QA Program - Document Control
Our document control program at CompuChem encompasses all written documents, including
SOPs, Quality Plans, laboratory logbooks, and all data deliverables. This program
has passed numerous federal and state government inspections and examinations by
commercial clients. The control of data deliverables consists of electronic and
hardcopy data custody procedures and documentation. Our document control program
is a complete system; we have specific procedures for producing, distributing, completing,
and archiving all technical documentation.
The control of all other written records, including SOPs, Quality Manuals, personnel
qualification records, computer and safety manuals, and laboratory logbooks, is
enforced and managed by the QA Department.
The document control systems in place at CompuChem include:
- Electronic and hardcopy training documentation system
- LogTrax laboratory logbook tracking system
- Employee orientation documentation system
- SOP documentation and archival systems
- Quality Manual revision and distribution system
At CompuChem we take pride not only in the quality of our documentation, but also
in the systems we have built to protect and enhance that quality.
Standard Operating Procedures (SOPs)
CompuChem maintains Standard Operating Procedures (SOPs) that accurately reflect
laboratory activities such as assessing data integrity, corrective actions, handling
customer complaints, and all test methods. Procedures for test methods describing
how the analyses are performed are specified in analytical SOPs and include sample
preparation, cleanup and analysis. These are based on referenced methods published
primarily by the EPA. Internally developed methods will be validated according to
the EPA Performance-Based Measurement System. Controlled copies of SOPs are accessible
to all personnel in each laboratory area as well as on CompuChem's internal network.
Each SOP indicates the effective date, revision number, and signatures of the person
who initiates the revision and those who approve the revision.
SOPs are useful in training staff, in ensuring consistency among staff, and in saving
time and effort. Any deviation from an established procedure during an analysis
is documented.
Logbooks/Worksheets
The QA Specialist has primary responsibility for document and distribution control
of over 100 logbooks used in the laboratory. To ensure document uniformity and compliance
with NELAC standards, the U.S. EPA, good laboratory practices, and other certifying
agency protocols, specific document control procedures are used for all laboratory
logbooks, runlogs, and worksheets.
Document Control of Logbooks and Worksheets
Document control header information appears along the top of each logbook and identifies
the laboratory or administrative area, the logbook, and the issue number. Each logbook
issue is consecutively paginated and permanently bound.
A logbook is developed cooperatively by the area manager and the QA department.
The requestor submits a completed Logbook Request Form to the QA department. They
confer to design a prototype logbook page that meets the needs of the laboratory
and contains the key elements required by the QA department. These elements are:
- The identity of the task
- The name CompuChem, a Division of Liberty Analytical Corporation
- A "Reviewed by" signature field
- A date of review field
- Any applicable measurement acceptance ranges with instructions for reporting out-of
range readings
- A corrective action statement
- Model specifications for equipment
- Reagent manufacturer and lot number fields
The QA Specialist assigns an alphanumeric identifier to the logbook and produces
the issue that contains 150 pages. The laboratory notifies QA when the logbook is
ready for archival. Before turning over the logbook issue to QA, the manager of
the area in which the logbook is used or a designee must review the contents of
the logbook. When approved, the Logbook Authorization form, which is the last bound
page, is signed.
When completed, the laboratory returns the logbook to QA for archival. The QA Specialist
notes on the original Logbook Request Form the date of archival. The issue is then
logged into the Logbook Archival Log.
The QA department also maintains laboratory sample preparation worksheets which
include the same elements as logbooks. These are not bound nor paginated for ease
in photocopying for data reports. When completed the sample preparation staff file
them by preparation date and later paginate and bind them for archival. Revision
dates are entered onto the bottom corner of the sheet. Logbook pages are included
as attachments in SOPs.
Records Retention and Purging
Archived logbooks and laboratory records are stored on site for a period of five
years. Logbook purging is recorded in the Archived Logbook Purge Log.
