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Organizations who perform analysis and/or sampling activities for programs specified in Categories 2C, 3 or 4 of Chapter 17-160, F.A.C. are required to have an approved Comprehensive Quality Assurance Plan (CompQAP) on file with DER.
The Comprehensive Quality Assurance Plan may be submitted in one of three ways:
1. Prepare a document written according to the requirements specified in the "DER Manual for Preparing Quality Assurance Plans" (DER-QA-001/90);
2. Adopt and use all relevant Standard Operating Procedures (SOPs) discussed in Chapter 3 through 13 of this document by submitting a Statement of Intent with a list of equipment, capabilities and staff; or
3. Adopt selected SOPs and incorporate them into a document that is written in accordance with DER-QA-001/90.
If SOPs are adopted in a CompQAP, the Department requires and expects that all adopted protocols will be followed WITHOUT MODIFICATIONS, when collecting and/or analyzing samples related to DER rules and regulations.
The procedures in this document SHALL NOT be used as:
1. Substitution for Department-written Standard Operating Procedures that have been written for a specific program activity; or
2. Replacement or substitution of the Comprehensive Quality Assurance Plan and/or a Quality Assurance Project Plan (Category 2C, 3 and 4) requirement.
1. Chapter 2 of this document outlines the format, specifications and submission requirements for CompQAPs that adopt all or part of the Department's SOPs.
2. Chapters 3 through 13 discuss the specific standard operating procedures (SOPs) that may be incorporated by reference into a Comprehensive Quality Assurance Plan.
3. Appendix A of this document provides of list of terms AS THEY ARE DEFINED AND USED by the DER Quality Assurance Section and EPA.
4. Appendix B of this document provides of list of reference documents.
1.1.2 Mandatory and Recommended Requirements
The words "must", "shall", "may", and "should" indicate differences between mandatory and recommended requirements:
1. The words "must" and "shall" are used to indicate those topics and protocols that must be followed in order to be in compliance with the SOPs.
2. The words "may" and "should" indicate protocols or topics that the Department recommends following, but are not mandatory.
Some of the information in Chapters 3 through 13 of this document is included for informational and educational purposes. Such information is identified by double brackets ([[ ]]) which surround the text.
1.2 GENERAL SUBMITTAL REQUIREMENTS
1. All required Quality Assurance Plans must be submitted and approved or approved pending before sampling and analysis on the specified project can begin. Requirements from other DER sections (work plan, permit approval, consent order, etc.) may need to be satisfied before work can begin.
2. All consultants and laboratories are encouraged to submit plans well in advance of anticipated work. Most Quality Assurance Plans are returned for at least one revision before approval. If possible, plans should be submitted at least 60 days before the anticipated start of sampling and analysis activities.
1.2.2 Parties Responsible for Submitting Comprehensive QA Plans
1. The CompQAP must address the capabilities of the specified organization in a single document. CompQAPs for separate programs or purposes (i.e., Chemical, Biological, Hazardous Waste Sampling, "Tanks" work, etc.) are not accepted by DER.
2. If an organization or corporation has sampling and analysis capabilities in the same physical location, a single CompQAP must be submitted. Separate CompQAPs will not be accepted.
3. Organizations who: 1) have the same street or mailing address; 2) have identical key personnel; and 3) have identical equipment and capabilities shall not submit multiple CompQAPs for approval even if the name of the organization is different.
4. If required, all organizations shall perform sampling and/or analysis activities under the CompQAPs of their organization. Organizations shall not operate under the CompQAP of another organization.
5. If a corporation or company with multiple branch offices or laboratories wishes to submit Comprehensive QA Plans for approval, these guidelines must be followed:
a. Laboratory CompQAPs (includes full service laboratories with both field and laboratory capability)
1. University systems that require CompQAPs may submit a CompQAP for each Department or laboratory.
2. A separate CompQAP must be submitted for each laboratory located in different cities.
3. A single CompQAP for multiple (branch) laboratories of a corporation is acceptable if:
a. The branch laboratories operate under identical Standard Operating Procedures Manuals;
b. The branch laboratories are electronically linked with each other through a single Laboratory Information Management System which incorporates data from all branches and generates the Quality Assurance Targets for all laboratories;
c. All data from each laboratory is accessible through the laboratory information system to all other branches;
d. Employees from other branches are under direct supervision of the project manager in charge of the project, even if that manager is located in another branch office; and
e. The project manager is responsible for reviewing and approving final data reports even if the data is generated by another branch.
The CompQAP must include assertions that the above-stated requirements have been met (Section 1.0 of a CompQAP that has adopted all SOPs or Section 4.0 of a CompQAP that adopts some of the SOPs).
b. Field CompQAPs
1. A single Comprehensive QA Plan is acceptable for all branch offices of the company or corporation if each office has the same capabilities and if similar equipment and field procedures are used.
2. CompQAPs from individual branches shall be required f the capabilities, or standard operating procedures are not the same for all branch offices.
1.2.3 Amendments to Approved Comprehensive QA Plans
1. By rule, approval for a Comprehensive Quality Assurance Plan must be renewed once a year on the anniversary date of DER approval. If nothing has changed during the previous year, a letter must be sent stating that the laboratory or consulting firm wishes to renew approval.
a. Failure to submit amendments or a letter will mean that approval of the plan will expire on the anniversary date.
b. All QA Project Plans which reference an expired CompQAP will be returned unreviewed. If the approval of the CompQAP is renewed at a later date, the unreviewed plans may be resubmitted.
c. If approval of a QA Plan has expired, the approval may be renewed by submission of the required amendments or renewal letter described above. Such approval will be from the date that the amendments are approved, not from the anniversary date.
2. In order to renew approval, the revisions (or letter) must be received by the QA Section 30 days prior to the anniversary date, and must be approved on the first or second submission. Amendments at any other time will not be reviewed unless:
a. The company or laboratory changes name or organizational structure (i.e., buys or is bought by another organization).
b. The company or laboratory adds new capabilities (e.g., ability to sample hazardous waste) or new methods (e.g., pesticide analytical program is expanded) which will be used for work performed under the QA plan.
c. The company or laboratory acquires new instrumentation or equipment that will add new capabilities. New equipment or instrumentation that does not provide new capabilities (e.g., addition of another Atomic Absorption spectrophotometer for previously approved furnace work or replacement of an instrument) does not require an immediate amendment.
d. DER requests amendments to clarify, correct or update portions of the CompQAP.
3. When a section (or sections) is (are) amended, the revision date of the amended section(s) shall be updated to the current date.