prescribed in guides, instructions and check sheets. Results of inspections and other activities are recorded and maintained.

If the verification is to be done by the supplier, and the purchaser visits the inspection site for observation checks, the procedures and the release approval conditions (delivery conditions) shall be prescribed as purchasing requirements.

Examples of a verification process are:

1. acceptance inspections, in-process inspections and delivery inspections performed by the purchaser itself;

2. observation checks at in-process inspections and delivery inspections done by the supplier,

3. documentary examinations of quality records or work reports, and

4. audit of the supplier.

If the checks of only the final product are considered insufficient for verification, for example the final report of outsourced analytical design work, it will be effective to plan and execute in- process verification, depending on the importance of the product to be purchased. This is prescribed clearly in the purchasing requirements.

Examples of such activities are:

1. checks in the stage of computer program verification;

2. checks of input data bases;

3. checks of analytical results; and

Table10.7.1 Examples of purchase requirements

i ) Requirements concerning approval of products, procedures, processes and equipment

a - Scope of suppliers

b .Name, Number, Version and Articles, as needed, of applied statutes and codes

c .Numbers of purchased product

d .Technical requirements for purchased product

e . Documents and records to be submitted (specifications, design documents, guides and instruction manuals for manufacturing/tests/maintenance, etc., drawings, quality assurance plans, work practice plans, QC process charts, test and inspection reports, etc.)

f .Design and development

g .Audit

h .Purchasing management by suppliers

i .Verification process of purchased product at the suppliers’ sites

j .Identification and traceability

k .Reporting and treatment when a nonconformity occurs

1 .Prevention of recurrence of nonconformities

ii) Requirements concerning competence checks of personnel

a .Education and training corresponding to personnel qualifications, such as foreman training.

b .Competence and qualification of personnel engaging in special (non-conventional) work processes

| iii) Requirements concerning the quality management system

NSRA, Japan

10-22