QA Program - System/Performance Audits
Our QA department staff performs a host of internal system and performance audits
to ensure that data quality objectives are met. In addition, our laboratory undergoes
routine inspections by external auditors. These internal and external audits encompass:
- Good laboratory practices (glp)
- Training procedures and records
- General record keeping
- Document control
- Data storage and retrieval
- Sample storage and chain-of-custody (COC) procedures
- SOP compliance
- Reagent storage and control
Standards preparation and traceability Data audits Good automated laboratory practices
(GALPs) Performance evaluation samples The QA department summarizes results of all
audits and reports these to laboratory management. Corrective actions are taken
when necessary and such actions are carefully documented.
System Audits
System audits are performed both by internal and external auditors. Clients and
federal and state certifying agencies perform external system audits. A system audit
is performed to qualitatively assess the laboratory's control systems and is intended
to provide evidence of the laboratory's competence.
The objectives of a system audit include ensuring that:
- management is committed to creating a work environment dedicated to quality and
that a structured management system is in place to support an effective QA program,
- the QA program is documented and implemented to assess work to ensure technical,
administrative, and quality objectives,
- personnel are adequately trained and qualified to do their jobs, procured items
and services meet established requirements and perform adequately,
- procedures are established and maintained for the timely preparation, issuance,
control, and revision of documents, including documentation of review and approval,
and that records are specified, prepared, reviewed, approved, and maintained for
evidentiary purposes,
- computer hardware meets requirements and that any changes are controlled; computer
software is developed, validated, verified, and documented; and that any changes
are controlled
- work performed complies with established technical standards and administrative
controls, as well as safety policies, and
- procedures are established for detecting and preventing quality problems and for
ensuring quality improvement.
QA Program - Method Validation
CompuChem validates all analytical methods before they become analytical services
to our clients. To validate a method, one of our senior chemists reviews the published
method description, assessing the instrumentation needed to perform the method,
the QA/QC requirements, and any potential safety hazards. Based on his/her review,
the chemist formulates a plan of testing and submits this plan to laboratory management
for approval. If the chemist's proposal is approved, a full-scale method validation
study is performed. All method validation studies must include:
- a method detection limit (MDL) determination (repeated annually)
- a precision and
accuracy determination
Once the method validation study has been approved by our Quality Assurance department,
the laboratory in which the method is performed must write a standard operating
procedure (SOP) describing the laboratory procedures involved. All SOPs must comply
with CompuChem's internal SOP writing guidelines, as well as the NELAC Standards
and are subject to our document control program. Our QA department approves all
SOPs before they are distributed within the laboratories.
CompuChem performs annual MDL determinations for all methods currently in use. Included
in CompuChem's MDL studies are verification of Practical Quantitation Limits (PQLs).
Method Validation Studies
Prior to analysis of any samples for approved methods not previously offered for
sale by the laboratory, a method validation study must first be performed. A chemist
familiar with the extraction/preparation procedures and the instrumental detection
systems reviews the as-written method. The chemist looks for safety hazards, applicability
of available instrument systems, new equipment requirements, any discrepancies in
the written method, and the QA/QC requirements. A plan of testing approach is discussed
with the laboratory director, technical directors, and executive management. Analyses
of laboratory spiked matrices are performed to determine overall method recoverability.
A draft SOP is written after the method validation study has been performed.
Documentation includes an MDL study, a precision and accuracy determination, and
a draft SOP. This and any other pertinent information is then forwarded to the QA
department for final approval. Any deviations from the published method must be
noted in the SOP. Once approval by QA and SOP document control is completed, product
codes can be developed and the new method can be offered to clients.
Data Quality Objectives
Data quality objectives (DQOs) are used in planning environmental data collection
activities. They establish the level of data that are needed to support decisions
regarding the site. They establish the level of uncertainty in results that a decision-maker
is willing to accept. They can be used to define QA/QC programs specific to a project
or data collection activity. DQOs have been established for programs under which
the laboratory provides analytical services. Internal project support staff work
closely with the client and regulatory agencies to ensure that DQOs will be met
by the analytical results provided. The project management teams at CompuChem convey
project- and client- specific requirements to the laboratory by using and distributing
a unique project profile sheet (PPS) and meeting on a regular basis.
