Rework instructions

An auditor would expect to find staff consulting the rework instructions when carrying out rework. However, information in documents can be memorized or become habit through familiarity with the process. Rework instructions are often unique to the nonconformity and therefore personnel cannot rely on prior knowledge. This is addressed as a supplementary requirement in clause 4.14.3. 

Prior to commencement of production, design changes do not require any modification documentation, the design changes being incorporated in prototypes by rework or rebuild. However, when product is in production, instructions will need to be provided so that the modification can be embodied in the product. These modification instructions should detail ... 

Rework means the continuation of processing that will make an item conform to specification. Rework requires only normal operations to complete the item and does not require any additional instructions. Rework when applied to documents means correcting errors without changing the original requirement. 

Whatever the scope of the project, clear communication of the exact work plan is enhanced by providing a detailed description of the activities and the expectations. Merely listing activities, as presented in Table 3, is grossly inadequate and will result in numerous iterations in contract proposals as the CROs request more specific instructions and rework their proposals accordingly. Some questions to be considered when providing details of the work plan and deciding which CRO to select are as follows ... 

Regrind consists of reworked material, i.e. either natural plastic or plastic plus other constituents as per material being moulded. Regrind is usually used to specific levels, e.g. 10%, 15%, 20%, 25% maximum. However, continuous use of regrind may lead to some degradation of either the basic polymer or the other constituents. If regrind is not permitted a specific instruction has to be included in the specification. Some countries do not permit the use of regrind for certain types of product (e.g. for IV, injectibles.)... 

Special instructions for the recovery/reworking of reject packs produced on the line to minimise contamination. 

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