Project Integration, Inc.

1097 Highway 101 South Suite D16 Greer, SC 29651

864-334-5085

sales@pintegration.com

John Deere

Des Moines, Iowa

Quality Assurance Project Plan (QAPP) For Delisting of F006 

and F019 Sludge Filter Cake

June 2012
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Table of Contents

Introduction............................................................................................................................................................... iii

1. Project Description..........................................................................................................................................1

1.1 Overview...............................................................................................................................................1

1.2 Sampling Strategy................................................................................................................................1

2. Project Organization and Responsibility .....................................................................................................2

2.1 Project Director.....................................................................................................................................2

2.2 Quality Assurance Officer..................................................................................................................2

2.3 Health and Safety Coordinator..........................................................................................................2

2.4 Laboratory Personnel ..........................................................................................................................2

3. Quality Assurance Objectives for Measurement Data ...............................................................................3

3.1 Precision................................................................................................................................................4

3.2 Accuracy................................................................................................................................................4

3.3 Completeness .......................................................................................................................................4

3.4 Representativeness ..............................................................................................................................5

3.5 Comparability.......................................................................................................................................5

4. Sampling Procedures ......................................................................................................................................6

4.1 General Documentation Requirements ............................................................................................6

4.2 Sampling ...............................................................................................................................................7

4.3 Sample Preparation and Handling....................................................................................................7

4.3.1 Sample Containers and Cleaning Requirements...............................................................7

4.3.2 Sample Preservation and Holding Times...........................................................................7

4.3.3 Sample Labeling and Handling...........................................................................................7

4.4 Documentation.....................................................................................................................................8

5. Sample Custody...............................................................................................................................................9

5.1 Field Procedures ..................................................................................................................................9

5.2 Laboratory Procedures......................................................................................................................10

6. Calibration Procedures .................................................................................................................................11

7. Analytical Procedures...................................................................................................................................12

8. Data Reduction, Validation, and Reporting ..............................................................................................13

8.1 Data Reduction...................................................................................................................................13

8.2 Data Validation and Assessment.....................................................................................................13

8.2.1 Field Blanks ..........................................................................................................................14
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8.2.2 Holding Time .......................................................................................................................14

8.3 Data Reporting ...................................................................................................................................14

8.3.1 Qualifiers ..............................................................................................................................14

8.3.2 Data Reporting System .......................................................................................................14

8.4 QA Data Validation Summary Report............................................................................................15

9. Quality Control..............................................................................................................................................16

9.1 Field Duplicate Samples ...................................................................................................................16

9.2 Field Blanks ........................................................................................................................................16

10. Audits .............................................................................................................................................................16

10.1 Field Operations Audit .....................................................................................................................16

10.2 Audit Procedures ...............................................................................................................................17

11. Preventive Maintenance ...............................................................................................................................18

12. Specific Routine Procedures Used to Assess Data Precision, Accuracy, and Completeness..............19

13. Nonconformance/Corrective Action...........................................................................................................20

13.1 Nonconformance................................................................................................................................20

13.2 Corrective Action...............................................................................................................................20

14. Quality Assurance Reports to Management..............................................................................................22

14.1 Measurement Data Reports ..............................................................................................................22

14.2 Reports of Significant QA Problems and Recommended Solutions ...........................................22

Appendices

Appendix A: Laboratory System Quality Manual
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Introduction

This Quality Assurance Project Plan (QAPP) has been prepared to support the Sampling and Analysis Plan 

(SAP) for the delisting of F006 and F019 sludge filter cake at the John Deere facility in Des Moines, Iowa. The 

purpose of this plan is to specify the data quality objectives, sample collection procedures, data analysis 

procedures, and general project procedures such that the objectives of the SAP are achieved. In accordance 

with the SAP, this plan is designed to comply with the following:

• Section 10 of the USEPA publication, “Test Methods for Evaluating Solid Waste,” third edition (or as 

updated) (SW-846);

• “EPA Requirements for Quality Assurance Project Plans” (EPA QQ-R5); and

• EPA Region 6 Delisting Program Guidance Manual for the Petitioner, March 1996.

