Title: Internal Audit Standard Operating Procedure and Simplified Quality System Checklist

Approved by:

Technical Director

______________________________ (Name) ______________________________ (Signature)

_______________ (Initials)     _________________ (Date)

Quality Assurance Officer

______________________________ (Name) ______________________________ (Signature)

_______________ (Initials)     _________________ (Date)

Revision History

Rev	Date		Description of Change
1	9/5/07	Name	Initial Release
2	01/13/13	Name	Updated all sections. Reformatted Appendix A.

Distribution List / Location

This SOP is to be distributed to those individuals involved in the internal audit process of the lab.

Annual Review (The review is to be documented if the document has not been revised in the past 12 months)

_______________________              ____________________                 _______

Signature                                             Title                                                     Date

______________________                ____________________                 _______

Signature                                             Title                                                     Date

___________________                      ____________________                 _______

Signature                                             Title                                                     Date

______________________                ____________________                 _______

Signature                                             Title                                                     Date

___________________                      ____________________                 _______

Signature                                             Title                                                     Date

Training Record

The following laboratory staff have read and agree to follow the latest version of the SOP.

_____________________      ______________________    _______       _______

Signature                                 Name                                       Initials             Date

_____________________      ______________________    _______       _______

Signature                                 Name                                       Initials             Date

_____________________      ______________________    _______       _______

Signature                                 Name                                       Initials             Date

_____________________      ______________________    _______       _______

Signature                                 Name                                       Initials             Date

_____________________      ______________________    _______       _______

Signature                                 Name                                       Initials             Date

Table of Contents

1. Purpose. 5

2. Scope. 5

3. Responsibilities. 5

4. Procedure. 6

5. Related Documentation and References. 8

6. Definitions. 8

APPENDIX A.. 9

1. Purpose

§  To ensure that the procedures in the quality manual, related to quality systems, and the lab’s method manual, related to testing activities, are being followed.

§  To determine the effectiveness of the lab’s procedures in controlling the quality of data reported

§  To identify, correct, and implement any changes needed in any of the quality system and testing activities procedures found to be deficient

§  To ensure all deficiencies in the lab’s quality system and testing activities are documented though its corrective action process

2. Scope

The internal audit SOP and associated checklist is used to audit, on an annual basis, the lab’s quality system, policies and procedures, work instructions, analytical records, and reports.  In addition, the lab audits its testing activities (each method-technology) on an annual basis.

3. Responsibilities

Quality Assurance (QA) Manager or QA Officer (QAO):

°         is knowledgeable and trained in quality system requirements, including internal audits

°         initiates all internal audits and ensures they are conducted in an efficient and timely manner

°         delegates responsible, trained staff, if applicable, to carry out specific audits of testing activities

°         notifies laboratory management , including the technical director, of any deficiencies (findings) in the quality system or testing activities

°         documents and monitors corrective actions

°         documents and tracks staff who have completed auditor training

Auditor:

°         has completed auditor training

°         has sufficient experience in performing audits

°         performs audits in an efficient and timely manner

°         reports all findings to the QAO

4. Procedure

4.1 The Audit Team

The Quality Assurance Manager or QA Officer (QAO) selects trained staff, if applicable, to perform the audits defined in this procedure.  If trained staff is limited, the QAO and/or technical director may perform the audits.  If trained staff is not limited, the QAO will designate one of the trained staff to serve as the lead auditor.  When ever possible, auditors are selected from a function not directly involved in the audit.

4.2 Training

Auditors are trained in auditing techniques.  Training consists of reading and understanding this procedure and reference material related to internal auditing, and where possible, shadowing a trained auditor or completing a formal, external training course. The auditors are also provided with the applicable auditing guidelines and checklists. Both quality system and method-specific checklists are to be provided to the auditor.

Evidence of the training includes a signature that the auditor has read and understands this procedure (see page 3). It may also include documentation of any external seminars or course work related to quality system auditing.  All training records are to be kept for a minimum of five years.

4.3 Audit Plan

The entire quality system, including testing activities, is audited on an annual basis.  The maximum interval between audits is twelve months.  The frequency may be adjusted for new procedures or deficiencies that resulted from complaints.

