The incomplete application of the Quality Assurance system inside wastewater laboratories will lead to obtaining inaccurate and unreliable laboratories results, and these inaccurate results will lead to incorrect decisions that will affect the proficiency of wastewater treatment plants and affect the treatment operations parameters of the plant, therefore obtain treated water which not compatible to environmental laws and regulations.

So, applying a Quality Assurance system inside the laboratory is very important for obtaining accurate and reliable analytical results.

Implementation of the Quality Assurance system inside the laboratory is considered to be one of the major standards that all wastewater laboratories should be done.

The application of a Quality assurance system in laboratories improves the quality of test results and elevates the confidence level from the customer side.

The laboratory Quality Management System will consist of a Quality assurance manual, written procedures, work instructions, and records.

The manual should include a quality policy that defines a statistical level of confidence used to express the precision and accuracy of data.

Quality systems, which include quality assurance policies and all quality control processes, must be in place to document and ensure the quality of analytical data produced by the laboratory and demonstrate the laboratory’s competence.

What is quality assurance?

Quality Assurance is the definitive program for laboratory operation that specifies the measures required to produce defensible data of known precision and accuracy.

This program will be defined in a documented laboratory quality system.

Also, Quality Assurance can be defined as it is a part of quality management focused on providing confidence that quality requirements will be fulfilled.

Quality Assurance objectives

It is the responsibility of the laboratory’s management to identify and state, in writing, what the quality goals of the laboratory are to be.

The primary objective of a laboratory’s quality assurance system is to improve and maintain at a high level the precision and accuracy of the laboratory’s “product.” the “report issued as the consequence of analytical, measuring, or testing activity undertaken on a sample or samples obtained from some source” can be characterized as the laboratory’s product.

Management, administrative, statistical, investigative, preventive and corrective techniques are among those which may be used to maximize the quality of the reported data.

Secondary objectives which may be established to reach primary goals might be:

1-To establish the level of the laboratory’s routine performance.

2-To make any changes in the routine methodology found necessary to make it supportive of the management policy regarding the reduction of costs associated with corrective action and evaluation.

3-To set objectives associated with achieving management’s mandate to assure continuous improvement of quality performance.

4-To establish program goals for the laboratory’s quality and technology training efforts.

laboratory quality management systems are based mainly on quality control activities and quality assurance and consist of a Quality assurance manual, written procedures, work instructions and records.

The quality system of the laboratory includes a quality policy of the organization that guides the organization on the pathway to continuous improvement of its quality performance.

Stages of Establishment of Quality Assurance system inside wastewater laboratories

The quality assurance system of wastewater laboratories is based according to requirements of Standard Methods for the Examination of Water and Wastewater 20th Edition.

Standard Methods for the Evaluation of Water and Wastewater has been considered “the finest current practice of American and European water and wastewater analysts” since it was first published in 1905.

The 20th Edition of “Standard Methods for the Examination of Water and Wastewater is approved by the USA Protection Agency (EPA) Serving as a comprehensive guide for water and wastewater quality testing of a wide variety of contaminants in water and wastewater.

This comprehensive reference covers the following:

1- Each element of wastewater and water analysis methods.

2- All Quality Control measures and activities inside water and wastewater

3- All Quality Assurance procedures applied in water and wastewater laboratories to assure quality and accuracy of analysis

Studying the Laboratory’s Current Situation

Laboratory made an analytical study for all data and information specified to the laboratory’s current situation to know the exact status of the laboratory and evaluation the possibilities and available means for applying a quality assurance system laboratory.

Laboratory made a comparison between the requirements of Standard Methods for the Examination of Water and Wastewater and the actual practices done in the laboratory which are already applied in the current situation.

Gap analysis is done between standard requirements and available possibilities to determine the additional work that should be done to start applying the QA system as well as the efforts required to maintain laboratory efficiency.

Gap analysis results state that the laboratory needs more efforts to improve quality:

1- Lab staffs need more training in Quality control of analytical results.

2- Lab did not have standard procedures for sampling, calibration, and equipment maintenance.

3- Lab sampling staffs need training for proper collection and handling of the sample.

Enlightenment and Training of lab staff

All laboratory staff is subjected to training courses and practices which concentrate on Enlighten and informing them of the importance, goals, objectives and benefits of applying a quality assurance system inside the laboratory.

The following Training courses had been done internally for lab staff:

1- Gable wastewater treatment principles and techniques.