The change with this revision is to incorporate the delisting for F019 hazardous waste into the delisting plan.
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1. Project Description

1.1 Overview

A sampling and analysis plan has been developed for the purpose of characterizing sludge filter cake from 

the wastewater treatment system of the John Deere facility in Des Moines, Iowa. The results of this 

investigation will be used to determine if this RCRA-listed waste (F006) can be delisted. This can be 

determined by demonstrating that this waste: 1- does not exhibit any of the criteria for which it was listed; 

2- does not exhibit any other factors (including additional constituents) that could cause it to be hazardous; 

3- will not contribute to the contamination of ground water; and 4- does not pose any other threat to human 

health or the environment.

John Deere produces a dewatered sludge filter cake generated from wastewater treatment plant filter press. 

John Deere treats wastewater associated with an electroplating process, therefore the resultant filter cake 

from the wastewater treatment process is a listed hazardous waste according to RCRA (40 CFR 261.31). The 

F006 and F019 filter cake drops from a filter press into a 25 cubic yard roll-off container. The filter cake is a 

reddish-brown solid (approximately 40% solids) and has a density of approximately 80 to 85 pounds per 

cubic foot. The filter cake contains metal hydroxides.

The John Deere facility operates on a continuous basis (24 hours per day, 7 days per week). Wastewater 

from applicable processes and operations (e.g., washing, cleaning, painting, plating) flows to the WWTP 

continuously. The facility produces limited types of agricultural equipment with similar operations with 

limited changes throughout the year and over time. As a result, there is limited potential for variability from 

the incoming wastewater stream over time.

The WWTP treats and discharges approximately 110,000 gallons of wastewater per day. Typical filter cake 

produced includes two cycles per day for one or two days per week. The filter cake container will hold filter 

cake from about 12 treatment cycles and takes 2 to 3 weeks to fill. 

1.2 Sampling Strategy

Table 1 of the Sampling and Analysis Plan identifies all raw materials used at the plant. Based on 

knowledge of raw materials as well as historical data on the sludge filter cake, a sampling strategy to be 

implemented for the purposes of this assessment is shown in Table 2 of the Sampling and Analysis Plan.
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2. Project Organization and Responsibility

Sampling activities will be initially performed by MWH Americas, Inc (MWH). MWH will train the John 

Deere staff on the sampling methodology and the John Deere staff will take over sampling after the initial 

sample collection. The following are definitions of the responsibilities of the key project personnel:

2.1 Project Director

The project director will be responsible for all aspects of the project including overall quality assurance, 

technical, administrative, and budgeting objectives. The Project Director will also coordinate the interaction 

between the Task Managers that project deliverables and the project schedules are being met.

2.2 Quality Assurance Officer

The Quality Assurance Officer (QAO) will be responsible for the following:

• Administration of the project QAPP

• Day-to-day supervision of quality assurance

• Notification of personnel of nonconformances and changes in quality assurance procedures

• Determination of audit schedules

The QAO will provide the necessary guidance and audits. The QAO has the authority and freedom to 

identify quality problems; to initiate, recommend, or provide corrective actions; to verify the implementation 

of the corrective actions; and will initiate project audits, as required for the project.

2.3 Health and Safety Coordinator

The Health and Safety Coordinator is responsible for the development and implementation of the Health 

and Safety Program, as applicable to this project.

2.4 Laboratory Personnel

The key laboratory personnel for this project will be the Laboratory Director and the Laboratory Quality 

Assurance Manager. The analytical laboratory Technical Director will be responsible for execution of the 

analytical testing program for this project. John Deere has selected Test America of Chicago, located at 2417 

Bond Street University Park, Illinois 60484 to conduct the sample analysis. A copy of laboratory 

qualification, capabilities, and certifications are included with their Laboratory System Quality Manual in 

Appendix A. (electronic copy enclosed).
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3. Quality Assurance Objectives for Measurement Data

The overall QA objective for the sampling and analysis program is to provide procedures which, when 

followed properly, will result in laboratory and field data generated during this investigation that are 

technically sound, statistically valid, and properly documented in order to demonstrate that the John Deere 

filter cake does not meet the hazardous characteristic for which it has been listed. Specific procedures to be 

utilized for sampling, laboratory analyses, data reporting, and data validation, are presented in other 

sections of the QAPP. The primary purpose of this section is to define statistical acceptance criteria for 

chemical data generated by the analytical laboratory.

