AlloyTest: preparing an extension to OES chemistry and a satellite hardness site
AlloyTest is accredited for tensile, impact and hardness testing of metallic materials at a single laboratory. It applies to extend its scope to chemical composition analysis of steels and aluminium alloys by optical emission spectrometry (OES) and to add a satellite site 200 km away where hardness testing will be performed on large castings that cannot be transported. The application names two new methods and two newly recruited technicians, states that a key proficiency testing round for OES is booked in eleven months, and attaches a lease for the satellite site signed three weeks ago. Certified reference materials for OES were bought from a distributor with no accreditation and no certificate of analysis supplied. The applicant proposes a one-day on-site assessment. The accreditation body's newly appointed chemistry technical manager, who has no metals experience, is assigned as assessor.
1. What should the pre-assessment review of this application establish, and which parts of the package already signal likely nonconformity?
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The review exists to decide two things: whether the application is complete enough to assess, and whether the laboratory can be assessed for the scope requested. Neither is a formality.
For each new method, request: validation or verification records (7.2) covering selectivity, linearity, working range, limit of detection and quantification, trueness and precision for each alloy family actually claimed; the uncertainty budget (7.6) including contributions from reference materials, drift and sample preparation; the equipment list with calibration status for the spectrometer and hardness testers; environmental control records (6.3) - OES is sensitive to temperature stability, argon quality and sample preparation; the competence and authorisation records for the two new technicians (6.2); and evidence of capability from proficiency testing or interlaboratory comparison (7.7).
Signals already visible: the reference materials are a direct 6.5 issue, because reference materials must be traceable to SI units or to a certified reference material from a competent producer, and a distributor with no accreditation and no certificate supplies neither. The absence of any proficiency testing evidence for a brand-new method is the weakest possible capability position; a round booked in eleven months is a plan, not evidence, and the laboratory must offer something else - interlaboratory comparison, comparison with a reference method, or a documented alternative - before competence can be concluded. The satellite site lease proves intention only: 6.3 requires suitable and monitored facilities, and 7.4 requires defined transport and integrity arrangements.
Conclusion: do not schedule yet. Write to the laboratory listing the missing items and state what would make the application assessable. That protects both the body and the laboratory.
2. How would you size the assessment team and the duration, and what do you do about the newly appointed chemistry technical manager?
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Size to the scope and the risk, not to the applicant's preference. Risk factors here: two new technical areas, one new site, two new staff, no proficiency testing evidence, and a chemistry scope in which competence must be traced through the whole process - sample preparation, standardisation, drift correction, reference material use, result calculation.
That profile argues for a technical assessor competent in metals by OES, a technical assessor or technical expert for hardness at the satellite site (if the body's own competence does not cover it), and a lead assessor carrying the management-system clauses and the site-sampling logic. Duration: two assessors for two days at the main site plus one day at the satellite site with the hardness assessor. The satellite site must be visited, not assessed by interview, because the entire point of the extension is that the activity happens there.
The newly appointed chemistry technical manager cannot be the sole assessor. ISO/IEC 17011 requires assessors to be competent in the scope assessed, and a new appointment does not waive that. She may act as lead for the management-system clauses if her competence supports it, paired with a metals technical expert for the technical scope, and she must not sign off technical competence she cannot judge. Brief her, pair her, and record the competence justification in the assessment file.
Finally, plan the sampling inside the assessment - which methods, which analysts, which shift, which instrument - and put the rationale in the assessment plan, sent in advance so records and staff are available. An assessment plan that names the sampling logic is also the best defence if the laboratory later says it was not given the chance to demonstrate conformity.
3. The laboratory's sales team has promised customers accredited OES results from next month and pressures the body to keep the one-day date. What is the correct response and what should be recorded?
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Refuse clearly, in writing, with reasons tied to the standard and the body's procedures, and offer a realistic date. Compressing the assessment to meet a sales commitment would misrepresent the accreditation process and mislead the laboratory's own customers, which is exactly the harm accreditation exists to prevent. The laboratory's commercial promise is not a criterion the body may assess against.
Honest options: assess what is ready and defer the remainder; structure the report so that the items with sufficient evidence can be recommended and the others held pending evidence - but the recommendation is the assessor's, and the decision belongs to the accreditation decision-maker, not to the assessor and certainly not to the applicant. The laboratory also needs the correct commercial message: it may report results outside its accredited scope provided the report makes clear that those results are not covered by accreditation (7.8.2). That is a lawful route to serving customers next month, and it is the laboratory's management that must decide whether to use it.
Record: who made the request, on what date, what commercial commitment was described, what the lead assessor answered and what was agreed. Traceability protects the body's impartiality if the laboratory later complains or escalates. If the laboratory insists on the deadline, it may withdraw and reapply; that is its choice and should be stated neutrally. What must not appear in the file is any hint that the assessment scope or duration was adjusted because of a customer deadline.