The QAO creates the audit schedule. The audit schedule defines the following:

°         timeframe of the audit

°         scope of audit

°         elements and/ or areas to be audited

4.4 Performing the Audit

The QAO notifies the supervisors of the areas to be audited at least a month in advance. The QAO briefs the auditors on the audit procedures and the areas to be audited.  The auditors are to prepare prior to the audit by familiarizing themselves with the audit procedures.

During the audit, auditors use applicable checklists.  They record all findings on the checklists. The findings are discussed with the staff responsible for performing the function that was found to be deficient.

4.5 Deficiency Report and Corrective Action Response

A deficiency report is generated by the auditor for each legitimate finding.  The QAO makes the final decision as to whether the finding is legitimate if it can not be resolved between the auditor and the staff audited.  The QAO presents the final report to the audited staff, as well as, laboratory management, including the technical director.

The audited staff responds to the deficiency report in a manner prescribed by the lab’s corrective action procedures, which are included in the Quality Manual.  The corrective action must be completed within 90 days of the date of the finding.

When deficiencies cast doubt on the correctness or validity of the calibration or test results reported, the lab needs to immediately notify its clients of the situation.  A record of the client notification must be maintained.

4.6 Closing an Audit

Audit findings are closed upon completion of an effective corrective action for each of the findings.  All documents related to the audit, including checklists, deficiency reports, corrective action responses, are maintained by the QAO.

4.7 Review and Evaluation

The QAO verifies successful implementation of the corrective action by observing objective evidence supplied by the audited staff as part of the corrective action process.  Follow-up is performed by the QAO, or designated staff, as part of the next scheduled audit to verify the effectiveness of the corrective actions that were implemented.  IN addition, the QAO reviews the audit report with laboratory management, including the technical director, as part of the lab’s annual management review.

5. Related Documentation and References

Audit Plan

Audit Checklists, including method-specific checklists

Deficiency (Audit) Report

Corrective Action Response (CAR)

Corrective Action Procedures as noted in Quality Manual

National Environmental Laboratory Accreditation Conference (NELAC), 2003 NELAC Standard, Approved June 5, 2003, Effective July 1, 2003, 324 pp (EPA/600/R-04/003).

National Environmental Laboratory Accreditation Conference (NELAC), 2009 NELAC Standard, Approved August 24, 2009, Effective July 1, 2011.

New York State Department of Health (NYS DOH) Environmental Laboratory Approval Program (ELAP), method-specific checklists,

http://www.wadsworth.org/labcert/elapcert/appforms.htm

New York State Department of Health (NYS DOH), NYCRR Subpart 55-2, Approval of Laboratories Performing Environmental Analysis, Sections 55-2.1 through 55-2.12 effective November 17, 2004, and Section 55-2.13 effective October 6, 2004.

6. Definitions

Audit Finding - A conclusion of importance based on observation(s).  An undesirable deviation or nonconformity.

Corrective Action - Action taken to eliminate the root cause(s) and the symptom(s) of an existing undesirable deviation or nonconformity to prevent recurrence.

Objective Evidence - Verifiable qualitative or quantitative observations, information, records, or statements of fact pertaining to the quality of a product or service or to the existence and implementation of quality system element.

Quality Audit - Systematic and independent examination to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives

            APPENDIX A

TOPIC	Y	N	N/A	Comments
Organization & Management
1.)  Does the laboratory have a policy to ensure its personnel are free from any commercial, financial and other undue pressures, which might adversely affect the quality of the work?
2.) Does the laboratory specify and document the responsibility, authority, and interrelation of all personnel who manage, perform or verify work affecting the quality of calibrations and tests in job descriptions for all positions.
3.) Does the laboratory have documented certifications that personnel performing all tests for which the laboratory is accredited have the appropriate educational and/or technical backgrounds?
4.) Does the laboratory nominate deputies in the case of absence of the technical director or QA officer?
5.) Does the laboratory have documented policies and procedures to ensure the protection of clients' confidential information and proprietary rights?
Quality System
1.) Is the quality documentation available to, understood by, and implemented by all laboratory personnel?
2.) Does the quality manual and related quality documentation include the objectives and commitments by top management?
3.) Does the quality manual and related quality documentation include the organization and management structure of the laboratory, its place in any parent organization, and relevant organizational charts?
4.) Does the quality manual and related quality documentation include procedures to ensure that all records required under NELAC are retained?
5.) Does the quality manual and related quality documentation include procedures for control and maintenance of documentation through a document control system which ensures that all standard operating procedures, manuals, or documents clearly indicate the time period during which the procedure or document was in force?
6.) Does the quality manual and related quality documentation include procedures for achieving traceability of measurements?
7.) Does the quality manual and related quality documentation include a list of all methods under which the laboratory performs its accredited testing?
8.) Does the quality manual and related quality documentation include mechanisms for ensuring that the laboratory reviews all new work to ensure that it has the appropriate facilities and resources before commencing such work?
9.) Does the quality manual and related quality documentation include reference to the calibration and/or verification test procedures used?
10.) Does the quality manual and related quality documentation include procedures for handling submitted samples?
11.) Does the quality manual and related quality documentation include reference to the major equipment and reference measurement standards used as well as the facilities and services used by the laboratory in conducting tests?
12.) Does the quality manual and related quality documentation include reference to procedures for calibration, verification and maintenance of equipment?
13.) Does the quality manual and related quality documentation include reference to verification practices including inter-laboratory comparisons, proficiency testing programs, use of reference materials, and internal quality control schemes?
14.) Does the quality manual and related quality documentation include procedures to be followed for feedback and corrective action for failed quality control samples, or when departures from documented policies, procedures, or NELAC standards occur?
15.) Does the quality manual and related quality documentation include procedures for dealing with complaints?
16.) Does the quality manual and related quality documentation include processes/procedures for establishing that personnel are adequately experienced in the duties they are expected to carry out and/or receive any needed training?
17.) Does the quality manual and related quality documentation include processes and procedures for educating and training personnel in their ethical and legal responsibilities including the potential punishments and penalties for improper, unethical, or illegal actions?
18.) Does the quality manual and related quality documentation include reference to procedures for reporting analytical results?
19.) Does the quality manual and related quality documentation include a Table of Contents, and applicable lists of references and glossaries, and appendices?
20.) Does the QA officer keep the quality manual current?
21.) Does the QA officer arrange for or conduct internal audits on the entire technical operation annually and notify laboratory management of deficiencies in the quality system and monitor corrective action
22.) Where a complaint, or any other circumstance, raises doubt concerning the laboratory's compliance with the laboratory's policies or procedures, or with the requirements of this Standard or otherwise concerning the quality of the laboratory's calibrations or tests, does the laboratory ensure that those areas of activity and responsibility involved are promptly audited?
23.) Does the laboratory have a procedure for the annual management review of the quality system?
24.) Is an annual review of the quality system completed by management to evaluate its continuing suitability and effectiveness and make any necessary changes or improvements?