A primary component of data quality is selection of the appropriate quality assurance (QA) objective levels 

for the intended data use. QA levels, as described in “Data Quality Objectives for Remedial Response 

Activities (EPA, March 1987) are as follows:

• Level I – Field screening or analysis using portable instruments. Results are often not compoundspecific and not quantitative, but are available in real-time.

• Level II – Field analysis using more sophisticated portable analytical instruments; in some cases, the 

instruments may be set up in a mobile laboratory on site. There is a wide range in the quality of the 

data that can be generated that is dependent on the use of suitable calibration standards, reference 

materials and sample preparation equipment. Results are available in real-time or several hours.

• Level III – Analyses are performed in an off-site analytical laboratory. Level III analyses may or may 

not use Contract Laboratory Program (CLP) procedures. The validation or documentation 

procedures required of CLP Level IV analyses are not required or are provided in a summary type 

format.

• Level IV – CLP routine analytical services. Analyses are performed in an off-site CLP analytical 

laboratory following CLP protocols. Level IV is characterized by rigorous QA/QC protocols and 

documentation.

Data collected as described in the SAP will be consistent with the Level III DQOs. The quality of data 

generated for this sampling program characterized in terms of precision, accuracy, completeness, 

representativeness, and comparability. Further discussion on the specific routine procedures used to 

document data precision, accuracy, and completeness are presented later in this QAPP. These data 

characteristics are defined in the following subsections.
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3.1 Precision

Precision is defined as a measure of mutual agreement among individual measurements of the same 

property, usually under prescribed conditions. Precision evaluation indicated whether the reproductibility 

of the analytical result is compromised due to analytical techniques, sample matrix interferences, or other 

factors.

Precision expected for the laboratory results is addressed in the discussion of analytical uncertainty below.

3.2 Accuracy

Accuracy is defined as the degree of agreement of a measurement (or an average of measurements of the 

same thing) with an accepted true value, usually expressed as:

• The difference between two values,

• The difference relative to the reference or true value, or

• The ratio of the difference to the reference or true value

For the analytical uncertainty associated with the TCLP metals analyses, the greatest uncertainty is expected 

with the Matrix Spike (MS) recoveries. Other uncertainties, such as lab control samples and internal process 

check samples such as initial and continuing calibrations (ICV/CCV) are tighter than the MS/MSDs due to 

their absence of potential interference. The following control limits have been established for Metals.

Matrix Spike Recovery: 75% - 125%

Lab Control Sample Recovery: 80% - 120%

ICV/CCV: 90% - 110% (Initial and Continuing Calibration)

The widest uncertainty will be associated with the MS at +/- 25% of the true value. Given the TCLP waste 

criteria limits, and the sensitivity of the instrument, the laboratory is expected to generate reporting limits 

well within the TCLP metals limits.

For the organics, low recoveries for MS and other internal matrix control compounds are more common, and 

therefore the control limits are wider depending on the compound. However, the samples will be analyzed 

for both Total and TCLP constituents which will furnish an additional check on results by using the 20-times 

rule of dilution from the Total to TCLP (even with low MS recoveries).

3.3 Completeness

Completeness is defined as a measure of the amount of valid data obtained from a measurement system 

compared to the amount that was expected under normal conditions. To determine completeness, the 
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percentage of valid (i.e., acceptable) data obtained, as judged by the precision and accuracy objectives, is 

compared to the total amount to data collection, resulting in a validation percent.

Valid data are expected to exceed 90% of the collected data for the testing program. 

3.4 Representativeness

Representativeness expresses the degree to which data accurately and precisely represent a measured 

characteristic of a population, parameter variations at the sampling point, a process condition, or an 

environmental condition.

The degree of representativeness is dependent upon the objectives of the measurement results. Thus, 

representativeness can be classified into the following four “objective levels”:

• Level 1 – Only representative of the point of sampling.

• Level 2 – Sample is part of a set and represents a defined area or portion of land or water – not just 

the point of sampling.

• Level 3 – Sample represents a relationship between the source of contamination and the location 

sampled.

• Level 4 – Nonrepresentative sample – the sample is used for assessment purposes only.

