Title: Laboratory Quality Manual

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Laboratory Address:
Telephone Number:

Approved by:
Technical Director
______________________________ (Name)
(Signature)
_______________ (Initials)

______________________________

_________________ (Date)

Quality Assurance Officer

______________________________ (Name)
(Signature)
_______________ (Initials)

______________________________

_________________ (Date)

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Revision Record
Revision
No.
1
2
3

Date
10/21/99
3/20/00
12/27/02

Responsible
Person
Name
Name
Name

7/01/04

Name

7/08/05

Name

6
7

8/05/05
5/17/07

Name
Name

8
9

8/21/09
05/20/10

Name
Name

10

05/25/1107
/22/11

Name

Description of Change
Initial Release
Section 21, Appendix A
Record Retention moved to Document Control
Section; New information for Reports Section,
expanded Corrective action, new section for
confidentiality and proprietary rights. Section 4
merged into Job Description Section, section
renumbered
Added Quality System and Preventive Action
sections. Renamed New Work to Review of
Requests, Tenders, and Contracts. Renamed and
expanded Testing Discrepancies to Control of
Nonconforming Testing. Renamed and expanded
ethics training to data integrity.
Organization chart moved to Appendix B.
Editorial changes to Job Descriptions.
Expanded Document Control to include annual
review. Editorial changes to Lab Environment.
Renamed section 12 to Verification Practices and
removed lab split sampling and interlaboratory round
robins.
Updated internal audit & managerial review
requirements in section 19B &C.
Revised section 8 C, MDL is now LOD and LOQ.
Added Quality Records to section 3. Added to
section 19 C managerial review list.
Added measurement uncertainty to section 22.
Add reports section and update confidential reporting
mechanism
Reformatted document, Added forms
Minor edits, Added Microbiology and removed
outdated methods from section 2, Updated section 9
to include TC and Temp
Added NELAC 2009 References

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Annual Review (The review is to be document if the Quality Manual 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 and Signature Log

The following laboratory staff have read and agree to follow the current Quality Manual. In
addition, these staff are responsible for signing and/or initialing laboratory records.
_____________________
Signature

______________________
Name

_______
Initials

_______
Date

_____________________
Signature

______________________
Name

_______
Initials

_______
Date

_____________________
Signature

______________________
Name

_______
Initials

_______
Date

_____________________
Signature

______________________
Name

_______
Initials

_______
Date

_____________________
Signature

______________________
Name

_______
Initials

_______
Date

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Table of Contents
Section No.
No.

Section Heading

Page

1. Quality Policy...........................................................................................................................5
2. Accredited Test Methods.........................................................................................................6
3. Quality System.........................................................................................................................6
4. Job Descriptions of Staff..........................................................................................................7
5. Document Control....................................................................................................................7
6. Traceability of Measurements..................................................................................................8
7. Review of All Requests, Tenders and Contracts.......................................................................9
8. Calibration/ Verification of Test Procedures.............................................................................9
9. Sample Handling....................................................................................................................10
10.
Laboratory Environment....................................................................................................12
11.
Procedures for Calibration, Verification, and Maintenance of Equipment.........................13
12.
Verification Practices..........................................................................................................14
13.
Internal Quality Control Procedures..................................................................................14
14.
Control of Non-Conforming Environmental Testing..........................................................15
15.
Corrective Action Procedure..............................................................................................15
16.
Exceptionally Permitted Departures from Documented Policies and Procedures or From
Standard Specifications..................................................................................................................16
17.
Preventive Action...............................................................................................................16
18.
Complaints and Feedback..................................................................................................16
19.
Internal Audit and Data Review.........................................................................................17
20.
Training and Review of Personnel Qualifications...............................................................18
21.
Data Integrity.....................................................................................................................19
22.
Reporting Analytical Results..............................................................................................20
23.
Records..............................................................................................................................22
24.
Confidentiality and Proprietary Rights...............................................................................22
25.
References..........................................................................................................................22
26.
Appendix A - Organization Chart.......................................................................................24
27.
Appendix B Master List of Documents...........................................................................25
28.
Appendix C Complaint/Corrective / Preventive Action Log...........................................26
29.
Appendix D - Code of Ethics.............................................................................................27

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Quality Policy

It is the Laboratorys objective to produce technically defensible laboratory test results that
accurately and precisely describe the sample for the purpose of reporting to the client (New York
State for treatment plants). The Laboratory is committed to routinely performing laboratory work
in conformance to NYCRR Subpart 55-2, the NELAC Standard (2003 and 2009) adopted by
New York State ELAP, resulting in the overall improvement in laboratory quality over time.
Demonstration of the laboratorys commitment to reach its objective will result in the following:
* Adequately staffed and equipped laboratory facility,
* Successful participation in the proficiency testing program operated by the New York State
Environmental Laboratory Approval Program or another accredited provider,
* Successful implementation of a NELAC compliant quality system,
* Annual internal audits with management review,
* Successful biennial assessments by the New York State Environmental Laboratory Approval
Program, or Primary Accrediting Authority,
* Timely reporting of laboratory test results to the regulating authorities/clients,
* Laboratory test results that are supported by quality control data and documented laboratory
testing procedures.
The quality policy is communicated to employees during the training of new hires. It is
understood, implemented, and maintained by employees at all levels. This is documented by
management through the employee evaluation process, the training procedure, the internal audit
process, and the document control process. The technical director shall ensure that the labs
policies and objectives for quality of testing services are documented in the Quality Manual. The
technical director shall assure that the Quality Manual is communicated to, understood, and
implemented by all personnel concerned. Documentation includes signed statements in each
analysts training file.

