XL Environmental - Library -Implement An Effective QA/QC Program To Manage Your Product Liability Risk

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Implement An Effective QA/QC Program To Manage Your Product Liability Risk A QA/QC program, when made an integral part of a company's risk management program, can help control a company's risk, such as product liability and general liability exposures. An important step to mitigate product liability exposures is the development of a QA/QC manual. The manual pulls together the organization's ideas, provides the framework for the QA/QC program, and integrates it into the company's daily operations. Some of the simplest QA/QC manuals are the most useful; they need not be multiple-volumes long. A simple QA/QC program may include at least the following: A Written Corporate QA/QC policy, which includes management's objectives for the program. The objectives may include the company's QA/QC philosophy and should identify the standards the organization must meet. The standards may be internal goals or industry standards. The policy should also state management's commitment to QA/QC including revenue, manpower and other resources. A Procedure for Receiving Raw Materials should include guidelines on how personnel receive incoming raw materials and how the raw materials should be inspected to assure that they meet in-house, industry and/or client specifications. It is recommended that all raw materials be assessed in a quantifiable manner to assure they meet their specifications. The procedure should provide testing methods and criteria to gauge the raw materials. Visual inspection is sufficient for only the simplest of materials. The goal of incoming inspection is to provide the company a defensible position if their product is questioned at a later date. Simple analysis such as viscosity or moisture content may be enough depending on the specifications and product. Some companies request Certificates of Analysis from suppliers; however, depending on the product, an independent or random sampling and analysis may be desired to assure that the material meets the requirements. The sampling should be documented on a form. Procedures to Assess the Production Process . Some companies find it useful to test products at intermediate points during the production process. The goal of this inspection is to assess the extent of production in order to operate efficiently and, at the same time, assure that the final product meets its specifications. The inspection should be documented on a form such as a batch ticket. Finished Product Inspection/Analysis . This section must provide the type of analysis required and what criteria must be met for each product produced prior to its release to clients. The section should designate who samples, analyzes and reviews the results and who has the authority to release the product once it meets the specifications. The company may want to test at the completion of production as well as prior to packaging, and/or shipping to insure the product has not degraded. The analysis and approval for release should be documented on a form such as a batch ticket. Depending on the product, a retain sample should also be obtained and kept for at least the shelf life of the product if not longer. Again, the goal of this inspection is to provide the company a defensible position if the quality of the product is questioned at a later date. Procedures for Non-Conforming Materials . This section should first identify what the organization defines as a non-conforming material/product. It should indicate who is responsible for identifying non-conforming materials, who should be notified, how non-conforming materials should be labeled, and where the non-conforming material should be placed or segregated to insure it is not used, shipped or sold. The section should provide guidelines for a documented investigation into what made the material non-conforming. In some industries, such as the paint and coatings industry, non-conforming materials can be reused or reworked. This section should also provide the criteria for what non-conforming materials can be reused and what should be disposed of. An Outline for Document Control, details how the organization will document their QA/QC steps. This section should detail how products are labeled and identified by their unique batch number. This section should also have an overall company records retention policy specifying when and how documents are gathered, stored and destroyed in order to insure their traceability. Procedures for Material Handling, Storage, Packaging and Shipping . This section should detail how material is handled, stored, labeled/packaged and shipped from the time raw materials are received until the final product is shipped. The section should include how and where materials are placed and segregated prior to release either into production or shipping. It should be noted that the amount of material control and segregation is dependent on the materials used and produced, and is at the discretion of the organization. This section should also dovetail with the organization's Hazard Communication program to provide labeling requirements for both raw materials and final products, as well as guidelines for the development and distribution of Material Safety Data Sheets and technical data sheets. Program and Manual Review Procedures , which outline guidelines for the periodic review and revision of the program. All programs need periodic review and/or revision as operations change or mature. The amount of time between reviews depends on the organization and operation; however, at least an annual review is suggested. This section should also provide a framework for internal and, if needed, external audits of the program to insure it is functioning correctly. Audits can provide feedback for modification. The procedure should indicate how often audits should occur, what should be covered, and who should conduct them. Audits can be as simple as one-page checklists. Customer Complaint and Product Recall Procedures . The organization should develop procedures to handle and document customer complaints including who should take the initial contact, who has the authority to make decisions, what managers or departments should be contacted and how the complaint should be documented. The section should also detail how a product will be recalled including who should authorize the recall and how customers will be identified and contacted. With regard to ISO... While strict conformance to ISO certification is an individual decision that each company must consider, at a minimum it is recommended that they practice under "ISO-like" procedures, without the registration and auditing elements. Use of the ISO 9000 series can impact product liability two main ways. Establishing a quality system can improve the inherent safety of the product or service, which should result in less frequent or severe claims. Also, the documentation developed as part of implementing the quality program may be allowable as evidence in product liability lawsuits. It is important to understand that implementation of ISO 9000 is not a legal defense in and of itself; nor does the failure to implement an ISO 9000 program itself create liability. In most cases, conformance with ISO 9000 is voluntary. An organization that chooses to model their quality management system on ISO 9000 will create a large amount of documentation that may be relevant in a product liability lawsuit. This documentation may be relevant to show the conduct of an organization if that conduct is in dispute, such as when negligence is claimed or punitive damages are requested. Complete and well-maintained documentation can show that the organization acted in a reasonable manner and took systematic steps to improve product safety. Conversely, poorly kept or incomplete documentation may present the organization in a negative light. " XL Insurance" is a registered trademark of XL Group plc. XL Insurance is the global brand used by member insurers of the XL Group companies. For general information purposes only. Contents should not be construed or used as legal advice or opinion. © 2005 XL Specialty Insurance Company. All rights reserved. XL Insurance 520 Eagleview Blvd PO Box 636 Exton, PA 19341-0636 Tel: +1 800-327-1414 Fax: +1 610-458-8667


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