The project data are intended to demonstrate that the samples are representative of the Filter Cake from the 

wastewater treatment facility filter press. This is classified as the Level 3 standard. The sampling method is 

discussed in the Sampling and Analysis Plan.

3.5 Comparability

Comparability of the data to be collected during the assessment will be achievable. For this project, 

measurement data generally will be calculated and reported in units consistent with the USEPA CLP 

protocols and standard practice to allow comparability of data already collected with any new data. In 

addition, the data will be compared to RCRA hazardous waste toxicity characteristic concentrations as 

defined in 40 CFR 261 and those calculated using the USEPA Composite Model for Landfills (CML).
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4. Sampling Procedures

The sampling and analysis program has been designed to meet the specific objectives identified in Section 

3.0. The discussion in this section includes general documentation requirements as well as specific data 

forms required for the various types of samples. Sample preparation and handling are addressed, as well as 

decontamination of sampling equipment. Sample locations are described in the Sampling and Analysis Plan 

for Delisting of F006 and F019 Sludge Filter Cake.

4.1 General Documentation Requirements

For each day during which samples are collected, a Field Activity Daily Log will be completed by the field 

staff. It will be the responsibility of the Project Director to verify that this record is completed. Information 

to be provided on the log includes, as appropriate:

• Field activity subject;

• General work activity;

• Unusual events;

• Changes to plans and specifications; and,

• Field reagents used.

The Field Activity Data Log will be signed by the individual who prepares it. Field Activity Daily Logs will 

be submitted on a weekly basis to the Project Director. Following review, the logs will be placed in the 

project file.

A photographic record of site operations will be prepared. Photographs of the following may be obtained:

• General site layout;

• Waste stream generation point;

• Sampling;

• Health and safety monitoring, if applicable; and

• Other items of interest.
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Photographs will be identified with the project number, date, and a brief description. The photographs will 

be placed in the project file.

Other data forms used for documenting sample data and field tests are described in the subsections which 

follow: Chain-of-custody documentation is described in Section 5.0.

4.2 Sampling

Sampling will be completed in accordance with the procedures and protocols specified in the Sampling and 

Analysis Plan for delisting of F006 and F019 Filter Cake.

4.3 Sample Preparation and Handling

4.3.1 Sample Containers and Cleaning Requirements

Sample containers will be supplied by the analytical laboratory such that sufficient sample volume is 

obtained for laboratory analysis and associated laboratory QA/QC procedures. The containers which will be 

used for various sample types and analyses are indicated in Appendix A, Section 6. Lot numbers of the 

containers will be recorded by the analytical laboratory.

4.3.2 Sample Preservation and Holding Times

Since certain constituents can change chemically with time, it will be necessary to preserve individual 

samples to maintain the integrity of time-dependent constituents. The preservation requirements for various 

types of samples are indicated in Appendix A, Section 6.

Preservation includes maintaining the samples in chilled conditions (4o C) once they have been obtained.

The maximum recommended holding time for properly preserved samples are provided in Appendix A. All 

samples will require storage at 4o C prior to analysis to prevent dehydration. The laboratory analysis will be 

performed within specified holding times to allow the validity of the analytical results.

4.3.3 Sample Labeling and Handling

Sample containers will have blank labels, as supplied by the laboratory. The labels will be filled out at the 

time of sample collection by the field personnel performing the sampling. Information marked on the label 

will include:

• Sample Identification Number;

• Collector’s Name;

• Date of Collection;

• Type of Sample
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• Preservatives Used;

• Analysis to be performed; and,

• Number of Bottles in Sample Set.

Samples will be transported to the laboratory in durable, secured metal or plastic coolers or laboratorysupplied, secured waterproof metal or plastic containers. Containers will be shipped via common overnight 

carrier or hand-carried within 24 hours of collection. Chain-of-custody documentation (Section 5.0) will 

accompany the samples.

4.4 Documentation

Decontamination of equipment used for sampling will be carefully performed to minimize any possibility of 

cross contamination through the use of tools and equipment. Sampling equipment that is not disposable will 

be decontaminated prior to initial use in accordance with the details specified in the Sampling and Analysis 

Plan for Delisting of F006 and F019 Filter Cake.
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5. Sample Custody

5.1 Field Procedures

A chain-of-custody record will be established and maintained to document sample possession from the time 

of collection to delivery to the laboratory. Once samples are received by the laboratory, they will be handled 

under the laboratory internal chain-of-custody procedures. Personnel obtaining samples in the field will 

initiate a chain-of-custody record by reporting the following minimum data as the samples are collected:

• Name of Sampler;

• Sample Identification;

• Data and Time Collected;

• Amount Collected; and

• Containers Used.

