, if it is not complete they will set the User Status to Rework and push it back to the department. If it is complete they will set the task System Status to Complete. 9. The Notification Coordinator reads the long text and extracts the Root Cause information. Also, the Activities that were performed to correct the process are identified. This information is translated into Catalog Codes so the information can be reported against for trending analysis. 10.If the immediate problem has been fixed but their needs to be a long term investigation, the Notification Coordinator can open up a Long Term Notification that is linked to the initial notification. This allows the initial notification to be closed but the Long Term can now be managed separately, which may involve a different group. 11.When all the tasks for a notification have been completed and the Notification Coordinator is satisfied, the coordinator will send a Task to the Approver for final review and closure. 12.The Approver periodically through the day runs the Task Work List to see if there are new task for notification review. When satisfied they will set the notification to Closed. This is just one example of a full SAP Quality Notification lifecycle. SAP Quality Notifications has a lot of flexibility to meet various business models. In

most cases it is the Change Management piece that is the hardest part of the implementation, not the SAP notification functionality. Because CAPA systems touch so many people and business scenarios within a company it is a big stretch to get them to all commit to the new processes. So we manage early on the Change Management portion to ensure everyone is on board and the proper amount of training has been planned for. It is crucial to have the right person on board to design and implement SAP Quality Notifications to meet the business requirements and to ensure successful project lifecycle management.

Implementing CAPA with SAP Notification

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Tuesday, April 27, 2010

Implementing CAPA with SAP Notification
Managing Material and Process Non Conformances and Follow up Corrective and Preventive Action (CAPA) is the core of Sound Quality Management System and is Central to Close Loop, Contineous Improvement Process. Traditionally, Homegrown Sytems, Stand-alone Applications, or Even Manual Paper Based Systems have Managed the Process at Departmental Level to Serve the Need of Specific User Groups. Such Solutions Fail to Address Quality Problems because they lack Broad Enterprise Reach.

Companies are now Recognizing Significant Impact of Quality Control on Profitability and taking an Enterprise-wide Approach to Automating Non-Conformances and CAPA Management. SAP Notification Provides a Comprehensive Non-Conformance and CAPA Solution that enables Companies to Streamline there CAPA and NC Management Proces across the Enterprise. The key to Quality Management is to Correct the Processes which are out of control or are Trending in that Direction. When Companies Only use the Defect Portion they can only do Defect Reporting which might look good for Meeting and Graphs but does nothing to ensure the Defects/Issues do not occur again. So in most cases SAP users entering defects in SAP but are aslo still using the manual or non Integrates Corrective Action System. So they never really Reap the full benefits of SAP Quality Notifications. The Actual CAPA Process are in the most cases Complex, Involving many People. Their current Processes involve lot of E-mails and Phone calls to try to ensure that Processes are followed Through.But These Type of Systems Inherently are flawed with lot of Loose ends that do not get filled. Consequently same type of issues/defcts reoccur because of poor follow through. When using Full SAP Quality Notification Functionality you can ensure the Notification is not closed out until all Corrective Action have been performed and the approvers are stisfied with results. Aslo, all the processes are tightly integrated with rest of the SAP System. For example, if Defect is Recorded against material Received from Vendor then Notification has key Purchase Order Information linked to the Notification. Following is an exaple of Full QM Notification Lifecycle. 1. Defect is identified, can come from various Saources. 2. User Enters Defect Information into SAP Quality Notification Summary Screen. 3. Notification Co-ordinator is Monitoring Existing and New Notifications, they see the new Notification. 4. Notification Co-ordinator does an immediate assessment to determine what type of action needs to be taken. Also, they fill out more of Notification from entered Summary Data. Priority, Defect Codes, Defect Location Codes, Contact Persons, Department Responsible.

