Presentation on theme: "Lecture 8. Quality Assurance/Quality Control The Islamic University of Gaza- Environmental Engineering Department Environmental Measurements (EENV 4244)"— Presentation transcript:
Lecture 8. Quality Assurance/Quality Control The Islamic University of Gaza- Environmental Engineering Department Environmental Measurements (EENV 4244) Prepared by Husam Al-Najar
Introduction The policy document identifies environmental quality assurance and quality control (QA/QC) policies and procedures that have to be adopted and be followed by water and wastewater analysis laboratories to carry out sampling and compliance testing Laboratories must follow the policies and procedures set out document and they must ensure that they comply with all policies in this document in this Purpose of Policy Document It is aimed to guarantee that the highest standards are maintained within the laboratories that they are employing. The purpose of this document is therefore to clearly define the policies that the laboratories must adopt Requirements: All laboratories wishing to become certified must adopt all policies that are set out in this document and which cover the following areas: Laboratory Organization Personnel Quality Systems
Laboratory Organization: The laboratory should be a legal entity organized in a manner which permits the performance of all required functions in a satisfactory fashion Personnel – Qualifications, Experience and Responsibilities The laboratory is to have personnel with the necessary education, training and technical knowledge and experience for the tasks that are assigned to them Laboratory Director Analyst/instrument operator Technician Training The laboratories shall continually improve the technical capabilities and quality management. Laboratory staff shall, where necessary attend QA/QC training appropriate to their position and detailed training records shall be kept for each member of staff. The director shall be responsible for providing staff training and shall develop a training plan to satisfy the continued development of the laboratory
Quality Systems Each laboratory shall have a clearly defined policy (including a policy statement) in place which sets out clearly the laboratories commitment to meeting the requirements placed upon them for QA/QC procedures Quality Assurance Plan Each laboratory is to prepare a written description of its QA activities in a Quality Assurance Plan. This is to be a separate text from other documents that the laboratory needs to prepare. However, documentation for many of the listed QA plan items may be made by reference to the appropriate sections of the corresponding documents, such as the laboratory’s Standard Operating Procedures (SOPs), or other literature. The QA plan must be updated regularly and as appropriate. All staff must be familiar with the QA plan and it must be available for, and submitted to auditors as and when requested.
The QA plan is to contain the following 1- Laboratory organization and responsibility. 2- Process used to identify Data Quality Objectives. 3- Standard Operating Procedures (SOPs) with dates of last revision 4- Field sampling procedures 5- Laboratory sample handling procedures 6- Calibration procedures 7- Data reduction, validation, reporting and verification 8- Type of quality control checks and the frequency of their use 9- List schedules of internal and external system and data quality audits and inter laboratory comparisons 10- Preventative maintenance procedures and schedules 11- Corrective action contingencies 12- Record keeping procedures 13- Laboratory safety procedures 14- Environmental conditions 15- Housekeeping Procedures
Standard Operating Procedures (SOPs) Each laboratory is to name and list all methods used for analysis, sample collection, sample preservation and holding times selected from an authorative source. An authorative source is any method that is internationally recognized and must be clearly documented by the laboratory. All SOPs must be dated and recorded in a systematic manner (such as in laboratory manuals), that are easily available for all staff. The following list identifies the details which should be included in the laboratory’s SOP document: Selection of certified (Standard) Methods for Analysis - The method must be appropriate for the analyte and sample matrix; -The method is the analytical method that has been recommended by authoritative sources; -The most up to date version of the methods is recommended for use by the laboratory; Methods for Sample Collection Sample collection methods to be followed shall be those recommended In the standard methods Methods for Sample Preservation and Holding Times Laboratories are to follow preservation procedures and holding times specified in the standard methods
Defined Detection Limits for each Method Detection limits shall be identified by the laboratory staff according to the standard methods. Calibration This is to include the type and frequency, source and standards, data comparability and instrument tuning Defined precision and accuracy for each parameter Precision and accuracy is to be achieved using control charts, laboratory fortified blanks, and matrix duplicates. Other QC Checks This may include such checks as performance check samples, internal and surrogate standards or matrix spikes and replicates
Document Control The laboratories are to have strict procedures for records and data reporting for all activities. These are identified below Sampling Record Contents Analytical Records Storage of Records Archiving Chain (transfer) of custody Access to Records, updating and invalidation Obsolete Records Records of Corrective action and follow up actions
Equipment Laboratories must have instruments and equipment that are necessary for performing the methods that have been approved. These will be dependent on the tests which the specific laboratories are being commissioned to Lists of equipment and operation and use instructions are to be documented in a systematic manner. Where equipment is replaced or updated, data of decommissioned equipment should be archived Equipment Maintenance All equipment that is used for sampling and analysis must be listed and must be routinely calibrated, inspected and maintained to ensure their accuracy. This is to be carried out according to manufactures procedures and schedules. The laboratory is to ensure that records of routine equipment calibrations, maintenance activities and inspections are kept up to date and accurate. (These need to be done according to manufacturers specifications which must be reported/specified by the laboratory) Measurements – standards and calibration of equipment Standards and calibrations must follow those prescribed for use by the equipment manufacturers or in the standard method followed. These must be recorded in the laboratory’s Quality Assurance Plan. Calibration certificates are to be recorded. Complaints and Appeals Procedure The laboratory is required to have a mechanism in place to deal with technical questions, appeals, complaints and challenges. Records shall be maintained of all complaints and of the investigations and corrective actions taken by the laboratory.
Notification of Nonconformance The laboratories shall notify directly within 24 hours of approving test results that are in violation with any specified water quality standard with which it is expected to meet or which show a change to water quality trends that have been routinely recorded. All notification is to be done in writing. Purchasing Services and Supplies The laboratory shall have a policy and procedure for the selection and purchasing of services and supplies it uses that affect the quality of the environmental tests and/or calibrations Environmental Conditions Laboratories must have adequate heating, cooling and humidity control systems and all spaces must have sufficient lighting, ventilation (e.g. exhaust hoods, fume labs, etc where required) in addition to adequate and convenient electrical and water supplies. Safety Procedures, Equipment and Training Laboratories are to have a comprehensive safety plan/procedures document that is well known and followed by all employees. Safety training must be included in the initial induction of new staff members and ongoing refresher training sessions should be provided on an annual basis to all staff
Housekeeping Procedures Laboratories must have a good housekeeping programme in place and must keep cleaning materials stored accurately and easily accessible. Appropriate cleaning materials must be procured at all times Auditing Internal Auditing All laboratories shall implement an internal audit procedure to cover all aspects of the QA/QC procedures set out in its document. Interlab Proficiency Testing Laboratories will be required to participate in any interlab proficiency evaluation scheme, at least annually