Other information such as preservatives used and analyses required shall be indicated as appropriate. 

Sample chain of custody forms will be placed in waterproof bags and taped to the underside of the cooler 

lids. In addition to the chain of custody record, a sample-collection form will be completed at the time of the 

sampling to record sample location and other parameters associated with sample acquisition.

Subsequently, at each change of possession, the chain-of-custody record will be signed by the person 

relinquishing the samples and the person receiving the samples. This could occur as the samples are 

transported to the laboratory, or when the samples are received at the analytical laboratory.

Once the sample containers have been filed and labeled, custody seals will be placed around each individual 

sample container and cap, so that any disturbance to the sample prior to analysis can be detected. Samples 

will then be carefully packed in coolers made of waterproof metal or plastic. Cushioning material such as 

vermiculite will be added to the cooler to prevent breakage. Sufficient amounts of ice packs will be added to 

maintain a sample temperature of 4oC. The shipping container (e.g., cooler, Styrofoam box) will be sealed 

with custody seals. At a minimum, a custody seal will be placed on the diagonal corners of the container lid 

to seal the lid to the main portion of the shipping container. Depending upon the shipping container, 

additional custody seals will be used as necessary to prevent unnoticed tampering with the samples. 

Coolers will be secured with nylon or fiber strapping tape in addition to custody seals and will be shipped 

within 24 hours of collection via an overnight carrier service.
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If samples on a chain-of-custody record are split and sent to separate destinations, multiple copies of the 

records will be generated with a clear indication of which sample went to which destination.

When the samples are received at the analytical laboratory, the person receiving the samples will note the 

condition of the custody seals found on both the coolers and sample containers. The person assuming 

custody of the samples will do so by signing the chain of custody record after accounting for all samples 

indicated on the record. At this point, the chain-of-custody records will be placed in the laboratory project 

file and copies will be transmitted to the Project Director.

5.2 Laboratory Procedures

The laboratory will designate a sample custodian for the project. This individual will be authorized to sign 

chain-of-custody records upon sample receipt and will be responsible for verifying that the custody seals are 

intact.

The project samples will be stored at the laboratory for a period of time related to they type and nature of the 

samples. Maximum laboratory holding times for various parameters are provided in Appendix A. When 

the storage times have expired, the laboratory will dispose of the samples in accordance with applicable 

regulations.
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6. Calibration Procedures

Calibration procedures which will be followed for sample analysis are discussed in Appendix A, Laboratory 

System Quality Manual. Calibration information is recorded in a laboratory log book. The laboratory’s 

calibration procedures for the analytes of interest are included in Appendix A.

.
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7. Analytical Procedures

Laboratory analysis will be completed in accordance with United States Environmental Protection Agency 

Test Methods for Evaluating Solid Waste (SW-846, most recent revision). Table 3 of the Sampling and 

Analysis Plan for Delisting of F006 and F019 Filter Cake lists the analytical methods to be followed in 

evaluating the sludge filter cake. Changes in methodology due to higher or lower than anticipated 

concentrations being detected may change the preparation or analytical method use.
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8. Data Reduction, Validation, and Reporting

8.1 Data Reduction

The analytical laboratory will utilize computer software to calculate sample concentrations for many 

parameters. A response factor or standard curve will be generated from the calibration standards and 

applied to, the absorbance, peak height, or area measured by the laboratory instrument to calculate the 

sample concentration. This value will be corrected for any dilutions or other preparations. Calculations that 

are not performed by computer programs will be performed manually by the analyst. The analyst will 

employ the same methodology used in the computer software. Corrections for dilutions and other 

preparations will be done manually. The data reduction methods are described in Appendix A.

8.2 Data Validation and Assessment

The primary objective of this project is to provide data of sufficient quality for making quantitative 

determinations that demonstrate that the John Deere sludge filter cake does not exhibit the hazardous 

characteristic for which it has been listed. It is anticipated that by using USEPA SW-846 procedures the 

laboratory will provide reliable and acceptable data to adequately characterize the John Deere sludge filter 

cake.

