On-Site Evaluations and the Application Process

Become familiar with ch. NR 149, the Laboratory Certification and Registration Code. At the time a laboratory signs the application for certification or registration, it, as an entity, agrees to comply with the ch. NR 149 Code in its entirety and to follow quality control procedures specified in it. The auditor is only verifying compliance with the NR 149 Code and the methods of analysis. It is therefore wise to understand the code requirements and the methods. The auditor may also make some suggestions that fall under "good laboratory practices" which are helpful.

Review historical Program performance in meeting audit goals.

Preparing for an On-Site Evaluation

What do you need to do to prepare for an on-site evaluation? Before the Department evaluates your laboratory, you should review your lab's quality assurance plan and operating procedures for compliance with:

• Chapter. NR 149, Wis. Adm. Code,
• The approved methods of analysis, and
• The "Manual for the Certification of Laboratories Analyzing Drinking Water, 5th ed." (January 2005)

Helpful Hints for a Successful Evaluation

Review ch. NR 149, the Laboratory Certification and Registration Code.

At the time a laboratory signs the application for certification or registration, it, as an entity, agrees to comply with the ch. NR 149 Wis. Admin. Code in its entirety and to follow quality control procedures specified in it. The auditor is only verifying compliance with the NR 149 Code and the methods of analysis. It is therefore wise to understand the code requirements and the methods. The auditor may also make some suggestions that fall under "good laboratory practices" which are helpful.

Provide the auditor with key facility information prior to the visit.

The DNR files contain basic information about the laboratory, but it is always useful to familiarize the auditor in advance with particular or unusual aspects of the facilities operation. The more the person knows about the facility, the quicker the evaluation will proceed. Some items that are commonly requested are:

• The facility's quality manual and SOPs
• An updated list of analytical equipment in use at the laboratory
• An organizational chart or personnel roster
• Copies of variances or alternate test procedure approvals obtained by the laboratory
• A schematic layout of the laboratory
• Directions on how to reach the laboratory
• Initial demonstrations of capability (precision and accuracy studies)
• Summary of your lab's quality control limits

An auditor may request items not on the above list. If the laboratory is using methods that are different from those listed on the laboratory's application, or its quality assurance manual, it is important to inform the auditor of these changes before the visit so that they can adequately prepare for the evaluation.

Organize the laboratory records.

A key feature of the Laboratory Certification Program is its insistence on "documentation". The auditor will need to see evidence that the laboratory is complying with the various requirements of the Code. A substantial portion of the auditor's time at the laboratory will be spent perusing records. Organize the laboratory's records to provide maximum availability, accessibility, traceability and clarity. Be prepared to provide the following to the auditor:

• Log of samples received at the laboratory
• Bench sheets or laboratory notebooks
• Quality control records
• Corrective action records
• Maintenance records of laboratory instruments

This is a list of some items that may be requested. The auditor may request any information or document used to confirm compliance with Wisconsin's requirements. It is a common practice during laboratory evaluations to select several samples at random and "track" them through the laboratory's record system. Conduct this paper audit yourself at your laboratory to detect and correct any possible problems or system flaws before the visit.

Organize the laboratory equipment.

The auditor will take a tour of the laboratory and check that the instruments, chemicals and equipment needed to perform the tests for which the laboratory is seeking or has certification or registration for are available. Purge the laboratory of unnecessary equipment and chemicals, discard expired stock solutions and make sure that current standards are explicitly labelled and dated.

Be realistic about the efforts to improve the laboratory's operation shortly before an audit. The interval between the auditor's contact and actual evaluation can be efficiently used to do a little "house cleaning", but would not be enough time to devise, revise and implement a full quality assurance program.

Also, please review any previous on-site inspection reports and make sure that any previously noted deficiencies have been corrected!!

The Audit Response

Any deficiencies identified during the on-site inspection will need to be corrected and must be documented to the Department before the audit can be resolved. Documentation of the corrections should contain how the problem was corrected and actual data proving the implementation of the correction such as photocopies of log book pages, bench sheets, calibration information or raw data. The auditor will inform the laboratory of what is needed in its response to the evaluation report. Since the response is historically the most time consuming process of the evaluation, listen to the auditor and read the report carefully. Submitting a complete and acceptable initial response is the quickest way to become certified or resolve any enforcement action. It is to the laboratory's advantage to submit exactly what the auditor asks for, which is designed to verify compliance. This may sound simple, but most laboratories submit two or more responses before it is complete and acceptable, which more than doubles the time needed to solve the non-compliance issue. The result of multiple submittals is a longer wait for certification or registration, a longer duration for the Notice of Noncompliance or Violation, or a possible escalation in enforcement.