25.) Does the annual review take into account reports from managerial and supervisory personnel, the outcome of recent internal audits, assessments by external bodies, the results of interlaboratory comparisons or proficiency tests,  any changes in the volume and type of work undertaken, feedback from clients, corrective actions and other relevant factors?
26.) Are all audits and review findings and any corrective actions that arise from them documented?
27.) Does the laboratory management ensure that corrective actions are discharged within the agreed time frame?
28.) Does the laboratory implement checks to monitor the quality of laboratory results using: _a__ Internal quality control procedures (using statistical techniques whenever possible); _b__ Participation in PT or other interlaboratory comparisons; _c__ Reference material and/or in-house quality control using secondary reference materials; _d__ Replicate testing; _e__ Re-testing of retained samples; and/or _f__ Correlation of results for different parameters of a sample.
29.) Does the laboratory have general procedures to be followed when there are departures from documented policies, procedures, and QC have occurred?
30.) Do the procedures to be followed when there is a departure from documented policies, procedures, and QC include but not limited to: a___ Identify the individuals responsible for assessing each QC data type; b___ Identify the individuals responsible for initiating and/or recommending corrective actions; c___ Define how the analyst should treat the data set if the associated QC measurements are unacceptable; d___ Specify how out-of-control situations and subsequent corrective actions are to be documented; and e___ Specify procedures for management (including the QA officer) to review corrective action reports.
31.) Is a corrective action log maintained, up-to-date?
32.) If a QC measure is out of control and the data is to be reported, are data qualifiers reported with samples associated with failed QC measures?
33.) Are all quality control measures assessed and evaluated on an on-going basis, and quality control acceptance limits used to determine the usability of the data?
34.) Does the laboratory have procedures for the development of acceptance/rejection criteria where no method or regulatory criteria exist?
35.) Are the quality control protocols specified by the laboratory’s method manual followed?
Training
1.) Are training records available for all technical staff that include: a___ Evidence that the employee has read, understands, and is using the latest version of the lab’s in-house quality documentation; b___ Training courses or workshops on specific equipment, analytical techniques, or lab procedures; c___ Training courses in ethical and legal responsibilities including the potential punishments & penalties for violations. d___ Evidence that the employee has read; acknowledges, and understands their personal & legal responsibilities including potential punishments & penalties for violations; and e___ Documentation certifying that the employee has read, understands, and agrees to use the latest version of a test method used; and
2.0 Are initial demonstrations, continuing demonstrations and method certification documented through the use of the forms in the latest approved NELAC document in Appendix C?
3.) Does the laboratory use another approach, documented in its Quality Manual, to demonstrate capability for analytes for which spiking is not an option and for which quality control samples are not readily available?
4.) Does the laboratory retain all associated supporting data necessary to reproduce the analytical results summarized in the IDC certification statement?
5.) Is a copy of the initial demonstration of Capability Certificate (IDC) in the personnel records for each employee performing a test method?
6.) Do the training records of each of the technical staff include documentation of continuing proficiency by at least one of the following: ___ Acceptable performance of a blind sample; ___ Another demonstration of capability; ___ Successful analysis of a blind performance sample on a similar test method using the same technology; a ___ Analysis of at least 4 consecutive lab control samples with acceptable levels of precision and accuracy; or ___ If one of the above can be performed, the analysis of authentic samples that have been analyzed by another trained analyst with statistically indistinguishable results.
7.) Does the laboratory complete a new demonstration of capability whenever there is a significant change in instrument type, personnel, or test method?
8.) Has the laboratory management developed a proactive program for the detection of improper, unethical, or illegal actions?
Equipment
1.) Are maintenance procedures documented?
2.) Is each item of equipment including reference materials labeled, marked or otherwise identified to indicate its calibration status, when appropriate?
3.) Are maintenance records available?
Support Equipment Calibration and Traceability
1.) Does the laboratory have an established program for the calibration and verification of its measuring and test equipment including balances, thermometers and control standards?
2.) Are measurements made by the labs traceable to national standards of measurement where available?
3.) Does the laboratory maintain records of all certificates that indicate traceability to national standards of measurement and/or statements of compliance with an identified metrological specification?