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Accredited Test Methods

Test
pH
Temperature
Biochemical Oxygen Demand
Total Suspended Solids
Total Kjeldahl Nitrogen
Total Coliform/E. Coli Qualitative
E. Coli Enumeration

MethodA
SM 18 4500-H-B
SM 18 2550 B
SM 18 5210 B
SM 18 2540 D
SM 18 4500NH3C
SM 18 9223B (Colilert)
SM 18 9223B (Colilert)

CategoryB
NW
NW
NW
NW
NW
PW
NW and PW

Standard Methods for the Examination of Water and Wastewaters, 18th Edition, APHA, AWWA.
WEF, 1992.
B
NW Non-potable water; PW Potable water
A

3.

Quality System

The quality system defined in the quality manual applies to all personnel who perform activities
affecting quality. All employees are responsible for the quality system. The individual documents
define specific employee responsibilities.
Though a formal documented system of planned activities, the quality system meets of the
relevant requirements of ISO guide 17025, NELAC Chapter 5, July 2003, NELAC Volume 1,
Module 2 Section 1.1, July 2011, and the New York State Department of Health, Environmental
Laboratory Approval Program. The quality manual is maintained current and up-to-date by the
Quality Manager (QAO) to reflect changes to the system. The laboratory defines it policy for
each applicable standard element in the quality manual. For each element, as appropriate, the
laboratory has documented procedures that further describe how the specific policy objectives and
goals are met. The quality manual references these documented procedures. Where applicable,
work instructions are referenced in the documented procedures and the quality manual.
Quality procedures and instructions are implemented as written. The procedures explain how the
laboratory implements the standard requirements in accordance with its quality policy. They are
revised, as necessary, to reflect the actual objectives, flow of tasks, and staff responsibilities.
Work instructions are maintained in the laboratory methods manual. They specify the equipment
and fixtures required the resources and skills, what tests and verifications will be performed to
measure process and product quality, the records and written documentation used by personnel,
and standards of acceptability. Work instructions are approved by the affected managerial staff
and are maintained in the document control system.
Document Structure
Level 1Quality Manual
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Level 2Quality Procedures

Level 3Work Instructions and Test Procedures
Level 4Quality Records
4.

Job Descriptions of Staff

Technical Director (TD) / Laboratory Director- The technical director has overall responsibility
for the technical operation of the lab. The TD is also responsible for arranging and overseeing all
support services including instrument service contracts, subcontracting sample analyses, and
physical maintenance of the laboratory. The TD also interacts with departmental,
interdepartmental and appointed/elected officials to participate in coordination of lab participation
in departmental/ interdepartmental projects. The TD reports directly to the department head.
The technical director is responsible for providing supervision to all laboratory personnel to
ensure adherence to lab documented procedures. When the technical director is not present in the
lab, an employee who is familiar with test procedures, the objective of the testing and the
assessment of results will be appointed by the technical director to supervise.
The technical director shall certify that personnel with appropriate educational and/or technical
background perform all tests for which the lab is accredited. Documentation can include New
York State Treatment Plant Operators licenses for government municipal treatment plant labs.
Quality Assurance Officer (QAO) - The quality assurance officer has responsibility for the
quality system and its implementation. The QAO has direct access to the highest level of
management at which decisions are taken on lab policy and/or resources, and to the technical
director. (For a small lab, the QAO may also be the technical director.) When the QAO is not
present, a deputy shall be appointed.
Laboratory Technician / Operator Lab Technicians are responsible for reading and following
SOPs, performing appropriate QC checks, and informing the Technical Director when problems
occur.
An organizational chart is included in Appendix A.
5.

Document Control

All operating procedures, manuals including this quality manual, and documents are subject to
document control. Distribution of controlled documents is limited to those indicated on the
document distribution list. Controlled documents are indicated by the paper color indicated in the
footer (i.e., ivory). Uncontrolled copies are indicated by reproduction on any other color of
paper. The QAO controls the supply of paper used to produce controlled copies.
The purpose of the document control system is to ensure that only the most recent revisions are
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available to the appropriate personnel, revisions are timely, and receive the required approvals.
All internal regulatory documentation, standard operating procedures, work instructions, service
manuals, and product instructions are under document control. The QAO is responsible for the
document control system and keeps a master list of the location of all documents and their current
revision (Appendix B). The TD and the QAO approve all newly released documents and revised
documents. Any employee can request a change to a document. Obsolete documents may be
retained for legal reasons or for knowledge preservation. The QAO stores retained obsolete
documents. All documents produced by the laboratory will contain the following information:

effective date,

revision number,

document number,

page numbers (including total number of pages), and

document title.
Controlled documents will also include an approval signature page, a revision (change record)
history page, and distribution list.
All SOPs and internal controlled documents are reviewed once per year. If a document is revised
during the year the revision record in the document shall demonstrate review. If a document has
not been revised during the year, the review record shall be the signature of the person responsible
for the document and the date of the review.
Amendment of documents is allowed. The document control system allows for amendment of
documents by hand pending re-issue. Such amendments are clearly marked, initialed and dated.
A revised document is formally re-issued as soon as practically possible.
All data, including original observations, calculations and derived data, calibration records, QC
records, and copies of the test reports, resulting from the analyses of samples are recorded and
kept for five years (ten years for potable water samples) to allow historical reconstruction of the
final result.
6.

