Nonconforming work

During an audit, a failure to comply with any component of the relevant Standard(s) is recorded as nonconforming work or observations. There are a... 

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. 

The nonconforming work that will require evidence of implementation of corrective and preventive action within a given timescale will include matters, such as, no corrective action taken when the results from a round of a Proficiency Testing scheme indicated the laboratory s result was an outlier, or the competency records of staff do not indicate they are competent to do the accredited work. Listings of nonconformities can be found in a publication produced by the International Laboratory Accreditation Cooperation (ILAC) [9]. 

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. 

Once the process has been commissioned (i.e. set to work) trials can be conducted to optimize the process parameters. When special causes of nonconformity have been removed, process verification can commence. Process verification consists of a number of activities ... 

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. 

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. 

Regarding processes and work operations you will need to establish performance indicators as a means of determining whether the potential for generating nonconformities is present. Establish standards for each of the processes and collect data on how well the standards are being achieved. Such factors as quantity processed, process yield, time... 

The standard requires personnel whose work affects quality to be informed of the consequences to the customer of nonconformities with quality standards. 

The consequences of nonconformities are different for the different categories. Minor nonconformities will be noted and checked at the next assessment but will not normally appear in the written report. Major nonconformities can result in a total suspension of accreditation or suspension of accreditation for particular work. The intentional misuse of the accreditation body logo or mark is considered to be a serious nonconformity. If, after a previous warning, a laboratory continues to issue test reports showing the accreditation logo when the tests are outside the scope of the accreditation it can result in withdrawal of accreditation. Accreditation can be withdrawn for a particular area if it is found that accommodation is inappropriate and it is impossible to avoid cross contamination of samples. 

Fire safety practices such as housekeeping, hot work permits, and elevated work should be in place during installation. The owner s representative should make periodic progress inspections to check for nonconformance issues and good work practices. 

Control of the activities (control of nonconforming testing and/or calibration work, improvement, corrective action, preventive action, internal audits, management reviews)... 

A bottom-up approach may be used to follow up on a specific quality problem identified from trend analyses, product nonconformities, adverse experiences, customer complaints, or other sources of quality data. Starting with quality records associated with the problem, the auditor will work his or her way up through the... 

Subsection 4.9 Control of Nonconforming Testing or Calibration Work... 

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. 

Analyzing all processes, work operations, concessions, quality records, service reports, and customer complaints to detect and eliminate potential causes of nonconforming product... 

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. 

The nonconforming items are suitably identified by labels and removed from the work area. 

In addition to the roving inspection, a finished piece inspection is performed each half hr that is, the inspector randomly selects for examination one finished unit from the end of the line. In our example, the finished unit is a unitized bundle of 12 bottles of 100 tablets each. Each finished piece is tom down into its component parts, which are examined for specific attributes and conformance to the work order. Table 12 summarizes the tests made by the inspector, as well as the number of pieces examined at each half-hr interval. When nonconformance is detected, a notation is made in the inspection record. With 13 finished product audits performed on each shift, a considerable pool of information is readily amassed. 

Additionally, contracts may be negotiated for payment or milestones. This challenges the vendor to keep to the time line and complete the tasks in order. Incentives for completing work early can be included. Penalties for nondeliverables or the cost for nonconformance can also be defined. This provides an incentive for the vendor to reach and maintain an appropriate level of compliance. 

Yet unless I am mistaken the argument made by Tesser and Achee differs in an important respect horn the one I am making here. Although they refer to Brehm s work about pressure to conform generating anticonformism,113 their main interest is actually in conformism versus nonconformism. Elsewhere I have described these antonyms... 

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