When out-of-control events occur, they are documented and corrective action is implemented.
Corrective action is the process of identifying, recommending, approving, and implementing
measures to counter unacceptable procedures, deviations from laboratory standard
practices and procedures, or out of control quality control (QC) performance that
can affect data quality. To the extent possible, samples are reported only if all
QC measures are acceptable. If a QC measure is found to be out of control, and the
data are to be reported, all samples associated with the failed QC measure are reported
with the appropriate data qualifiers. How such events are documented depends on
the type of event and area where the excursion occurred. Most out-of-control events
identified during routine sample processing are restricted to single samples, batches,
or data reports. Some examples of these types of events include:
- incorrect client identifier on chain-of-custody (COC) documents
- improper or broken sample containers
- unpreserved or improperly preserved samples
- lab accident during sample processing
- accuracy failures for surrogate and/or spike standards
- precision failures between duplicates
- variations in internal standard responses
- contamination of method blank
- missed holding time
- errors or omissions in data reports
Corrective action may occur prior to, during and after initial analysis. Corrective
actions are performed prior to release of the data from the laboratory. The corrective
action is addressed in the SDG Narrative by the case reviewer and on the analytical
worksheets, signed by the analyst and reviewed by the supervisor. The types of excursions
that occur and the corrective action documentation that results during different
stages of sample processing are discussed in the following sections.
Corrective Action Types
CompuChem has two separate corrective action policies that are in effect and are
initiated, depending on the item requiring corrective action. As a result of external
and internal system audits or external and internal data audits, identified defects,
findings, and even observations will result in the generation of a Corrective Action
Report (CAR) by a representative of the QA department. The CAR identifies the deficiency
and is generally sent to the supervisor of the appropriate area. It also may specify
the action step needing to be taken. A turnaround time requirement is specified
and the CAR is returned to the QA department for approval. CAR documentation is
maintained in the QA department and is available to external auditors.
Sample-specific corrective actions are addressed in the laboratory Standard Operating
Procedure (SOP) collection. Sample-specific corrective actions include repeats due
to unacceptable surrogate recoveries, internal standards not meeting acceptance
criteria, dilution re-injection requirements, etc. These types of corrective actions
do not require CAR documentation. For certain occurrences, laboratory notices are
prepared and are included in the SDG Narrative section of the deliverable package,
as well as discussed in the narrative itself. Most of these notices are prepared
after discussions with a QA department representative. They do identify the event
and address the corrective action. The Case Reviewer is responsible for assessing
them and addressing all sample-specific corrective actions in the report narrative.
Case Reviewers are the most senior members of the technical staff and are given
the authority to approve laboratory notices as the laboratory managers' designee.
When project issues are brought to our attention, the appropriate Project Manager
is usually first contacted. They complete a Client Inquiry form and take it
to the personnel responsible for addressing the issue. Sometimes, a CAR will be
initiated based on the concern. The policies are further discussed below.
Sample Receipt Discrepancies
Any discrepancies noted during the sample receiving process are documented on the
COC form. Information about discrepancies is provided to the appropriate Project
Manager, who is responsible for contacting the client about the problem and documenting
the resolution in a phone log. If the client instructs the laboratory to proceed
with sample analysis, a Quality Assurance (QA) Notice explaining the problem is
included with the data package and the discrepancy is addressed in the SDG Narrative
by the Case Reviewer. This process is commonly used when samples are received at
higher than required temperatures or have been improperly preserved. If a sample
is broken during transport to the laboratory, the Project Manager notifies the client,
who, in turn, notifies the field crew to resample if possible. Notification of potentially
high concentration samples should be conveyed from the client and entered into the
LIMS laboratory instructions field.
Out-of-Control Events at the Bench
Out-of-control events noted and corrected at the bench by technicians or analysts
are recorded on sample preparation worksheets, sample analysis worksheets, instrument
runlogs, calibration or temperature logbooks, or instrument maintenance logbooks,
as applicable. This includes condition codes on analysis worksheets and in the LIMS.
