Internal Audits Presented by Charles N. Dyer Laboratory Association of New Hampshire March 29, 2011 © 2011 Danbury Assessment & Training Services

References  Nelac Standards: 2003 NELAC Standard. Chapter NELAC Standard. Chapter 5  TNI Standards EL-V1M EL-V1M2-2009

NELAC / TNI , c  The laboratory is required to conduct an internal audit of all elements of its management and testing activities to verify that its operations comply to the NELAC/TNI Standard and with the requirements of the laboratory’s quality system.  The internal audit must be conducted in accordance with a predetermined schedule and procedure at least annually.

 It is the responsibility of the quality manager to plan and organize the audits.  The audits are to be carried out by trained and qualified personnel who are, wherever resources permit, independent of the activity to be audited. If personnel audit their own activities it must be demonstrated that effective audits were carried out. If personnel audit their own activities it must be demonstrated that effective audits were carried out.

NELAC / TNI  When audit findings cast doubt on the effectiveness of the operations or on the correctness or validity of the laboratory's environmental test results, the laboratory must take timely corrective action, and notify clients promptly, in writing, if investigations show that the laboratory results may have been affected.

NELAC / TNI a  The laboratory must specify, in the laboratory’s quality manual (NELAC) or in a policy (TNI), the time frame for notifying a client of events that cast doubt on the validity results.

NELAC / TNI  The area audited, findings, and any corrective actions taken must be recorded.

NELAC / TNI  Laboratory management must ensure that corrective actions are discharged within the time frame stated in the quality manual, SOP or policy

NELAC / TNI  Follow-up audit activities must verify and record the implementation and effectiveness of the corrective action taken.

What the Standards Do Not Say  The internal audit does not have to be conducted by one person!  The entire internal audit does not have to be conducted at the same time!  Time frame for corrective actions to be completed is not stated.  Time frame for notification of clients of events that cast doubt on validity of results is not stated.

These are determined by the laboratory, but must be included in the laboratory quality manual, SOPs, or policies.

Schedule for Conducting the Audit  All laboratory activities must be audited at least annually.  Planned and organized by the quality manager (usually with input from supervisors) All can be done at one time (usually practical only for small micro or mom & pop lab) All can be done at one time (usually practical only for small micro or mom & pop lab) Can be organized by department or analyses Can be organized by department or analyses  Must be stated in the quality manual, an SOP or in a policy. Corrective actions and time frame for them must be included. Corrective actions and time frame for them must be included.

Who Can Conduct Internal Audits?  Quality Manager  Laboratory director  Supervisor(s)  Analysts  Support personnel  Outside contractors  Any combination of above

Review of Quality Manual and/or Policies  Do they meet the requirements of the Standards?  Do they represent what is actually done by the laboratory?  Are all personnel following the requirements of the quality manual and or policy?  Are there records to document that they are being followed?

Review of SOPs  Do they meet the requirements of the reference method? If the reference method is a Standard Methods for the Analysis of Water and Wastewater, the SOP must also include the appropriate general SM Quality Assurance/Quality Control sections (1020, 2020, 3020, etc.) If the reference method is a Standard Methods for the Analysis of Water and Wastewater, the SOP must also include the appropriate general SM Quality Assurance/Quality Control sections (1020, 2020, 3020, etc.) “Shall”, “Must”, or similar language indicate that it is a requirement. “Should”, “Can”, “Recommend”, or similar language are not requirements (unless made requirements “Shall”, “Must”, or similar language indicate that it is a requirement. “Should”, “Can”, “Recommend”, or similar language are not requirements (unless made requirements by rules, regulations or the Standards). by rules, regulations or the Standards).  Do they meet the requirements of the Standards?  Do they meet applicable requirements of any state or federal rules and regulations?  Do they represent what is actually done by the laboratory?  Are all analysts following the SOP?  Are there records to document that they are being followed?

Records of the Audit  Records should include: 1) Date audit conducted 2) Areas/activities audited 3) Personnel conducting the audit. 4) Findings of the audit. 5) Any corrective actions taken (Items numbered 1-3 above must be included). 6) Documentation of implementation and effectiveness of corrective actions.

Records of the Internal Audits  Forms may be useful for records Not required by the Standards Not required by the Standards Example illustrated in the next slide. Example illustrated in the next slide.  Checklists may be used for records NELAC or TNI Quality Systems Checklist NELAC or TNI Quality Systems Checklist Method Checklists Method Checklists Lab preparedLab prepared DES preparedDES prepared  Notebooks may be used  Or any combination of above

Auditing of Your Own Activities  When possible, must be conducted by by qualified personnel independent of the activity to be audited.  “Personnel shall not audit their own activities except when it can be demonstrated that an effective audit will be carried out”.

Evidence of an Effective Audit  Did the laboratory auditor find and document any deficiencies?  Were there follow-up corrective actions taken?  Did the accrediting authority auditor find any deficiencies? If the accrediting authority auditor found very few deficiencies, the laboratory auditor probably did an effective audit. If the accrediting authority auditor found very few deficiencies, the laboratory auditor probably did an effective audit.