Traceability of Measurements

Verification and/or validation of equipment, such as, balances, thermometers, and

spectrophotometers, shall be performed with National Institute of Standards and Technology
(NIST) traceable standards. Calibration certificates must indicate NIST traceability along with
measurement results and the associated uncertainty and/or a statement of compliance with an
identified metrological specification, such as tolerance. Reference standards, such as Class S
weights and NIST traceable thermometers, are used for calibration only and shall be calibrated by
an organization that can provide traceability to NIST. Volumetric glassware, if not serialized and
calibrated by the manufacturer or Class A, is checked quarterly in house using a documented
gravimetric technique.

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Review of All Requests, Tenders and Contracts

All new work is initiated by the Technical Director who delegates responsibilities for the new
work according to available resources. Affected staff members meet prior to initiation of new
work in order to determine if appropriate facilities and resources are available. The plan for any
new testing shall be reviewed and approved by the technical director before commencing such
work. If the review uncovers any potential conflicts, deficiencies, inappropriate accreditation
status, and/or inability to perform the work, the laboratory shall notify the client. In cases where
differences exist between the request/tender and contract they shall be resolved prior to starting
work.
The review shall document that facilities and resources are organized to efficiently perform the
work, including subcontracted work. The record of contract review includes pertinent discussions
with the client regarding their requirements and results submitted during the contract period. For
routine reviews of ongoing work a date and a signature of the laboratory official responsible for
the contract is sufficient. For any new testing requirements, the designated official shall ensure
that standard operating procedures and demonstration of capability to perform those tests prior to
reporting results are available. The SOP(s) shall be under document control and a Demonstration
of Capability statement(s) shall be on file. Copies are held in the contract review file.
Clients are notified immediately in situations where the laboratory cannot conform to the contract
and if the there is a change in laboratory accreditation status.
8.

Calibration/ Verification of Test Procedures

Calibration and/or verification procedures are designed to ensure that the data will be of known
quality and be appropriate for a given regulation or decision. Details of instrument calibration
and/or test verification procedures including calibration range, standardizations, calculations and
acceptance criteria are included or referenced in each test method SOP.
Sufficient raw data are retained to reconstruct the calibration used to calculate the sample result.
All calibrations are verified with a second source standard which is traceable to a national
standard, when available.
Calibration standards include a concentration at or below the regulatory/decision level but above
the laboratorys detection limit.
Results of samples must be within the calibration range (bracketed by standards) or the results
must be flagged as having less certainty.
No data associated with a calibration that is out-of-control will be reported.
Limit of Detection (LOD) and Limit of Quantitation (LOQ) The LOD may be determined by
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using the MDL procedure described in 40-CFR Part 136 or another documented method. All
LOD concentrations will be verified.
The limit of quantitationLOQ is defined by the calibration range and is verified annually.
The IDL was performed using the lowest calibration standard and meets the method requirements
for precision and accuracy, therefore, the LOQ does not need to be confirmed. IfSince no results
are reported outside the calibration range, an LOD study is not required..
If the LOD is determined using the lowest calibration standard and meets the method
requirements for precision and accuracy, the LOQ does not need to be verified.
9.

Sample Handling

Sample Acceptance Policy

Designated employees and trained sample collectors are the only official collectors of samples.
Collection is performed using approved plastic or glass containers of sufficient volume containing
the necessary preservatives and chlorine neutralizing agents. Bacteriology samples are collected
in sterile containers. Samples that have not been properly stored during transport to the
laboratory shall not be accepted. Containers that are found at receipt to be compromised, cracked
or leaking, will not be accepted. Each sample container will be uniquely identified using a durable
(water resistant) label. For this laboratory, the field code or site ID along with the collection date,
and time will be used to mark the samples submitted. Samples that require holding at 4 oC and
which are hand delivered to the laboratory immediately after collection must be transported on ice
in order to demonstrate that the chilling process has begun. The sample acceptance policy is
available to the sample collectors. If any samples do not meet any requirements of the acceptance
policy, the samples are not accepted for testing, and re-sampling is requested. The client is
notified.
Obtaining sample aliquots from a submitted sample as part of the test method is carried out using
procedures as written in each method SOP. Appropriate techniques to obtain representative subsamples are employed and documented in the method SOP.
The samples must be submitted to the laboratory with records of field ID, location, date and time
of collection, collectors name, preservation, sample type, and remarks. Complete preservation
and handling instructions are furnished to the sample collectors.

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Summary of Sampling and Handling Requirements

Analyte
BOD
TSS
TKN
pH
Temperature
PW Total
Coliform / E.
coli
enumeration
NW Total
Coliform / E.
coli
enumeration
PW Total
Coliform / E.
coli
qualitative

Container Minimum
Sample Size
(ml)
Plastic
1000
Plastic
200
Plastic
500

Preservation
Requirements

Holding Time

Cool 1-4oC
Cool 4oC
Cool 4oC and
H2 SO4 to
pH<2
None
None
Cool 4oC
0.008%
Na2S2O3

48 hours
7days
28 days

Plastic
Plastic
Plastic

50
50
120 (100
analysis)

15 minutes
15 minutes
8 hours

Plastic

120

Cool 4oC

8 hours

Plastic

120 (100
analysis)