4.) Is all support equipment calibrated annually, using NIST traceable references when available, over the entire range in which the equipment is used?
5.) Are the results of support equipment calibration within the specifications required of the application for which it is used?
6.) Is support equipment removed from service until repaired or is a deviation curve prepared and all measurements corrected for the deviation when the calibration is not within acceptance limits?
7.) Does the laboratory maintain records of established correction factors to correct measurements?
8.) Are all raw data records retained to document equipment performance?
9.) Prior to use on each working day, are balances, ovens, refrigerators, freezers, incubators and water baths checked with NIST traceable references (where possible) in the expected use range?
10.) Are mechanical volumetric devices checked for accuracy on a quarterly basis?
11.) Demonstration of sterilization for biological tests provided by use of a continuous temperature recording or with the frequent use of spore strips?
SOPS and Test Methods
1.) Does the laboratory have SOPs for all test methods?
2.)  Are all instructions, standards, manuals and reference data relevant to the work of the laboratory maintained up-to-date and readily available to the staff?
3.) Are copies of SOPs assessable to all personnel?
4.) Does each SOP clearly indicate: a___ Effective date of the SOP b___ Revision number c___ Signature(s) of approving authority
5.) Does the laboratory have an in-house method manual for each accredited analyte or test method that clearly describes the lab’s method?
6.) In cases where modifications are made to published methods or where the reference test method is ambiguous or provides insufficient detail, are any modifications, changes, or clarifications clearly indicated?
7.) Are the practices specified by the laboratory’s method manual followed by all analysts?
8.) Are all essential quality control measures incorporated in the lab’s method manual?
9.) Are all quality control measures assessed and evaluated on an on-going basis?
10.) Does the laboratory have procedures for developing acceptance/rejection criteria for each test method?
11.) Do the SOPs or the test method SOP reference the details of the initial calibration procedures, including calculations integrations, and acceptance criteria associated statistics?
12.) Is the criteria for the acceptance of an initial calibration established (correlation coefficient or relative percent difference)?
13.) Are the details of the continuing instrument calibration procedure, calculations, and associated statistics included or referenced in the test method SOP?
14.) Does the laboratory establish Standard Operating Procedures to ensure that the reported data is free from transcription and calculation errors?
15.) Does the laboratory establish Standard Operating Procedures to ensure that all quality control measures are reviewed, and evaluated before data is reported?
16.) Are calculations and data transfers subject to checks as established in the laboratory’s SOP?
17.) Do documented procedures exist for the purchase, reception and storage of consumable materials used for the technical operations of the laboratory?
18.) Does the laboratory retain records for all standards, including manufacturer/vendor, the manufacturer’s Certificate of Analysis or purity (if supplied), date of receipt, recommended storage conditions, and an expiration date after which the material shall not be used unless verified by the laboratory?
19.) Are original reagent containers labeled with the expiration date?
20.) Are detailed records maintained on reagent and standard preparation?
21.) Do the records of reagent and standard preparation indicate traceability to purchased stocks or neat compounds, and include the date of preparation and preparer's initials?
22.) Are containers of prepared reagents and standards uniquely identified and include an expiration date and can it be linked to the documentation of its preparation?
Sample Handling
1.) Does the laboratory have a documented system for uniquely identifying the items to be tested, to ensure that there can be no confusion regarding the identity of such items at any time?
2.) Does the laboratory assign a unique identification (ID) code to each sample container received in the laboratory?
3.) Is the laboratory ID code placed on the sample container as a durable label?
4.) Is the laboratory ID code entered into the laboratory records (see 5.11.3.d) and does the link that associate the sample with related laboratory activities such as sample preparation or calibration?
5.) Does the laboratory have a written sample acceptance policy that clearly outlines the circumstances under which samples will be accepted?
6.) Is data from any sample which does not meet the policy criteria flagged in an unambiguous manner clearly defining the nature and substance of the variation?
7.) Is the sample acceptance policy made available to sample collecting personnel and does it include at a minimum all the policy criteria?
8.) Upon receipt, is the condition of the sample, including any abnormalities or departures from standard condition as prescribed in the relevant test method, recorded?
9.) Are all items specified in sample acceptance policy criteria checked?