The analytical laboratory will perform review of the data prior to submittal to John Deere. After the 

laboratory review, validation of the sample results, independent of the laboratory, will be conducted. 

Guidelines described in USEPA Standard Operating Procedures, in the reference methods, CLP guidelines, 

and this plan will be used in the results validation by the laboratory.

The USEPA Standard Operating Procedure which will be utilized in the data validation is SOP No. HW-2, 

Evaluation of Metals Data for the Contract Laboratory Program, Revision 13, (9/06).

The laboratory will provide John Deere with a data summary package that will contain the following 

information when applicable:

• Analytical results,

• Initial and continuing calibration verification results;

• Laboratory control sample results,

• Method and field blank results,
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• Duplicate sample analysis,

• Spike sample analysis, and

• Holding times

The information in the data summary package will be used by an independent consultant to validate the 

results. A detailed description of the data summary package is provided in Appendix A.

8.2.1 Field Blanks

In the validation process, field QC practices consisting of trip blanks and equipment blanks will also be 

reviewed. Due to the complexity of environmental samples, no formal evaluation procedures can be 

established for reviewing field QC, and only subjective guidelines are provided in this section. The objective 

of field QC will be to monitor the performance of the field and laboratory personnel. Field blanks (trip and 

equipment) will be used to monitor for contamination introduced by sampling personnel, although 

laboratory-introduced contamination will also be indicated.

Except in the case of gross errors, field blanks will not be the basis of acceptance or rejection of data, but 

rather will serve as additional information for evaluation of the data.

8.2.2 Holding Time

The holding time of samples (time of collection to time of sample preparation and analysis) will be reviewed 

to verify compliance with CLP requirements. If holding time is exceeded, the sample will be flagged as 

“estimated” in accordance with CLP guidelines.

8.3 Data Reporting

The analytical laboratory will follow CLP procedures for reporting compounds. In general, soil sample data 

will be reported on the basis in which it was disposed. Concentrations will be reported in accordance with 

the reference method. Reported concentrations will not be corrected for contaminants found in associated 

blanks.

8.3.1 Qualifiers

The analytical laboratory will use CLP-defined qualifiers in reporting data.

8.3.2 Data Reporting System

Sample data will be entered into a computerized sample data management system starting when the 

samples are received by the laboratory (Section 6.0). After analysis, results will be entered into the system by 

a chemist or technician. The laboratory data reporting system is described in Appendix A.
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John Deere will receive the sample results and a summary of the associated QC data. The QC data received 

will include results for method blanks, duplicates, matrix spike recovery, and surrogate recovery. After the 

data are validated the results will be reported in accordance with the guidelines previously discussed.

8.4 QA Data Validation Summary Report

A QA Data Validation Summary Report will be prepared after the assessment is complete. This report will 

summarize QC data. Performance and system audits, significant QC problems encountered and corrective 

action taken, and QAPP modifications will be reported in the QA Data Validation Summary Report.

QA/QC values calculated by the laboratory will be compared to acceptable ranges in the data validation 

guidance. 
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9. Quality Control

A quality control (QC) program will be implemented so that consistent results of known and documented 

quality can be obtained. Laboratory quality control measures are described in Appendix A. Laboratory QC 

procedures which will be used for this project include:

• Initial calibration and calibration verification

• Laboratory Control Samples

• Matrix spikes analysis

• Duplicate analysis

• Method blanks

• ICP interference check sample

The above listed procedures are described in Appendix A.

9.1 Field Duplicate Samples

A field duplicate sample is a sample prepared by dividing a sample into two aliquots. Duplicate samples 

will be handled as individual samples. The laboratory will not be made aware that a sample is a duplicate 

sample.

9.2 Field Blanks

Field blanks are aliquots of analyte-free water brought to the field in sealed containers and transported back 

to the laboratory with the sample containers. Equipment blanks are a check on sampling device cleanliness 

and will be used for this project. Equipment blanks will be opened in the field and the contents will be 

poured over the sampling mixing bowls (disposable scoops will be used to collect the samples, and not 

reused; therefore their cleanliness is not an issue and returned to the laboratory as a sample). Sufficient 

water will be taken to the field so that the equipment blank sample container is completely filled. The 

equipment blank will be handled in the same manner as the other samples, including to 4oC.

