Nonconformities report

State the reasons for the change either directly or by reference to failure reports, nonconformity reports, customer requests, or other sources. 

You could use your own reject note or nonconformity report format to notify the customer of a defective product but these are not appropriate if the product is lost. You also need a customer response to the problem and so a form that combines both a statement of the problem and of the solution would be more appropriate. 

The standard does not make it clear whether these requirements apply to nonconformities detected while the supplier is responsible for the product or after the supplier s responsibility ceases, as is the case with nonconformity reports received from customers. Reports of nonconformities are also addressed under Corrective Action in clause 4.14 but it is assumed that in this case the standard is concerned with external reports of nonconformities. 

On the labels themselves you should identify the product by name and reference number, specification and issue status if necessary and either a statement of the nonconformity or a reference to the service or nonconformity report containing full... 

On a form unique to the item, such as a nonconformity report... 

The original nonconformity report should indicate the nature of the nonconformity but after rework, or completion of operations, the nonconformity will have been eliminated. Where the nonconformity was accepted as is without rework, repair, or changing the specification then the actual condition is the original condition and this can be specified by the original nonconformity report. If the product has to be repaired or modified, the actual condition can be specified by the repair, salvage, or modification scheme, which is usually a separate document and can either be detailed on the nonconformity report or cross referenced to it. A lot of time can be saved if this information is readily accessible when problems arise later. 

Do specify the requirement as well as the actual condition on nonconformity reports. 

Don t change the design by means of a nonconformity report or concession. 

The reports of nonconformities could be internal or external reports of nonconformities although the standard does not make this clear. Internal reports of nonconformities should be covered by the requirements of clause 4.13. The next requirement concerning the investigation of nonconformities does relate to both internal and external reports. An external nonconformity report is not necessarily a customer complaint. The customer may have merely returned the product claiming it to be defective. When the customer has done this several times a complaint may well follow. 

All nonconformities are caused, all causes within your control can be avoided - all that is needed is concerted action to prevent recurrence. There are three types of corrective action product-related, process-related, and system-related. Product-related nonconformities can be either internal or external, as addressed previously, and you will have nonconformity reports to analyze. Process-related nonconformities may arise out of a product nonconformity but if you expect something less than 100% yield from the process, the reject items may not be considered nonconformities. They may be regarded as scrap. By analyzing the process you can find the cause of low yield and improve... 

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. 

Many organizations use a Nonconformity Report to deal with the remedial action and a Corrective Action Report or Request (CAR) to prevent the recurrence of one or more nonconformities. In this way you are not committed to taking action on every incident but on a group of incidents when the action and its cost can be more easily justified. 

You will need a means of recording both the cause and the proposed solutions. You can either incorporate the information within the Nonconformity Report or provide a separate Corrective Action Report. 

The nonconformance report incorporates recommendations for remedial action as appropriate. 

The measures initiated ensure timely response to the nonconformance report by authorized personnel. 

A nonconformance report should be raised for the failed instrument before any adjnst-ments are made. 

The nonconformance report should be completed, approved, filed, and made retrievable for fntnre reference. 

September 27, 1999- Control room operator discovers that two "pressurized" ton containers have been in the 90-day storage site for greater than the allowed time. Report of incident states that information transmitted to management after discovery of tons is "less than adequate,...training received on environmental inspections is inadequate." Incident results in a Government Nonconformance Report and an EG G Deficiency Report. 

RREP 15-1, Control of Nonconforming Items. The procedure establishes the controls for initiating, processing, dispositioning, and closing a Nonconformance Report. It applies to Levels I (Critical) and II (Major) items, services, data, and activities (in all of 4 groups). 

Survey reports, out-of-position piles identified with corrective actions/concessions referenced back to nonconformance reports... 

Nonconformity report (NCR), a model of which is shown in Figure 8.2... 

A DOE review of this issue determined that there was some new piping in the SSS for which corrosion evaluations had not been completed and that WSRC was aware of this. WSRC has evaluated the lack of corrosion evaluations and determined that the piping is satisfactory "as is" for at least one fuel cycle. Following the first fuel cycle, either the corrosion evaluations will be completed or the piping will be replaced. The WSRC position is being documented in a nonconformance report (NCR) justifying operation with this... 

If a part that does not meet the requirements of original design is to be used, it must be addressed by a nonconformance report. The NCR process, RDP 8.01, "Control of Nonconforming Items" (Reference 37), provides the mechanism through the use of repair, rework, use-as-is, and reject dispositions to dedicate the part or reject the part as necessary. This issue remains an open item pending the receipt and review of the plan that will address the remaining procurement related corrective actions. 

Nonconformance report training is under development by the WSRC Site Quality Department. This area was not included in the HP-8.1c training. 

The DOE staff has determined that restart training does not fully meet the restart criteria in that Reactor Restart Training did not address nonconformance reporting as delineated by ROMP HP-8.1c. Pending development and approval of the nonconformance report training lesson plan and completion of training for the appropriate Reactor Maintenance Department personnel, this issue remains an open item. 

Also, the procedure requires a written report to be submitted for each inspection and a copy to be filed in the Area History File. A copy is also to be sent to the Reactor Technology Department. However, this procedure did not state who is responsible for evaluation, acceptance, or origination of a nonconformance report. WSRC has implemented departmental procedures to resolve these deficiencies by including inspection acceptance criteria in the work packages. The staff determined that DPSOL 105-1851B, as supplemented by other inspection programs discussed below, forms an acceptable basis for restart. 

Evidence examined in the review of space shuttle material, manufacturing, assembly, quality control, and processing of nonconformance reports found no flight hardware shipped to the launch site that fell outside the limits of shuttle design specifications. 

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