2- Sampling quality control.

3- Quality control for wastewater

4- Quality assurance for wastewater

All training courses and practices are designed well to ensure that all laboratory staff is aware of all necessary knowledge and information related to a quality system that affects their duties and tasks.

After training the courses and practices are reviewed and evaluated to determine the degree of awareness and benefits.

Writing all procedures, work instructions and documents

Procedures, documents, and instructions for sampling, analytical methods, instrument calibration, equipment maintenance, chemicals handling, storage, data reduction, validation and reporting, quality control, and corrective, and preventive actions had been written for preparing a quality manual.

Writing Quality Assurance Manual

Wither the assistance of consultants Quality manual is determined and written which includes all definitions and concepts of quality assurance and also includes the quality policies of the laboratory.

The quality manual refers to all procedures, instructions, actions, and policies that the laboratory follows to fulfill the managerial and technical requirements of the standard method.

Steps of Preparation for Write Quality Assurance Manual.

Preparation and writing Quality Assurance Manual of Gable laboratory-processed the following steps inside the laboratory:

1-All technical and administrative aspects inside the laboratory are organized and arranged.

2-The importance, goals, objectives, and benefits of applying quality assurance are determined and identified for all laboratory

3-Establishing Objectives and Priorities

4-Collection and Review of Existing Procedures.

5-Preparation of a Flowchart.

6-Identification of Program Requirements.

7-Identification of Shortfalls and the Assignment of Priorities.

8-Writing the Manual.

9-Reviewing and making necessary changes.

In the laboratory quality assurance manual all managerial responsibility, authority, quality goals, objectives and commitment to quality are specified and documented clearly.

The manual is written clearly to ensure that all laboratory personnel understands their roles and responsibilities.

Procedures are instituted to permit tracing a sample and its derivatives through all steps from collection through analysis to reporting final results to the laboratory’s client and disposal of the sample.

Adequate and complete documentation is performed to assure data defensibility and meet laboratory qualification requirements and ensure full traceability for all tests and samples.

Preventive maintenance procedures are used and documented for instrumentation and equipment to reduce instrument malfunction, maintain more consistent calibration, be cost-effective and reduce downtime.

Measurement traceability is included in standard reference materials in the Quality Assurance manual or Standard Operation Procedure to establish the integrity of the laboratory calibration and measurement program.

Logbooks are maintained for each test or procedure performed with complete documentation on preparation and analysis for each sample, including sample identification, associated standard and QC samples, method reference, date/time of preparation/analysis, analyst, weights and volumes used, results obtained and any problems encountered.

Logbooks are kept that document maintenance and calibration for each instrument or piece of equipment.

The data obtained from an analytical instrument are subjected to data reduction processes described in the applicable SOP before the final result can be obtained.

Calculations and any correction factors, as well as the steps to be followed in the generation of the sample result, are specified in the quality assurance manual or SOP.

Analytical results are reported in standard units of mass, volume, or concentration as specified in the method of analysis or SOP.

Application of System requirements inside the laboratory

Applications of Quality assurance System requirement according to the quality plan is done by making and activating all procedures and work instructions that cover all laboratory processes and activities.

Laboratory processes and activities include all laboratory files such as Standard Operation Procedures SOPs file, Instruments and Equipment file, Personal files, and Documents and Records files.

Review (Auditing) of laboratory Quality System

Auditing is processed to determine whether the quality activities and their results comply with the established documentation; to confirm whether these activities are appropriate for achieving the objectives proposed and whether they have been implemented effectively.

Review System Efficiency has been done by detecting the unconformity points for system requirements.

Internal auditing is performed by the Quality Assurance department.

Internal auditing has been achieved through all laboratory regulations and standard quality techniques and done for self-evaluation and improvement.

Corrective and Preventive Actions.

Corrective and Preventive Actions are executed to ensure achieving the goals of applying a quality assurance system followed by monitoring and controlling the execution of these actions.

References

[1] APHA, AWWA, and WEF, 2005. Standard Methods for the Examination of Water and Wastewater, Twentieth Edition, Washington, DC,2003.

[2] AOAC International (2006), Terms and Definitions. Available: http://www.aoac.org/terms.htm, accessed 23 September 2006.

[3] Thomas A. Ratliff, The Laboratory Quality Assurance system, John Wiley & Sons, Inc. 2003