Cool 4oC
0.008%
Na2S2O3

30 hours

Sample Receipt Protocol - Upon receipt, the condition of the samples, including all items
specified in the sample acceptance policy, are checked and recorded. Samples with a temperature
of just above freezing to 6oC are acceptable if 4oC is specified. Samples that have not had time to
cool are acceptable if they arrive on ice and cooling has begun. Dechlorinated samples are
acceptable if the chemical test yields no free chlorine detected. Acid-preserved samples are
acceptable if test with pH paper or pH meter yields a result of <2. All exceptions to the sample
receipt protocol are fully documented.
Sample records are linked to the sample ID and include all required information specified by the
sample acceptance policy.
Samples are stored according to conditions specified in each test SOP. The laboratory has
documented procedures and appropriate facilities to avoid deterioration, contamination, or
damage to samples during storage, handling, preparation, and testing. Storage conditions are
maintained, monitored, and recorded.
Procedures for handling submitted samples
Obtaining sample aliquots from a submitted sample as part of the test method is carried out using
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procedures as written in each method SOP. Appropriate techniques to obtain representative subsamples are employed.
Each sample container will be uniquely identified using a durable label. For this laboratory, the
field code or site ID along with the collection date will be used to mark the samples submitted.
The sample acceptance policy is documented and available to the sample collectors. If any
samples do not meet any requirements of the acceptance policy, the data is flagged in an
unambiguous manner clearly defining the nature and substance of the variation.
The sample receipt protocol is documented. The condition of the sample, including any
abnormalities or departures from standard condition as prescribed in the relevant test method, is
recorded.
Receipt of all samples is recorded in a permanent chronological record, or log book. The log
book contains project name, date and time of laboratory receipt, laboratory ID, initials of
recorder.
Sample records which are also available and linked to the sample ID include all required
information specified by the sample acceptance policy.
Samples are stored according to conditions specified in each test SOP. The laboratory has
documented procedures and appropriate facilities to avoid deterioration, contamination, or
damage to samples during storage, handling, preparation, and testing. Storage conditions are
maintained, monitored, and recorded where necessary.
10.

Laboratory Environment

Testing occurs only within the laboratory. Laboratory space is maintained and monitored to the
specifications required for laboratory space and the testing performed. Electronic balances are
located away from drafts and doorways and mounted on marble slabs in areas where their use is
affected by vibrations. Biological sterility is measured using air density plates and recorded when
necessary according to the bacteriological test methods SOPs. Biological work areas are
sterilized between uses. Neighboring test areas of incompatible activities are effectively
separated. Specific work areas are defined and access is controlled. (Only authorized laboratory
personnel and escorted signed-in visitors may enter the work area.) Good housekeeping measures
are employed to avoid the possibility of contamination. Smoking is prohibited. Work areas
include: entries to the laboratory, sample receipt area, sample storage area, laboratory analysis
area, chemical and waste storage area, data handling and storage area.
All equipment and reference materials required for the accredited tests are available in the
laboratory. Records are maintained for all equipment, reference measurement materials, and
services used by the laboratory.

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Reference materials traceable to national standards of measurement or to national standard

reference materials are stored away from heavy use areas or major equipment that may effect the
proper operation of the materials. Certificates of Traceability are available for the reference
thermometer and the Class S weights. The reference materials are used only for calibration to
maintain the validity of performance.
11.

Procedures for Calibration, Verification, and Maintenance of Equipment

Equipment is maintained, inspected, and cleaned according to the written Equipment Maintenance
Procedures. Any defective item of equipment is clearly marked and taken out of service until it has
been shown to perform satisfactorily.
Each item of equipment or reference material is labeled to show its calibration status.
Equipment and reference material records include:
1.
2.
3.
4.
5.
6.
7.
8.
9.

Name of item of equipment or reference material

Manufacturer, identification, serial number
Date received and placed in service
Current location
Condition when received
Copy of manufacturers instructions or manuals
Dates and results of calibrations/verifications and date of next
calibration/verification
Details of maintenance carried out to date and planned for the future
History of any damage, malfunction, modification, or repair

Service of equipment is performed by qualified service organizations. All records and certificates
from service calls are retained.
Support equipment calibrations are verified annually using NIST traceable references over the
range of use. Balances, ovens, refrigerators, freezers, incubators, and water baths are checked
with NIST traceable references (where possible) on each day of usedaily and recorded. Additional
monitoring as prescribed by the test method SOP is recorded. Mechanical volumetric dispensing
devices are checked for accuracy quarterly and recorded. Autoclave cycles of chemical tests
(digestions) are recorded by use of chemical indicators or temperature recorder and pressure
gauge. The sterilization temperature, cycle time, and pressure of each autoclave run for biological
tests are recorded. Monthly use of spore strips to demonstrate sterilization. Autoclave tape is
only used to indicate that each batch has been exposed to the sterilization process.
12.

Verification Practices

The laboratory reports its participation in an accredited proficiency testing program for each
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category of ELAP approval semi-annually. ELAP PT studies may be used. The results are used to
evaluate the ability of the laboratory to produce accurate data. Proficiency test reports along with
all raw data necessary to reconstruct the analyses are retained at the laboratory.
The laboratory does not participate in interlaboratory comparisons.
The laboratory purchases external reference samples. All reference samples are certified. The
laboratory retains the manufacturers Certificate of Analysis.
13.

