Quality system nonconformities

Quality systems shall not be registered to ISO/TS 16949 if open minor or major nonconformities to ISO/TS 16949 exist. 

A major nonconformity is a noncompliance that judgement and experience indicate is likely either to result in the failure of the quality system or to materially reduce its ability to assure controlled processes and products. 

It also implies that not all major nonconformities are indicative of a failure of the quality system to prevent shipment of defective product. 

Are documented procedures employed to determine the cause of nonconformities in products, processes, and the quality system and to prevent their recurrence ... 

How do you ensure that, when needed, personnel have the organizational freedom to identify and record product, process, and quality system problems, provide solutions and initiate action to prevent the occurrence and recurrence of any nonconformities ... 

Many suppliers will already have methods in place that cover many of the requirements of ISO/TS 16949. What they may not have done, however, is to integrate these methods into a system that will cause conformity and prevent nonconformity. The ISO 8402 definition of a quality system makes it clear that a quality system is not just a set of procedures. It is the organization structure, processes, and resources to manage the achievement, control, and improvement of quality. 

Don t work to instructions unless provided in the quality system procedures, product specification, production plan or in approved change notices or remedial action instructions or by the nonconformity review board. 

The definition of nonconformity in ISO 8402 states that it is the nonfulfillment of specified requirements therefore a nonconforming product is one that does not conform to the specified requirements. Specified requirements are either requirements prescribed by the customer and agreed by the supplier in a contract for products or services, or are requirements prescribed by the supplier which are perceived as satisfying a market need. This limits the term nonconformity to situations where you have failed to meet customer requirements. However, ISO 8402 1987 suggests that nonconformity also applies to the absence of one or more quality system elements, but clearly the requirements of clause 4.13 cannot be applied to nonconformity with quality s /stem requirements. Both ISO 9001 and ISO 9004 only address nonconformity in the context of products, processes, and services and when addressing quality system elements the term deficiencies is used. Some auditors use the term nonconformity to describe a departure from the requirements of ISO 9001 but it would be preferable if they chose the term noncompliance to avoid any confusion. The requirements of clause 4.13 therefore only apply to products, processes, and services and not to activities, quality system elements, or procedures. 

Note that these are not the same as the nonconformity classifications used in assessing quality systems see Part 1 Chapter 5. 

Failure investigation procedure Nonconforming material review procedure Customer complaints procedure Quality system document change procedure Specification change procedure Maintenance procedures... 

The standard requires the supplier to investigate the cause of nonconformities relating to product, process, and quality system and record the results of the investigation. The supplementary requirements require the supplier to use problem-solving methods when an internal or external nonconformity occurs. 

One important aspect of the quality systems approach is the ongoing collection and analysis of quality data to continuously evaluate quality system effectiveness. Historical data, process knowledge, and risk analysis methods can be applied to identify specific data requirements. Trending and other data analysis methods can allow identification of actual and potential sources of nonconformity so that appropriate corrective and preventive actions can be taken in accordance with established change control procedures. 

A key component in any quality system is appropriately responding to nonconformities (i.e., deviations from requirements established under the quality system for in-process material or final product quality attributes, process control parameters, records, procedures, etc.). Nonconformities may be detected during any stage of the... 

Corrective and preventive action (CAPA) is the term commonly used to describe the subsystem of a comprehensive quality system that deals with the systematic investigation, understanding, and response to quality issues including nonconformities. A corrective or preventive action may be initiated based on review and analysis of quality data from a variety of sources including adverse experiences, product complaints, quality audits, FDA inspections, third-party inspections, nonconforming materials reports, process control information, trend analyses, and other sources. 

A corrective action is initiated to correct the cause of an identified nonconformity and to prevent it or similar problems from reoccurring. It may include initial and follow-up actions (e.g., conducted after root cause analysis). Current quality system models and the cGMP regulations emphasize corrective actions and require that actions be documented. Under current quality system models, preventive actions include actions taken in response to quality data to address the cause of potential nonconformities to prevent their occurrence. An effective CAPA system therefore includes both reactive and proactive components. The effectiveness of corrective and preventive actions should be evaluated using objective criteria when possible and the evaluation documented. 

Failure to validate computer software used as part of the quality system for its intended use according to an established protocol as required by 21 CFR 820.70(i). For example, the data in the Excel spreadsheet identified as a hit list of top nonconforming components contains 16 record counts for part number 8601618 DC converter failures compared to 18 record counts for part number 860168 DC converter failures in the dbase database. The spreadsheet is used for management review of component suppliers for all components. 

Qause 8.3 is on control of nonconformity. This is a requirement to identify rmd control product that is in nonconformance and to take appropriate action to see that such product does not reach the customer. The next subclause requires data dealing with the quality system to be collected and analyzed. These data include customer satisfaction and dissatisfaction, conformance to requirements, characteristics of processes and products, emd suppliers. 

Nonconformance refers to the condition where a product or system is developed with one or more characteristics that do not conform to the development requirements and/or specifications. Nonconformance is a departure from, or a failure to conform to, design requirements or specifications. Nonconformance results in failure of an item to perform its required function as intended. An item may be a system, subsystem, product, software, human, or component. As applied in quality assurance, nonconformance falls into two categories (a) discrepancies and (b) failures. 

Quality Audit. Another important responsibiUty of quahty assurance is the audit function. Using the quahty audit as a tool, QA can monitor the operation of the manufacturing faciUty a toU, ie, contract, manufacturer or raw material suppHer to assure that written procedures are in place and that there is documentation to indicate the procedures are being followed. Properly executed audits allow QA to spot potential weakness in the quahty system that could allow errors to occur. Once identified, these weaknesses can then be corrected before they result in nonconformance. 

Quality Audit is the only option available to them. It is therefore vital that, to ensure standards of quality are maintained, a laboratory must operate its own internal audits to test its quality management system. If the internal system of audits is not operating adequately, external assessment visits are liable to be traumatic experiences, awaited with trepidation and producing unexpected and embarrassing nonconformities in several areas of operation. 

The major category of nonconforming work is allocated for any failure of a system to comply with the requirements of the Standard which could lead to invalidity of test results. Examples include absence/non-implementation of a document control system, absence/non-implementation of a procedure for internal audit or management review, staff not technically competent to perform particular tests and failure to control the quality of test data. 

The intermediate category of nonconforming work is allocated when a number of related minor failures are observed, which together are judged to be an unacceptable quality risk, without constituting an overall system failure in the areas concerned. 

Several method performance indicators are tracked, monitored, and recorded, including the date of analysis, identification of equipment, identification of the analyst, number and type of samples analyzed, the system precision, the critical resolution or tailing factor, the recovery at the reporting threshold level, the recovery of a second reference weighing, the recovery for the control references (repeated reference injections for evaluation of system drift), the separation quality, blank issues, out of spec issues, carry over issues, and other nonconformances. The quantitative indicators are additionally visualized by plotting on control charts (Figure 23). 

The laboratory shall establish a policy and procedure and shall designate appropriate authorities for implementing corrective action when nonconforming work or departures from the policies and procedures in the quality management system or techiucal operations have been identified. The procedure for corrective action shall start with an investigation determining the root cause(s) of the problem. 

Audits should assess whether the actual quality improvement and safety activities comply with planned activities. The effectiveness of the overall quality and safety system should be scrutinized. Fundamental procedures and methods should be investigated to insure they are up-to-date and being followed in actual practice. The focus of the audit should be prevention, that is, finding areas needing improvement before they actually turn into situations that generate nonconformance. 

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