5. If Defect Requires Corrective Action then Coordinator assigns Tasks to applicable department that needs to be investigate. This Task will have due Dates which will help Departments to manage their Work load. 6. Departments are Running Notification Tasks work list Periodically Throughout the day. When they find new task they set Status as 'In Process' and assign it to person. 7. As each task is complete the Department will enter what they found during their investigation into long text and set the tasl user status to Complete. 8. The Notification Coordinator is monitoring Tasks that are Complete. When they pick up the task they will look for completeness, if it is not complete they will set User Status to "Rework" and Push it back to Department. If it is Complete they will set System Status of Task to "Complete". 9. The Notification Coordinator Reads the Long Text and extracts the Root Cause Information. Also the Activities that are performed to correct process are identified. This information is translated into Catalog Codes so that Information can be Reported against for Trending Analysis. 10. If immediate Problem has been fixed but there needs to be long term Investigation, the Coordinator can open up long term notification that is linked to the initial Notification. This allows intial notification to be closed but long term can be managed separately, Which Involves different Group. 11. When all the tasks for a Notification have been Completed and Notification Coordinator is satisfied, the coordinator will send task to the Approver for final review and Closure. 12. The Approver Periodically Through the day Runs the task work list to see if there are new task for notification Review. When Satisfied they will set Notification to "Closed".

This is Just and Example of Quality Notification Lifecycle. SAP Quality Notification has a lot of Flexibility to meet Various Business Models.

Posted by harish at 9:48 PM 0 comments Labels: CAPA, CAPA Management, Quality Notifiaction, SAP Notification

Inspection Planning Identifies the inspection characteristics (tests) and inspection methods (procedures) and assigns it to various inspection operations of an inspections plan or material specification. SAP ERP offers advanced tools for inspection planning and the management of standard operation procedures. This includes the planning of multiple specifications for one inspection characteristic dependent on defined criteria, e.g. country, customer, or legal tolerances. Advanced Product Quality Planning (APQP) Segment of the QS 9000 standard, which describes an approach to product development in the discrete industry and is based on typical methods and tools for preventing defects. SAP Business Suite offers the cProjects component to support the phase-based product development process (Quality Gates). Failure Mode & Effects Analysis (FMEA) A procedure in which potential failure modes of an item are analyzed to determine the risks. FMEA can be used for root cause analysis in Six Sigma projects, risk assessment during product development and operational quality control and planning. FMEA supports compliance with ISO TS16949 (automotive industry). Control Plan The intent of a process control plan is to control the product characteristics and the associated proces variables to ensure capability (around the identified target or nominal) and stability of the product over time. The control plan in SAP ERP enables you to plan and visualize all relevant inspections for the final product and all its components. In addition, it connects all information from related objects. FMEA and control plan are processes intended to support a "closed loop inspection planning" as it is requested in the international standard ISO / TS 16949, which is especially important in the discrete industry. 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. 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 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 its 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 test equipment. Engineering change management is provided for these master data. 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 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 ISO 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. This process is supported by the following SAP and/or partner offerings SAP ERP Quality Assurance / Control Quality Inspection Measures, examines, tests, and gages 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 (also web-enabled). Includes usage decision and release of the stock from being in quality inspection. Follow-up actions include batch classification and quality scoring. Test Equipment Interfacing SAP ERP offers a standardized interface (QM-IDI) for connecting measuring subsystems and for external control of inspection operations on shop floor level. In addition, simple measurement systems can be connected using RS232 interfaces, keyboard wedges, serial interfaces or file transfer methods. Partner products for test equipment interfacing are also available. Statistical Process Control (SPC) SPC is the application of statistical techniques to control a process. The term statistical quality control (SQC) is often used interchangeably with statistical process control (SPC). SAP ERP supports Six Sigma approaches for analyzing measured values and nonconformance data, e.g., various quality control charts, Western Electric rules, capability indicators (cp, 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. In addition, SAP xApp for Manufacturing Integration and Intelligence (SPA xMII) can be used as a front-end to visualize quality data from SAP ERP and execute statistical process control. 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. Quality management within SAP ERP includes functionality which can compete with best-of-breed LIMS vendors. Supporting the trend of shifting from isolated data islands to global information platforms, this Enterprise LIMS reaches far beyond the borders of traditional LIMS. Because of its tight integration in the supply chain components of SAP ERP, it offers functions for inventory control and batch tracking as well as problem handling and management of preventive and corrective actions (CAPA). 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 fulfil 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 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 an inspection lot, a batch or a delivery, 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). 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. SAP ERP also supports the management of incoming certificates, which are delivered together with supplied material. 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. 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).