Internal Quality Control Procedures

The data acquired from quality control (QC) procedures are used to estimate the quality of
analytical data, to determine the need for corrective action, and to interpret results after corrective
actions are implemented. Each method standard operating procedure (SOP) includes detailed QC
procedures and QC limits. QC limits are generated where no method limits exist. QC limits for
laboratory control samples (LCS) and matrix spikes (MS) are based on the historical mean
recovery plus or minus three standard deviations units. Duplicate limits for precision range from
zero to 3.27 times the mean of the historical differences or relative percent differences.
(In cases where historical data is not available, interim QC limits will be used until 20 data points
are available to calculate QC limits. Interim QC limits for LCS and MS will be 80% - 120%
recovery. Interim QC limits for duplicates will be 20% relative percent difference.)
All quality control measures are assessed and evaluated on an on-going basis. Analytical data
generated with QC samples that fall within prescribed acceptance limits indicate the test method
was in control. Data generated with QC samples that fall outside QC limits indicate the test
method was out of control. These data are considered suspect and the corresponding samples are
reanalyzed or reported with qualifiers if reanalysis is not possible.
Method Blanks are performed at a frequency of one per batch of twenty or fewer samples. The
results are used to determine batch acceptance. When blanks exceed the method SOP limits, the
source of the contamination is investigated and measures are taken to correct, minimize and
eliminate the problem.
Laboratory control samples are performed at a frequency of one per batch of twenty or fewer
samples. The results are used to determine batch acceptance.
Matrix spikes are performed at a frequency of one per twenty samples. The results are used to
determine the existence of matrix effects in the spike sample. A matrix effect is indicated if the
LCS data are within QC limits but the matrix spike data exceed QC limits.
Laboratory duplicates are performed at a frequency of one per twenty samples. Duplicates are a
measure of precision. If a duplicate result falls outside QC limits the original sample and the
duplicate sample data is regarded as unreliable.
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Control of Non-Conforming Environmental Testing

Specific corrective action protocols for handling out-of control QC are in each method SOP of the
Methods Manual. In addition, general procedures are followed to determine when departures
from quality control have occurred. Provision is made for such deviations and documentation is
determined by the Corrective Action Procedure. Because of the sampling schedule and the time
frame of the analysis, it is not always possible to repeat the analysis if all quality control measures
are not found acceptable. Therefore, if a quality control measure is found to be out-of-control,
and the data is to be reported, all samples associated with the failed quality control measure are
reported with the appropriate data qualifier.
All employees have the authority to stop work on samples when any aspect of the testing and
reporting process does not conform to the laboratorys SOPs or clients requirements. The
employee who stopped work shall immediately notify the section manager, QAO, and/or TD.
The QAO evaluates the significance of the non-conforming work. Corrective action is established
for significant non-conforming work. If necessary, the client is notified and defective reports are
recalled. The TD is responsible for authorizing the resumption of work.
15.

Corrective Action Procedure

Corrective action is the process of identifying, investigating, approving, implementing and

validating measures to counter unacceptable departures from policies and procedures or out of
control QC performance which can affect data quality.
Deficiencies cited in the external assessment (such as an ELAP inspection), internal quality audits,
complaints, and managerial reviews are documented. Documentation is accomplished using the
Corrective Action Form maintained by the laboratory, and signed by the QAO and TD. The
Corrective Action form is included in Appendix C. Records shall be available to show that the
root cause(s) of the deficiencies are investigated, including the results of the investigation.
Records shall be available to document the intended corrective action. Records shall be available
to show that the implemented corrective action is monitored for effectiveness. The QAO
maintains these records. The TD will ensure that the corrective actions are discharged within the
agreed upon time frame. When non-conformances and departures from SOPs cause doubt about
the laboratorys operations, the affected areas are promptly audited.
Method SOPs provide QC acceptance criteria and specific protocols for corrective actions. Any
QC measure result that falls outside of acceptance limits requires corrective action. When testing
discrepancies are detected such as out-of-control QC, the analyst will follow the specific protocol
for corrective action as stated in the method SOP located in the Methods Manual. In addition,
any discrepancies are documented in the Corrective Action Log maintained in the laboratory. The
discrepancy will be identified, and the sample data associated with the discrepancy will be flagged.
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The QAO will recommend corrective actions to be initiated by the analyst and ensure
implementation and documentation of the corrective action. Each corrective action log entry is
reviewed, signed, and dated by the QAO and the TD. Corrective actions are performed prior to
the reporting of the effected data.
16.
Exceptionally Permitted Departures from Documented Policies and Procedures or
From Standard Specifications
The TD has responsibility for ensuring the labs policies and procedures are adhered to.
Arrangements for known and controlled departures from documented policies and procedures are
allowed. Planned departures do not require audits, however, the departure will be fully
documented by the QAO and include the reason for the departure, the effected SOP(s), the
intended results of the departure and the actual results. If the data reported to the authority or
client is affected adversely, it will be notified in writing. The corrective action procedure is used
for documenting this process.
17.

Preventive Action

Preventive action is the pro-active process to identify opportunities for improvement rather than a
reaction to the identification of problems or complaints.
All employees have the authority to recommend preventive action. Recommendations are made
to the QAO. If warranted, the QAO develops an action plan to develop, implement and monitor
the action. The plan must include controls that will enable objective evaluation of its suitability.
The preventive action is audited under the direction of the QAO.
18.