10. Audits

10.1 Field Operations Audit

A field operations audit will be conducted during initial sampling/field activities to verify that sampling 

procedures are correctly followed. The field operations audit will involve an on-site visit by the Quality 
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Assurance Officer or designated representative. Items to be examined may, as appropriate, include the 

following: availability and implementation of approved work procedures; calibration and operation 

equipment; labeling, packaging storage, and shipping of sample obtained; performance of documentation 

and checking; subcontractor performance; and variance documentation.

10.2 Audit Procedures

Audits will be performed on the basis of a written checklist prepared prior to the audit. The checklist shall 

be developed to allow the review of necessary items and to document the results of the audit. During the 

audit and upon its completion, the auditor will discuss any findings with the individuals audited and will 

cite corrective actions to be initiated.
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11. Preventive Maintenance

The analytical laboratory will keep instrument log books which document maintenance schedules, dates, 

maintenance performed, and details of each maintenance action. Routine maintenance will be performed by 

laboratory personnel in accordance with manufacturer recommendations. Service agreements and 

preventative maintenance contracts are routinely secured by the laboratory for all critical instruments and 

equipment. These agreements provide for regular checks by qualified service personnel. Critical spare parts 

are maintained in accordance with manufacturer recommendations.
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12. Specific Routine Procedures Used to Assess Data 

Precision, Accuracy, and Completeness

Precision and accuracy for this project will be assessed through the analysis of duplicates, laboratory control 

samples, and spike samples. The Laboratory System Quality Manual (Appendix A) summarizes the QC 

analyses including precision, accuracy and completeness of data.
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13. Nonconformance/Corrective Action

13.1 Nonconformance

Nonconforming items and activities are those which do not meet the project requirements specified in the 

Quality Assurance Project Plan. Nonconformances may be detected and identified by:

• Project Staff

During investigation and testing, supervision of subcontractors, and preparation and verification of 

analyses

• Laboratory Staff

During analysis, internal quality control, and data validation activities

• Quality Assurance Officer

As the result of audits and other quality assurance activities

Each nonconformance shall be documented by the personnel identifying or originating it. Documentation 

will, as appropriate, include:

• Identification of the individual(s) identifying or originating the nonconformance.

• Description of the nonconformance

• Method(s) for correcting the nonconformance (corrective action) or description of the variance 

granted.

• Schedule for completing corrective action.

The nonconformance documentation shall be submitted to the John Deere Project Director, who will be 

responsible for notification of other staff and regulatory agencies, as appropriate.

13.2 Corrective Action

Corrective actions pertaining to field activities will be defined when specific nonconformances are identified 

and documented. 

Corrective actions pertaining to analytical procedures are directly related to the calibration, internal quality 

control, and data validation.
John Deere, Des Moines IA

Revised June 2012

Project Integration, Inc.

QAPP Project No. 101004C1 21

John Deere

The authority to implement planned corrective action when nonconformances are detected or control limits 

are exceeded rests with the Project Director for field and overall project operations and with the Laboratory 

Quality Assurance Manager for laboratory operations.
John Deere, Des Moines IA

Revised June 2012

Project Integration, Inc.

QAPP Project No. 101004C1 22

John Deere

14. Quality Assurance Reports to Management

Reports detailing the results of audits and the performance of data measurement systems will be submitted 

to Project Director. These results will include:

• Assessments of measurement data accuracy, precision, and completeness

• Results of system audits

• Results of performance audits

• Significant QA problems and recommended solutions

A description of these reports is provided in the following paragraphs.

14.1 Measurement Data Reports

An assessment of measurement data precision, accuracy and completeness will be summarized in a report. 

This report will be prepared by the analytical Laboratory Quality Assurance Manager and will be submitted 

to the Project Director. At the completion of the project, the results of previous reports will be summarized 

in a final report.

14.2 Reports of Significant QA Problems and Recommended Solutions

Significant quality assurance problems will be documented as finding in audit reports. Any such findings 

will require written documentation and solutions from the Project Director and the Quality Assurance 

Officer.