Nonconformities procedure

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. 

Is there a written procedure for handling nonconformance with quality of service ... 

Are documented procedures employed to prevent the inadvertent use or installation of nonconforming products ... 

Are customer complaints and reports of product nonconformities handled in accordance with documented procedures ... 

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

Are documented procedures employed to detect and eliminate potential causes of nonconformance and prevent their occurrence ... 

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. 

This requirement can impose unnecessary constraints if you take it literally. Many activities in quality plans and procedures are performed to give early warning of nonconformities. This is in order to avoid the losses that can be incurred if failure occurs in later tests and inspections. The earlier you confirm conformance the less costly any rework will be. 

The standard requires the procedures for control of nonconforming product to apply to any product which fails to pass any inspection and/or test. 

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. 

The standard requires the supplier to review nonconforming product in accordance with documented procedures and advises that it may be ... 

In order to implement these requirements your nonconformity control procedures should include the following actions ... 

Decide what products and processes will be governed by the nonconformity control procedures. 

As the source of nonconformities are so varied it may not be practical to have a single corrective or preventive action procedure. It may be more practical to embody corrective action provisions in the following procedures ... 

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

There is only a requirement for a record of changes in procedures and not changes in plans, specifications, and drawings, which are clearly not procedures, but whether it be procedures, work instructions, or other types of instructions, you will need to be able to demonstrate that you have a system for preventing the recurrence of nonconformities. 

The standard requires the corrective action procedures to include the effective handling of reports of product nonconformities. 

Assuming that the standard is only referring to external reports of nonconformities, your procedures should cover very similar processes to those for handling customer complaints. The procedures should cover ... 

Your corrective action procedures need to cover the collection and analysis of product nonconformity reports and the collection and analysis of process data to reveal process nonconformities. The corrective action provisions of your internal audit procedure need to address the causes of the nonconformities and you will need an additional procedure to deal with external audits, investigating the cause of any nonconformities and recording the results. The procedure also needs to cover the investigation of customer complaints as the previous requirement only deals with the handling of complaints. 

The standard requires corrective action procedures to include determining the corrective action needed to eliminate the cause of nonconformities. 

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 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. 

Preventive action is taken to eliminate the causes of potential nonconformities in order to prevent their occurrence. Corrective action refers to the activities taken to correct something done (e.g. a non-conformity) whilst preventive action refers to the activities so that to avoid something not to be done. The elements of the documented preventive action procedure are shown in this slide. 

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. 

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... 

Nonconformances may fall into the category of manpower, machinery methods, materials, etc. Employees not following procedures or unable to execute required steps of the process indicate a poorly designed process requiring modification and/or improved training. Machinery failures often indicate poor qualification, validation, calibration, or maintenance programs. Unexpected results or outcomes are indicative of poor process design, characterization, or a break down between processes. 

Nonconformance arises when any aspect of the work of a laboratory does not conform to its procedures, to the standard, or the agreed-upon requirements of the customer. These are detected by customer complaints, internal quality control measures, management audits and reviews, and by observations of staff. They must be dealt with under the appropriate part of the management system and fully investigated and reported. 

A product that does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. The controls and related responsibilities and authorities for dealing with a nonconforming product are defined in a documented procedure. 

Consideration is given to the control exercised at the source and documented evidence of quality conformance provided. All incoming materials are inspected or otherwise verified as to conforming to specified requirements before being released for use to production. This verification is in accordance with the quality plan or documented procedures. All incoming materials released for urgent production purposes are positively identified and recorded in order to permit immediate recall in the event of nonconformance. 

The [procedures] provide for identification, documentation, evaluation, and segregation when practical, as well as disposition of nonconforming product and notification to the functions concerned. 

The responsibility for review and authority for the disposition of nonconforming product is assigned to a [material review board]. Nonconforming product is reviewed in accordance with [material review board procedures]. 

The product requirements are reviewed before the contract or tender is accepted. Product requirements are defined and communicated to the personnel responsible for the quality production. The unresolved and ambiguous issues are resolved and documented. The changes made in the product specifications are approved before execution of the order. Provisions are made for removing absolute drawings, procedures, work instructions, and specifications from all work areas to ensure that they are correctly authorized versions. Provisions are made for emergency changes necessary to prevent the production of nonconforming material. 

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