This process is supported by the following SAP and/or partner offerings SAP ERP Quality Improvement 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 very flexible and powerful quality notification tool.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, e.g. complaints against vendors, customer complaints, or internal problems. Corrective and Preventive Action (CAPA) and 8D Report 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 or deviations in particular. Especially for automotive suppliers, a complete 8D process can be implemented using quality notifications. 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 evaluations, Balanced Scorecards, and web reporting on inspection lots, inspection results and quality notification data (defects, tasks, actions, causes, etc.) using SAP Business Intelligence. In addition, SAP ERP provides a powerful tool for flexible ad-hoc reporting and evaluations on inspection lot data (new transaction QGA4). Six Sigma Improvement Projects (Future Focus) The Six Sigma methodology can be applied to all kind of improvement projects. The quality management application in SAP ERP and the cProjects component provide a perfect basis to define, measure, analyze, improve, and control such projects. In addition, SAP xApp for Manufacturing Integration and Intelligence (SAP xMII) can be used as platform to set up lean six sigma projects to investigate and improve manufacturing processes. Partner products are also available. This process is supported by the following SAP and/or partner offerings SAP ERP Audit Management 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. You can trigger a quality notification out of an audit finding for further processing. Evaluation of audit results can be executed using SAP Business Intelligence. The Audit Management component is very versatile can support various audit types 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)

This process is supported by the following SAP and/or partner offerings

COMPLAINT MANAGEMENT
BUSINESS SCENARIO

Key Performance Indicators

Customer Satisfaction Index Percentage of complaint solution in % of every involved department Percentage of Customer Complaints Percentage of Escalations Return Rate

SAP Partner Products Powered by SAP NetWeaver

XI Adapter

Partner Opportunities
Partner Opportunities in Pharmaceuticals Product Technical Complaints - Adverse Events

See also
SAP NetWeaver Benefits

Effective complaint management is pivotal to ensuring product quality and safety and retaining customers in competitive market. Customer complaints must be recorded and investigated (including CAPA analysis) with records retained for a specified period of time to be compliant with regulatory requirements. In addition, secure access controls visibility for tracking critical case information and performing trend analysis across the organization.

SAP is working on updates of the pricing bundles to enable best usage of our solutions by the customer and to tailor the bundles to meet customer requirements. They will be available soon.
Business Goals & Objectives

Improving Customer Service

Complaint management and tracking Improve product quality Improve service quality

Improving Regulatory Compliance

Comply with future accounting and regulatory reporting requirements Improved transparency and auditability of activities Lower risk of harm to employees and customers/clients/citizens

Processes
Complaint Capture and Processing

Improve customer service and quality by enabling call center agents to handle customer interaction across multiple channels (e.g. Web, fax, telephone) and with multiple language support to record complaint information including complete details about the contact and involved sample. Streamline response time by classifying the recorded complaint and by triggering automatic or manual routing for appropriate response or triage based on the captured attributes.
Complaint Capture Complaint Triage

Case Management

Improve service quality by automatically or manually assigning the case to the appropriate investigation or assessment group, regardless of geography or language, to promptly address the customer needs. Improve timeliness by

enabling the use of templates, searching related cases or solution proposals, tracking case status, monitoring appropriate approval hierarchy. Adhere to compliance requirements with full audit trail log.
Case Assignment Case Processing & Monitoring

