Internal AuditsInternal Audits

Presented by Charles N. DyerPresented by Charles N. Dyer

Laboratory Association of New HampshireLaboratory Association of New Hampshire

March 29, 2011March 29, 2011

© 2011 Danbury Assessment & Training Services© 2011 Danbury Assessment & Training Services

ReferencesReferences

Nelac Standards:Nelac Standards: 2003 NELAC Standard. Chapter 52003 NELAC Standard. Chapter 5

TNI StandardsTNI Standards EL-V1M2-2009EL-V1M2-2009

NELAC 5.4.13.1 / TNI 4.14.1, 4.14.5cNELAC 5.4.13.1 / TNI 4.14.1, 4.14.5c

The laboratory is required to conduct an internal The laboratory is required to conduct an internal audit of audit of allall elements of its management and elements of its management and testing activities to verify that its operations testing activities to verify that its operations comply to the comply to the NELAC/TNI StandardNELAC/TNI Standard and with the and with the requirements of the requirements of the laboratory’s quality systemlaboratory’s quality system..

The internal audit must be conducted in The internal audit must be conducted in accordance with a predetermined schedule and accordance with a predetermined schedule and procedure at least annually.procedure at least annually.

It is the responsibility of the quality It is the responsibility of the quality manager to plan and organize the audits. manager to plan and organize the audits.

The audits are to be carried out by trained The audits are to be carried out by trained and qualified personnel who are, wherever and qualified personnel who are, wherever resources permit, independent of the resources permit, independent of the activity to be audited. activity to be audited. If personnel audit their own activities it must If personnel audit their own activities it must

be demonstrated that effective audits were be demonstrated that effective audits were carried out. carried out.

NELAC 5.14.2 / TNI 4.14.2 NELAC 5.14.2 / TNI 4.14.2

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

NELAC 5.14.2 / TNI 4.14.5.aNELAC 5.14.2 / TNI 4.14.5.a

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

NELAC 5.4.13.3 / TNI 4.14.3NELAC 5.4.13.3 / TNI 4.14.3

The area audited, findings, and any The area audited, findings, and any corrective actions taken must be recorded.corrective actions taken must be recorded.

NELAC 5.4.13.3 / TNI 4.14.5NELAC 5.4.13.3 / TNI 4.14.5

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

NELAC 5.4.13.4 / TNI 4.14.4NELAC 5.4.13.4 / TNI 4.14.4

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

What the Standards Do Not SayWhat the Standards Do Not Say

The internal audit does not have to be The internal audit does not have to be conducted by one person!conducted by one person!

The entire internal audit does not have to The entire internal audit does not have to be conducted at the same time!be conducted at the same time!

Time frame for corrective actions to be Time frame for corrective actions to be completed is not stated.completed is not stated.

Time frame for notification of clients of Time frame for notification of clients of events that cast doubt on validity of results events that cast doubt on validity of results is not stated.is not stated.

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

Schedule for Conducting the AuditSchedule for Conducting the Audit

All laboratory activities must be audited at least All laboratory activities must be audited at least annually.annually.

Planned and organized by the quality manager Planned and organized by the quality manager (usually with input from supervisors)(usually with input from supervisors) All can be done at one time (usually practical only for All can be done at one time (usually practical only for

small micro or mom & pop lab)small micro or mom & pop lab) Can be organized by department or analysesCan be organized by department or analyses

Must be stated in the quality manual, an SOP or Must be stated in the quality manual, an SOP or in a policy.in a policy. Corrective actions and time frame for them must be Corrective actions and time frame for them must be

included.included.

Who Can Conduct Internal Audits?Who Can Conduct Internal Audits?

Quality ManagerQuality Manager Laboratory directorLaboratory director Supervisor(s)Supervisor(s) AnalystsAnalysts Support personnelSupport personnel Outside contractorsOutside contractors Any combination of aboveAny combination of above

Review of Quality Manual and/or PoliciesReview of Quality Manual and/or Policies

Do they meet the requirements of the Do they meet the requirements of the Standards?Standards?

Do they represent what is actually done by Do they represent what is actually done by the laboratory?the laboratory?

Are Are allall personnel following the personnel following the requirements of the quality manual and or requirements of the quality manual and or policy?policy?

Are there records to document that they Are there records to document that they are being followed?are being followed?

Review of SOPsReview of SOPs

Do they meet the requirements of the reference method? Do they meet the requirements of the reference method? If the reference method is a Standard Methods for the Analysis If the reference method is a Standard Methods for the Analysis

of Water and Wastewater, the SOP must also include the of Water and Wastewater, the SOP must also include the appropriate general SM Quality Assurance/Quality Control appropriate general SM Quality Assurance/Quality Control sections (1020, 2020, 3020, etc.)sections (1020, 2020, 3020, etc.)

““Shall”, “Must”, or similar language indicate that it is a Shall”, “Must”, or similar language indicate that it is a requirement. “Should”, “Can”, “Recommend”, or similar requirement. “Should”, “Can”, “Recommend”, or similar language are not requirements (unless made requirements 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 the requirements of the Standards? Do they meet applicable requirements of any state or federal rules Do they meet applicable requirements of any state or federal rules

and regulations?and regulations? Do they represent what is actually done by the laboratory?Do they represent what is actually done by the laboratory? Are Are allall analysts following the SOP? analysts following the SOP? Are there records to document that they are being followed?Are there records to document that they are being followed?

Records of the AuditRecords of the Audit

Records should include:Records should include:1)1) Date audit conductedDate audit conducted

2)2) Areas/activities auditedAreas/activities audited

3)3) Personnel conducting the audit.Personnel conducting the audit.

4)4) Findings of the audit.Findings of the audit.

5)5) Any corrective actions taken (Items Any corrective actions taken (Items numbered 1-3 above must be included).numbered 1-3 above must be included).

6)6) Documentation of implementation and Documentation of implementation and effectiveness of corrective actions.effectiveness of corrective actions.

Records of the Internal AuditsRecords of the Internal Audits Forms may be useful for recordsForms may be useful for records

Not required by the StandardsNot required by the Standards Example illustrated in the next slide.Example illustrated in the next slide.

Checklists may be used for recordsChecklists may be used for records NELAC or TNI Quality Systems ChecklistNELAC or TNI Quality Systems Checklist Method ChecklistsMethod Checklists

• Lab preparedLab prepared• DES preparedDES prepared

Notebooks may be usedNotebooks may be used Or any combination of aboveOr any combination of above

Auditing of Your Own ActivitiesAuditing of Your Own Activities

When possible, must be conducted by by When possible, must be conducted by by qualified personnel independent of the qualified personnel independent of the activity to be audited.activity to be audited.

““Personnel shall not audit their own Personnel shall not audit their own activities activities except when it can be except when it can be demonstrated that an effective audit will be demonstrated that an effective audit will be carried out”carried out”. .

Evidence of an Effective AuditEvidence of an Effective Audit

Did the laboratory auditor find and document Did the laboratory auditor find and document any deficiencies?any deficiencies?

Were there follow-up corrective actions taken?Were there follow-up corrective actions taken? Did the accrediting authority auditor find any Did the accrediting authority auditor find any

deficiencies?deficiencies?

If the accrediting authority auditor found very few If the accrediting authority auditor found very few deficiencies, the laboratory auditor probably did deficiencies, the laboratory auditor probably did an effective audit.an effective audit.