Training Records Your laboratory personnel are the backbone of your laboratory. Normative Documents Normative documents are those which make up or form part of your quality system. Make sure that you take the time to review this document for mistakes, changes, and updates. Not only does it restate the requirements, but there is ample room on the form to note the auditor's findings. Furthermore, it is not a bad idea to have 2 to 3 cycles of calibration reports.
You are psychologically setting the stage of the assessment in your favor. Assessors will want to review these methods to ensure that they are adequate, up to date, and validated. It too will be available in 2016 and will contain a quality manual, policies, procedures, forms, and more. You are probably right; but, I am confident that my preparation contributed to fewer deficiencies. For most laboratories, they are requirements and policy documents published by their accreditation body. To help ease the stress of your upcoming assessment, I have prepared a list of 23 items you should have readily available when your assessors walk through the door.
Corrective Actions Performed any corrective actions since your last assessment? I hope it goes well and that you get accredited. Internal audits are also quite useful in preparation for external audits. I am guessing that what mardatario is referring to is Internal Quality Audit, another victim of the acronym-saturation that we can all be victims of. Furthermore, assessors want to see how you perform root cause analysis. A horizontal audit examines every aspect of a single requirement, for example, equipment. Similar to your subcontractors list, review it and make any necessary changes prior to your assessment. Preventative Actions Implement any preventative actions? Hi, Richard, thank you for the article.
It lists all of the documents that form your quality management system. A vertical audit checks compliance of, for example, a single test through all steps from sampling to archiving of records. . Overall owners should be defined, and all employees who may be affected by the audit should be trained. This comprehensive package includes the all organized into a logical. Generally, financial audits are conducted to check if things are being carried out according to established procedures and also to discover weakness and even fraud if there's any.
Ensure that future record requests are made within the record retention policy period! I recommend putting digital copies on a flash drive or putting hardcopies in three-ring binders with tabs. However, if you are still skeptical, you cannot argue about the reduction time. Prepare copies of your corrective action records and make them available for your assessors to review. There's also a sample checklist attached. It could reduce assessment time if all of the items for every labs would have similar forms.
To make sure that you are compliant, assessors will want to see your proficiency testing schedule and the results of the tests that you participated in. Your assessors will want to see that your subcontractors are accredited to perform the services that you subcontract to them. So, I created a list of items that my assessors had frequently requested in the past. The first time that I put my list to use, I was astounded by the results. However, it is beneficial to your laboratory.
Uncertainty budgets show how you estimated measurement uncertainty and what influences contributed to your estimate. Personnel Qualifications List When assessors audit the capability of your laboratory and the competency of personnel, they request to see the qualifications list. While you at it, make a copy for yourself, so you can follow along with your assessors and see what they are seeing when they have questions. To The Point, 41 Parkstreet, 9700 Oudenaarde, Belgium, info to-the-point. If you , you will find a checklist at the end of the guide that you could print and use. Internal auditing should follow a predetermined schedule covering all activities over a reasonable period of time.
To make best use of internal audits, they should be designed, executed, and followed up very much in the same way as expected external audits. The most important thing is to know your quality system and operate in accordance with it. Hi Olesia, Thank you for your comments. Hi Dennis, Thank you for your comments. In the end, my assessments took longer and I was cited tons of deficiencies. Environmental Condition Logs Every day you monitor the environmental conditions of your laboratory. The worst part was that I was not even sure what I had been cited for until reviewing the final report after the assessment.
The more time they have, the more likely they are to find something. External auditors can come from clients or from accreditation bodies. I could also provide some samples that I will add to a future article most likely in 2016. Then, I used that list to prepare for my future assessments. Quality Manual The quality manual is the heart of your quality management system. Master Document List Your master document list is one of the key elements to your quality system.