Complaints and Feedback

18.1 All complaints about the laboratorys activities received from clients or other parties will be
documented in a complaint file maintained in the laboratory. The file will contain the date and
name of the person receiving the complaint, a description of the complaint, source of the
complaint, the resolution, and any written material accompanying the complaint. The form for
Corrective Actions in Appendix C will be used for complaints.
The QAO investigates complaints and promptly audits all areas of activity and responsibility
involved. The written results of the investigation including actions taken by the laboratory are
reviewed by the TD. The results of the investigation are signed and dated by the TD and the
QAO
18.2 Feedback from clients will be solicited and recorded in a manner appropriate for the
laboratory.
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19.
Internal Audit and Data Review
Data Review
All original observations and calculations are reviewed and evaluated by the second analyst or the
QAO before it is reported. The data is reviewed, per the relevant SOPs, to ensure that
calculations are correct, including any manual integrations and to detect transcription errors. The
second analyst reviewer will sign and date the raw data on the reviewed by space. The results of
all quality control measures are reviewed and evaluated by the QAO before data are reported.
Errors detected in the review process are referred to the analyst for corrective action. The QAO
assures that all errors found in the review process are documented along with the corrective
action.
Each calendar quarter, the QAO audits 5% or 5 data packages, which ever is more. The purpose
of the review is to verify that all data integrity requirements are met.
Internal Quality System Audits
The QAO will arrange for an internal quality system review annually. The audit will be carried out
by trained personnel who are independent (if possible) of the activity being audited. The QAO will
review the requirements of the ELAP manual and NELAC standard against laboratory operations,
and laboratory operations against the laboratory Quality Manual and SOPs. The results of the
audits will be documented in writing. Where audit findings cast doubt on the validity or
correctness of the data, the lab will take immediate corrective action. Any corrective actions will
be documented. Any Authority/client whose work was possibly adversely affected shall be
notified in writing. Documented reviews are performed with respect to any evidence of
inappropriate actions or vulnerabilities related to data integrity. Allegations are confidentially
investigated. All investigations that result in findings of inappropriate activity are documented and
shall include any disciplinary actions involved, corrective actions taken, and all appropriate
notifications to clients. Documentation is maintained for five years.
Managerial Review
The TD shall review the laboratory quality system and its testing and calibration activities annually
to introduce any necessary changes or improvements. The review will take into account the
following:
the outcome of recent internal audits,
reports from managerial and supervisory personnel,
suitability of policies and procedures,
assessments by external bodies (NYSDOH or Primary Accrediting Authority, NYS
DEC, USEPA, clients),
the results of ELAP proficiency tests, if available
any changes in the volume and type of work undertaken,
feedback from clients or regulatory authorities,
corrective and preventive actions and complaints,
other factors such as quality control activities, changes in resources and staff, and staff
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training.
The findings and any corrective actions from this review will be documented. The review will be
written, cover a twelve-month period, and be signed and dated by upper management.
Documentation is to be maintained for five years.
20.

Training and Review of Personnel Qualifications

Laboratory management reviews an applicants level of qualification, experience, and skills against
the laboratorys job description requirements before assigning an employee to the laboratory. Each
analyst has adequate experience and education to demonstrate specific knowledge (include your
definition of adequate training and experience here, i.e. qualification requirements for the position)
of their function and a general knowledge of laboratory operations, test methods, QC procedures,
and records management. The TD will keep the following personnel records:
Training File
The laboratory will maintain a training file which contains:
A signed and dated statement from each employee that they have read, understood, and
are using the current version of the laboratory Quality Manual and SOPs,
Annually, a signed and dated ethics statement from each employee that they have read,
acknowledged and understood their personal ethical and legal responsibilities including
the potential punishments and penalties for improper, unethical or illegal actions,
An initial Demonstration of Capability for each employee for each accredited method,
Documentation of any training courses, seminars, and/or workshops, and
Documentation of each employees continued proficiency to perform each test method
by one of the following annually:
o acceptable performance of a blind sample (single blind to the analyst) for each
accredited method, or
o analysis of an authentic sample that has been analyzed by another trained analyst
with statistically indistinguishable results.

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Demonstration of Capability (DOC)

A DOC must be performed prior to using any test method, and any time there is a change in
instrument type, personnel, or method. The procedure will follow ELAP Certification Manual
Item 210, and the DOC Certificate included therein is completed for each analyst for each
accredited method. This laboratory, through QC charting, has historical data adequately
demonstrating analysts capability to meet the laboratory-generated acceptance criteria. Where
the analyst has demonstrated capability through analysis and QC charting of Laboratory Control
Samples with acceptable results, the procedure for demonstrating continued proficiency to
perform the test method will be used for the DOC Certification Statement.
21.

Data Integrity

Senior managers/department heads acknowledge their support of this program by upholding the
spirit and intent of the laboratorys data integrity procedures and effectively implement the specific
requirements. The Data Integrity Program consists of four parts:
21.1 Data Integrity/Ethics training
The training shall occur for each employee required to perform laboratory testing either at the
initial hiring orientation or within two weeks after assignment to laboratory functions. Annual
training is required for all experienced employees. Training may be conducted in-house or
externally. A record of training and a signed attestation by the trained employee shall be placed in
the employees training file.
Topics covered are documented in writing and provided to all trainees. Key topics covered are
the organizational mission and its relationship to the critical need for honesty and full disclosure in
all analytical reporting, how and when to report data integrity issues and record keeping. Training
includes discussion regarding all data integrity procedures, data integrity training documentation,
in-depth data monitoring and data integrity procedure documentation.
Trainees are required to understand that any infractions of the laboratory data integrity procedures
will result in a detailed investigation that could lead to very serious consequences including
immediate termination, or civil/criminal prosecution.
The initial and annual refresher data integrity training shall have a signature attendance sheet that
demonstrates all staff have participated and understand their obligation related to data
integrity/ethics. Specific examples of breaches of ethical behavior should be discussed including
improper data manipulations, adjustments of instrument time clocks, and inappropriate changes in
concentrations of standards. Data integrity training requires emphasis on the importance of
proper written narration on the part of the analyst with respect to those cases where analytical
data may be useful, but are in one sense or another partially deficient.