10.) Are all samples, which require thermal preservation, considered acceptable if the arrival temperature is either within +/-2°C of the required temperature or in the method specified range?
11.) For samples with a specified temperature of 4°C, are samples maintained within a temperature of just above freezing to 6°C?
12.) In cases where samples are hand delivered to the laboratory immediately after collection and do not meet the temperature criteria considered acceptable, is there evidence that the chilling process has begun such as arrival on ice?
13.) Does the laboratory have procedures for checking chemical preservation using readily available techniques, such as pH, free chlorine or temperature, prior to or during sample preparation or analysis?
14.) Does the laboratory implement procedures for checking chemical preservation using readily available techniques, such as pH, free chlorine or temperature, prior to or during sample preparation or analysis?
15.) Are the results of all checks recorded?
16.) If the sample does not meet the sample receipt acceptance criteria does the laboratory do any of the following: ___ Retain correspondence and/or records of  conversations concerning the final disposition of rejected ___ Fully document any decision to proceed with the analysis of samples not meeting acceptance criteria ___ Is the condition of these samples, at a minimum, noted on the chain of custody or transmittal form and laboratory receipt documents? ___ Is the analysis data of these samples appropriately "qualified" on the final report?
17.) Does the laboratory utilize a permanent, sequential log, such as a logbook or electronic record, to document receipt of all sample containers?
18.) Is the following information recorded in the laboratory chronological log? a___ Client/Project Name b___ Date and time of laboratory receipt of sample c___ Unique laboratory ID code (see 5.11.1) d___ Signature or initials of the person making the entries
19.) Are samples stored away from all standards, reagents, food and other potentially contaminating sources in such a manner as to prevent cross contamination?
20.) Are samples, sample fractions, extracts, leachates or other sample preparation fractions stored according to the conditions specified by preservation protocols or according to the test method?
21.) Does the laboratory have standard operating procedures for the disposal of samples, digestates, leachates and extracts or other sample preparation products?
Records
1.) Does the laboratory retain on record all original observations, calculations and derived data, calibration records and a copy of the test report for five years?
2.) Does the record keeping system allow historical reconstruction of all laboratory activities that produced the resultant sample analytical data?
3.) Is the history of the sample readily understood through the documentation including inter-laboratory transfers of samples and/or extracts?
4.) Do the records include the identity of personnel involved in sampling, preparation, calibration or testing?
5.) Are all documentation entries signed or initialed by responsible staff with the reason for the signature or initial clearly indicated in the records? (Ex. “sampled by”, “prepared by”, reviewed by”)
6.) Are all generated data, except those that are generated by automated data collection systems, recorded directly, promptly and legibly in permanent ink?
7.) Are entries in records not obliterated by methods such as erasures, overwritten files or markings?
8.) Are all corrections to record-keeping errors made by one line marked through the error and the individual making the correction signing (or initialing) and dating the correction?
9.) Do records that are stored or generated by computers or personal computers (PCS) have hard copy or write-protected backup copies?
10.) Does the laboratory have a record management system for control of laboratory notebooks; instrument logbooks; standards logbooks; and records for data reduction, validation storage and reporting?
11.) Is access to archived information documented with an access log?
12.) Is archived information protected against fire, theft, loss, environmental deterioration, and vermin and, in the case of electronic records, electronic or magnetic sources?
Reports
1.) Does the test report contain all information necessary for the interpretation of the test results and all information required by the method used?
2.) Does the facility management ensure that the appropriate report items are in the report to the regulatory authority if the report is prepared by another individual within the organization.
3.) Where the certificate or report contains results of tests performed by sub-contractors, are these results clearly identified by subcontractor name or applicable accreditation number?
4.) Does the laboratory certify that the test results meet all requirements of NELAC or provide reasons and/or justification if they do not?
Chemistry Quality Control (To be used with the method checklist)
1.) Is a method blank performed 1 per batch, per matrix type per sample extraction or preparation method?
2.) Is the analysis stopped, corrected and the problem eliminated if the blank contamination is greater than 1/10th of the measured sample contamination or 1/10th of the regulatory limit; or are the results reported with appropriate data qualifying codes?