Condition codes are used to describe the status of a sample analysis and whether
reanalysis is required. The codes can be indicative of trends. A QC failure normally
generates a request for re-extraction and reanalysis, but depends on the occurrence
or method. For instance, an MS/MSD does not have to be repeated for a surrogate
failure when the original unspiked field sample also demonstrates the same failure,
confirming sample matrix interference. Other QC failures may prompt the reanalysis
of samples and qualifying of results. The analyst makes the determination that corrective
action is needed. The type of corrective action needed has been specified in SOPs
through approval of the Vice President of QA and Technology. The case reviewer,
authorized by the Laboratory management for release of the data, further documents
these incidences in the SDG narrative.
Data Report Errors or Omissions
If errors or omissions in data reports are found during any of the review processes,
the organics data are corrected online in the ThruPut data management system. The
type of correction made and the person who made the correction are documented in
the audit trail within ThruPut. A QA notice or laboratory notice may be included
with any reported data that does not meet all quality control criteria or which
requires explanation. This notice, or the SDG narrative, describes any out-of-control
events and corrective actions taken to remedy them. The Case Reviewer, who authorizes
release of the data report, writes the SDG narrative.
Out-of-Control Events during QA, Management, or External Audits
During various internal or external audits, an out-of-control event might be observed
that can adversely affect laboratory quality on a more global basis. These events
might affect, for example, entire analytical systems; projects; data usability or
integrity; or sample integrity and security, or personnel safety. An unacceptable
result on a performance evaluation (PE) study or internal blind PE study can also
be an indication of a systematic problem. Other examples include:
- >temperature excursions on successive days in a sample storage refrigerator
- improperly calibrated analytical equipment
- poor spike recoveries on multiple extractions of a laboratory control sample
- contaminated glassware or sample/standard storage
- inaccurate/incomplete SOP or personnel not following SOP
- deviations in COC documentation or procedure
- obliterations, writeovers, or other improper data corrections
- expired standards on the "active" shelf of a refrigerator
- open or unlabeled waste containers
- inadequate hood velocity
These out-of-control events and the corrective action taken to resolve them are
documented in several ways, such as:
An interoffice memorandum is written to the responsible party describing the out-of-control
event and requiring a written response including corrective action by a specified
date.
After internal or external audits, a formal report is written to all involved laboratory
areas that describes any non-conformances or deficiencies found.
Written responses must detail corrective actions taken. For external audits, these
responses are included in the formal written response to the auditor.
A Corrective Action Report form is completed when an external or internal client
identifies a deficiency. This form documents what the out-of-control situation is,
who is responsible for correcting the problem, what action is to be taken, and the
target date for implementation. The form is used to enter information into a tracking
database.
The nonconformance is closed once QA or lab management has determined that implementation
is complete and that system control is restored. Reports are kept on file.
Corrective action will be initiated as a result of performance or system audits,
split samples, or data audits.
Acceptance limits for CLP methods are published in the Statement-of-Work (SOW).
Limits for non-CLP methods or limits that are not specified in the method are subject
to change based on updated intra-laboratory statistical performance data. Generally,
acceptance criteria are advisory unless the client requires specific corrective
action steps for failures.
Client-Identified Discrepancies
Clients who have a question or problem with a data report will call their Project
Manager (PM). The PM completes a Client Inquiry form and directs the issue to the
appropriate lab supervisor for resolution. Most often these issues are related to
poor copy quality, a missing page from the report, or a technical question. The
PM handles client inquiries and provides a copy of the resolved inquiry to QA. Depending
on the circumstances, QA may elect to issue a CAR based on the inquiry. The PM provides
a response and provides supplemental documentation within an agreed upon time frame.
Where a complaint, or any other circumstance, raises doubt concerning the laboratory's
compliance with our own policies or procedures, or with the quality of our tests,
the laboratory ensures that those areas of activity and responsibility involved
are promptly addressed and audited. Records of the complaint and subsequent actions
are maintained.