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21.2 Ethic Agreement

Following initial data integrity training and on-going annual training, all laboratory managers,
staff, and trainees shall sign a written ethics agreement. Senior managers who provide the training
shall also sign the agreement. The agreement states that the signers will not engage in any
unethical practices with respect to data integrity nor will they tolerate improper behavior in others
if it is observed or suspected. By signing, senior managers acknowledge their duties in upholding
the spirit and intent of the data integrity system and in effectively implementing the specific
requirements of the plan. The Code of Ethics statement agreement is included in Appendix D.
21.3 Monitoring
Monitoring of data production is accomplished by report review. Reports and the data used to
support them are randomly selected by the QAO for auditing to verify that all data integrity
requirements are met. Each calendar quarter the QAO audits 5 % or 5 data packages, which ever
is more, and documents the review (Refer to Section 19, Data Review). The QAO shall have an
in-depth understanding of typical inappropriate analytical behavior and be trained in the data
integrity system. Records of these reviews are retained for five years.
21.4 Confidentiality
Confidentiality is critical and maintained by use of locked filing cabinets and password protected
electronic files. All data integrity incidents must be documented, including investigative findings
and disciplinary actions. Corrective actions are recorded. If client disclosure is determined to be
necessary by senior laboratory management then such disclosures and outcomes are recorded.
All data integrity documents, SOPs, personal records and records of investigations shall be
maintained for a period of seven years. Documents are subject to the document control system
and records are subject to the records management system as described in the laboratorys quality
manual and related SOPs.
22.

Reporting Analytical Results

The results of each test carried out by the laboratory are reported accurately, clearly,
unambiguously, and objectively. For a treatment facility laboratory, the following information
shall be made available on request. Commercial providers of laboratory services and facility
laboratories providing services to outside clients shall include this information for the client in the
report of laboratory analysis:
1. Title;
2. Name and address of laboratory, and location where the test was carried out if
different from the address of the laboratory and phone number with name of contact
person for questions;
3. Unique identification of report and each page, including the total number of pages;
4. Name and address of client, where appropriate and project name, if applicable
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5. Description and unambiguous identification of the tested sample including the

client identification code;
6. Identification of results derived from any sample that did not meet sample
acceptance requirements, such as, improper container, holding time, or temperature;
7. Date of receipt of sample, date and time of sample collection, date(s) of
performance test, and time of sample preparation and/or analysis if the required
holding time for either activity is less than or equal to 72 hours.
8. Identification of test method used, or unambiguous description of any nonstandard method used;
9. If the laboratory collected the sample, reference to the sampling procedure;
10. Any deviations from (such as failed QC), additions to or exclusions from the test
method (such as environmental conditions), and any non-standard conditions that may
have affected the quality of the results, including the use and definitions of data
qualifiers;
11. Measurements, examinations and derived results, supported by tables, graphs,
sketches and photographs as appropriate, and any failures identified; reporting units on
a wet or dry basis;
12. When required a statement of the estimated uncertainty of the result
(radiochemistry);
13. A signature and title, or an equivalent electronic identification of the person(s)
accepting responsibility for the content of the of the report, and date of issue;
14. Clear indication of data provided by outside sources, such as subcontracted
laboratories, clients etc; and,
15. Clear identification of numerical results with values outside of quantitation limits.
Subcontracted laboratories are identified by name and/or accreditation number on the report.
If errors are detected in the report, a subsequent revised report will be issued. The updated report
will be titled Revised Report.
If the laboratory discovers equipment used to derive results in any report casts doubt on the
validity of the result it shall notify the client(s) in writing.
The test results could be expressed in terms of measurement uncertainty, if requested. To take
into account all components of variability, the standard deviation (SD) from the LCS control chart
will be used. To express a result for a 95% confidence interval, use two times the SD, for a 99%
confidence interval, use three times the SD. The confidence interval for suspended solids will be
taken from the duplicate control chart, the working (95%) or upper (99%) control limit. The
sample result could be reported: result +/- 2 X SD (95% confidence interval)
The laboratory shall, where clients require transmission of test results by telephone, telex,
facsimile or other electronic or electromagnetic means, follow documented procedures that ensure
that the above requirements are met and that confidentiality is preserved.

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Records

Analytical records include all raw data, strip charts, printouts, calculations, forms, and logbooks.
Quality records include reports from internal audits and management reviews as well as records of
corrective and preventive actions. All records are retained for at least five years. The only
exceptions areis potable water (non copper and lead) analytical records, which are to be retained
for ten years; lead and copper records must be retained for 12 years..
24.

Confidentiality and Proprietary Rights

Reports of laboratory analysis will only be released to the named contact person on the sample
submittal form or job contract. Proprietary information, if provided by the client, will be
protected as Confidential Business Information in accordance with Title 40, Code of Federal
Regulations, Part 2, Subpart B.
Government laboratory information is subject to the Freedom of Information Law. Requests for
such information are directed to the Municipal Attorney for processing.
25.