Case Investigation

Request physical sample whose details were recorded during complaint capture. Route sample to the appropriate investigation or assessment group which determines the further course of action like testing product specimen in laboratory or checking process consistency in manufacturing or distribution. Case investigation also addresses compensation or delivery of an alternate product to the patient or consumer where required. Case investigation involves analysis of impact on process integrity or product safety and quality, including gathering of information from relevant departments to suggest alternative remedial actions in order to resolve the specific complaint at a faster rate and provide adequate documentation based on supportive data.
Sample Handling Detailed Investigation

Case Resolution & Closure

Improve speed of case resolution and decision making ability by presenting alternatives suggested during investigation adhering to 21CFR Part 11 requirements. Merge case related data for generation of a letter or document. Enable verification of the summary data with appropriate formatting and enforce approvals before sending out the documents through various channels of communication to involved parties like patients, physicians, sales representatives. Finally, inform involved parties and maintain the closed case record for specific duration of time.
Case Resolution & Letter Generation Case Fulfillment Case Closure

Corrective Action Preventive Action (CAPA)

Corrective and preventive action is a formal process required by regulatory authorities for categorizing the issue, documenting, tracking and implementing the findings to prevent reoccurrence of the root cause of the complaint and improving product and process quality. Root cause analysis deals with analyzing in details the source of problem by testing product and process to refine, improve and identify reasons for failure of product or

inconsistency in process operations. Electronic CAPA processing also requires satisfying regulatory requirements like 21 CFR Part 11, for example through use of digital signatures.
Corrective and Preventive Action Root Cause Analysis

To fully utilize this functionality, the following products should be evaluated

SAP ERP

Reporting & Trending Analytics

Focus on two areas: operational reporting and longer-term trend analysis. Operational reporting focuses on day-to-day work related reports for smooth functioning of the complaint management operations like number of complaints based on status, priority, region and attributes for a specific period. This tracks case information for management audit and updates thereby providing global enterprise wide visibility across sites. Monitoring of trends compares historical with current data to identify existing complaints or anticipate future complaints occurrence or accumulation in certain areas. It provides alerts for better decision making and proactively supports appropriate operations or quality group with additional relevant information in order to improve next generation products.
Reporting Proactive Monitoring

SAP QM based CAPA framework

Across the globe, companies are under constant pressure to be compliant to regulation from various regulatory bodies, customers and governments. Managing non-conformities, process deviations and critical observations in accordance with Quality guidelines across business function in an organization is an integral part of being regulatory compliant.

Corrective action and preventive action (CAPA) is one such process which can be used for categorizing the various types of issues faced during the operations of a company, documenting it, monitoring the progress and impact of the actions taken and implementing the findings to prevent reoccurrence of the major cause of the complaint and improving product and process quality. Root cause analysis deals with ascertaining the source of

problem, defect or non conformity by identifying reasons for failure of product or inconsistency in process operations and to implement corrective or preventive action to address the issue. Generally, most of the organizations use only the Defect reporting functionality in SAP, while still using the manual or non integrated system for managing or tracking corrective actions. The Defect Reporting can never ensure the non - reoccurrence of the defect/issue. SAP ERP provides a standard Quality Notification functionality where various types of incident or defects can be recorded and processed. SAP Quality Notification can be configured for an effective CAPA solution. The issues can get quick resolution as task can be defined and assigned to concerned persons who need to process the task for defect resolution. Defect Analysis can also be done to identify likely sources where most of the defects are originating. The corrective actions can be monitored using SAP business workflow to track follow up actions. Catalogs can be defined to efficiently classify the defects. Integration with SAP BI can be done for optimized reporting. Standard workflow can be used to keep track of approvals and actions taken to address the issue. The SAP based solution mostly addresses the key elements for an integrated corrective / preventive action system, which on a high level includes:-

Continuous monitoring based on documented procedures Prioritization and risk management Verification & validation Well defined procedures

Implementing SAP Quality Notification based solution enables the organization to manage defect reporting across all business processes and functions, define workflows to monitor and track actions, leverage reporting capabilities of SAP and above all enable integration with all other major business processes of the organization.