3.) Is an LCS (a sample matrix free of analytes of interest spiked with a verified known amount of analyte) analyzed at a minimum of 1 per batch of 20 or less samples per matrix, per sample extraction or preparation method except for analytes for which spiking solutions are not available?
4.) Is a matrix spike (sample prepared by adding a known mass of target analyte to a specific amount of matrix sample) performed at a frequency of 1 in 20 samples per matrix, per sample extraction or preparation method?
5.) Is a matrix spike duplicate (MSD) or laboratory duplicate performed at a frequency of 1 in 20 samples per matrix, per sample extraction or preparation method?
6.) Is the initial instrument calibration used directly for quantitation?
7.) Is the continuing instrument calibration verification used to confirm the continued validity of the initial calibration?
8.) Are all initial calibrations verified with a standard obtained from a second source?
9.) If the results of samples are not bracketed by the initial calibration, are the results reported as having less certainty (defined qualifiers, flags, or explanation in the case narrative)?
10.) Is the lowest calibration standard of the initial calibration above the detection limit?
11.) When an initial calibration is not performed on the day of analysis, does the laboratory verify the validity of the initial calibration prior to the analysis of samples by analyzing a continuing instrument calibration verification sample?
12.) Is continuing instrument calibration verification repeated at the beginning and end of each analytical batch?  (If an internal standard is used, only one continuing calibration verification must be analyzed per analytical batch)
13.) Are the concentrations of the continuing calibration standard varied within the established calibration range?
14.) Are sufficient raw data records retained to permit reconstruction of the initial calibration including: a___ Calibration date b___ Test method c___ Instrument d___ Analysis date e___ Each analyte name f___ Concentration g___ Response h___ Calibration curve or response factor
15.) Does the laboratory use detection limits that are determined by the protocol in the mandated test method or applicable regulation?
16.) Is the quality of water sources monitored and documented to meet method specified requirements?
Quality Control for Bacteriology (To be used with the method checklist)
1.) Are temperatures of incubators and water baths recorded twice daily (morning & afternoon) as required by the methods as indicated below: a. ____            Total Coliform bacteria incubation at 35.0 +/- 0.5 degrees Celsius (SM9221B, SM9221D, SM9222B & EPA-600/8-78-017) b. ____            Fecal Coliform bacteria incubation at 44.5 +/- 0.2 degrees Celsius (SM9221E, SM9222D, & EPA-600/8-78-017) c. ____            Total Coliform & Escherichia coli (E. coli) incubation at 35.0 +/- 0.5 degrees Celsius (SM9223 + UV; Colilert, Idexx-18, & Colisure) d. ____           E. coli incubation at 44.5 +/- 0.2 degrees Celsius (EC with MUG or Nutrient Agar with MUG)
2.) Is the following support equipment associated with microbiological testing checked with NIST traceable materials (where possible) a. ____ pH meter b. ____ Balance(s) c. ____ Conductivity meter d. ____ Refrigerator(s) for sample storage and/or media storage e. ____ Incubators f. ____ Water baths
3.) Is a minimum of one uninoculated control prepared and analyzed?
4.) When the same equipment is used to prepare multiple samples does the laboratory prepare at least one blank at the beginning, one at the end, with additional blanks inserted after every 10 samples?
5.) Is a known negative culture analyzed with each set of samples.
6.) Is each lot of media tested on a monthly basis with at least one pure culture of a known positive reaction (positive control)?  (Not required if the laboratory has at least one known positive result of the appropriate organism during the month).
7.) Is the positive control test tested with a sample test batch?
8.) Are at least 5% of the suspected positive samples analyzed in duplicate?
9.) In laboratories with more than one analyst performs the testing does each analyst make parallel analyses on at least one positive sample per month?
10.) Are the calculations, data reduction and statistical interpretations specified by each method followed?
11.) Where the method specifies colony counts, such as membrane filter or colony counting, is the ability of individual analysts to count colonies verified at least once per month, by having two or more analysts count colonies from the same plate?
12.) In order to demonstrate traceability and selectivity, does the laboratory use reference cultures of microorganisms obtained from a recognized national collection or an organization recognized by the assessor body?
13.) Are the graduations of the temperature measuring devices appropriate for the required accuracy of measurement?
14.) Are records maintained on all laboratory reagent water monitoring activities as below when dilution water and/or media are prepared in house: a_ Residual Chlorine < 1.0 mg/L. b_ Conductivity < 2.0 umho/cm at 25 degrees Celsius c_ Heterotrophic Plate Count < 1000 cfu per mL. d_ Bacteriological ratio 0.8 – 3.0. e_ Cd, Cr, Cu, Ni, Pb, Zn each < 0.05 mg/L, collectively < 0.1 mg/L. f_ Records maintained for the past five years?