References

24.1. ISO 10725, Acceptance sampling plans and procedures for the inspection of bulk
materials, 2000.
24.2. National Environmental Laboratory Accreditation Conference (NELAC), 2003 NELAC
Standard, Approved June 5, 2003, Effective July 1, 2003, 324 pp (EPA/600/R-04/003).
24.3. National Environmental Laboratory Accreditation Conference (NELAC), 2009 NELAC
Standard, Approved August 24, 2009, Effective July 1, 2011.
24.4. New York State Department of Health (NYSDOH) Environmental Laboratory Approval
Program (ELAP), Certification Manual
(http://www.wadsworth.org/labcert/elapcert/certmanual/index.html).
24.5. New York State Department of Health (NYSDOH), 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.
24.6. Methods for Chemical Analysis of Water and Wastewater, U.S. Environmental Protection
Agency, EPA-600/4-79-020, March 1979.
24.7. Standard Methods for the Examination of Water and Wastewater, 18th Edition, APHA,
AWWA, and WEF, 1992.
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Appendix A - Organization Chart

Quality Assurance
Officer

Laboratory Director

Laboratory
Technicians /
Operators

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27.

Appendix B Master List of Documents

Doc
No.

Title

Effective
Date

Revision
No.

Quality Manual

05/20/10

pH SOP

3
4
5
6
7
8
9
10

Internal Quality Audit Outline

Data Integrity Plan/SOP
Annual Managerial Review Outline
Temperature SOP
BOD SOP
Total Suspended Solids SOP
Total Kjeldahl Nitrogen SOP
Colilert SOP

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Location
of Copy
#1

Location
of Copy
#2

QA
office

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28.
Appendix C Complaint/Corrective / Preventive Action Log
OPEN DATE:
INITIATED BY:
BASIS:
DESCRIPTION:
METHOD: ________________
Audit
Complaint
PT failure
Deficiency
QC failure
SOP
departure
sssXXXXXXXXXXXXXXXXXXXXXX
Prevention
DATA:
Type ________________
Samples ______________
_____________________
_____________________ RECORDED BY: ________________________ DATE: _________
ROOT CAUSE: / PURPOSE:

INVESTIGATED BY: ___________________________ DATE:

____________
POTENTIAL CORRECTIVE / PREVENTIVE ACTIONS:

RECOMMENDED BY: __________________________ DATE:

____________
ACTIONS PERFORMED:
DISPOSITION OF DATA:
Reanalyzed
Rejected
Qualified
Recalled
____________

PERFORMED BY: _______________________________ DATE:

FOLLOW-UP ACTIVITIES:

Continue another corrective action

Change to SOP # ___________ASSESSED BY: _______________________ DATE: ________

QA officer: ______________________________

CLO

Date: _____________

CLOSED DATE: ________________

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29.

Appendix D - Code of Ethics

1.

Conflict of interest. No employee should have any interest, financial or otherwise, direct
or indirect, or engage in any business or transaction or professional activity or incur any
obligation of any nature, which is in substantial conflict with the proper discharge of his
duties in the public interest.

2.

No employee should accept other employment which will impair his independence of
judgment in the exercise of his official duties.

3.

No employee should accept employment or engage in any business or professional activity

which will require him to disclose confidential information which he has gained by reason
of his official position or authority.

4.

No employee should disclose confidential information acquired by him in the course of his
official duties nor use such information to further his personal interests.

5.

No employee should use or attempt to use his official position to secure unwarranted
privileges or exemptions for himself or others.

6.

No employee should engage in any transaction as representative or agent of the

government with any business entity in which he has a direct or indirect financial interest
that might reasonably tend to conflict with the proper discharges of his official duties.

7.

An employee should not by his conduct give reasonable basis for the impression that any
person can improperly influence him or unduly enjoy his favor in the performance of his
official duties, or that he is affected by kinship, rank, position or influence of any party or
person.

8.

An employee should abstain from making personal investments in enterprises which he has
reason to believe may be directly involved in decisions to be made by him or which will
otherwise create substantial conflict between his duty in the public interest and his private
interest.

9.

An employee should endeavor to pursue a course of conduct which will not raise
suspicion among the public that he is likely to be engaged in acts that are in violation of his
trust.

10.

No employee employed on a full time basis nor any firm or association of which such an
employee is a member nor corporation a substantial portion of the stock of which is
owned or controlled directly or indirectly by such an employee, should sell goods or
services to any person, firm, corporation or association which is licensed or whose rates
are fixed by the agency in which such an employee serves.
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11.

If any employee shall have a financial interest, direct or indirect, having a value of ten
thousand dollars or more in any activity which is subject to the jurisdiction of a regulatory
agency, he should file a written statement that he has such a financial interest in such
activity which statement shall be open to public inspection.

12.

Violations
In addition to any penalty contained in any other provision of law any such employee who
shall knowingly and intentionally violate any of the provisions of this Code of Ethics may
be fined, suspended or removed from office or employment in the manner provided by law.

The following laboratory staff members have read this Code of Ethics. I certify that the
requirements of this Code of Ethics have been communicated to me and that I am trained in its
use. A copy of this page will be distributed to the employee training record file. I will not engage
in any activities that could possibly negatively impact the integrity of data produced in this
organization.
_______________________ ________________________
Signature
Name

_______
Date

_______________________ ________________________
Signature
Name

_______
Date

_______________________ ________________________
Signature
Name

_______
Date

_______________________ ________________________
Signature
Name

_______
Date

_______________________ ________________________
Signature
Name

_______
Date

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