MB LABS --- Company

QA/QC

Accreditation
and Certification

President's Message

Employment Opportunity

Company>QA/QC

QUALITY ASSURANCE & QUALITY CONTROL

Introduction

The Quality Assurance and Control program is an essential function of MB Laboratories Ltd. The purpose of the program is to ensure the reliability and validity of all analytical results. Our Quality Assurance (QA) program specifies policies and procedures that assure the integrity of analytical data and demonstrates our commitment to quality. Our policies are consistent with regulatory guidelines and meet or exceed industry standards.

Information Management

LIMS5, the Laboratory Information Management System developed by MB Laboratories Ltd, handles all of the sample log-in, scheduling, QC data, test results, routine calculations, reporting and sample storage assignments for the laboratory.

The laboratory utilizes a number of specialized, proprietary programs for many of its professional services. These include SWAMI , a professional taxonomy program for microbial identification, and Buglister , a comprehensive database and reporting tool for fungi, bacteria, yeast and algae/protozoa.

Standard Operating Procedures (SOP's) are used to define and describe each routine analysis performed by our laboratory. SOP's include information on the following topics:

Sample collection, preservation and holding time
Sample receipt, custody and document control
Analytical method
Instrument calibration and maintenance
Quality control
Safety and Hygiene
Confidentiality

Analytical methods are derived from standardized protocols and guidelines provided by the EPA, APHA, NIOSH and ASTM. Any analytical method that deviates from these guidelines is thoroughly documented by laboratory staff.

Routine quality control measures includes:

• replicates, spikes, blanks, standards, & primary certified reference material
• unusual results or values that are at or over regulatory limits are routinely verified by an alternate analytical method.

Chain of Custody. Appropriate forms, collection containers and instructions are available from MB Laboratories Ltd.

Facilities & Personnel

Physical	- 4,000 square feet, well ventilated and air-condition to provide a stable ambient temperature 20-22C - walls are finished and have washable surfaces – floor is finished with vinyl commercial grade tile. - uniform glare – free lighting is provided from full – spectrum bulbs and specialized areas are provided with additional halogen lamps - each analyst has in excess of 2 meters of bench space – all work benches are laminate - all sink areas are continuous stainless steel - separate physical areas are provided for wash-up, preparation and sterilization, sample receiving, holding, and analysis.
Maintenance	- the laboratory floors are professionally cleaned on a contract basis - all benches and sink areas are washed and disinfected daily
Air Quality:	- Air filters on the air-conditioning unit are inspected and changed monthly - airborne microbial contamination tested monthly or as required - extensive airborne chemical contaminants are tested quarterly - laminar airflow hoods are tested daily for airborne contamination
Laboratory Classification	- The laboratory is maintained and classed as a level 2 containment, level 3 handling facility. All criteria set out by Health Canada, CFIA and WCB are maintained and enforced.
Personnel:	- all permanent laboratory staff are graduates of technical training in laboratory procedures (diplomas) and/or have post-secondary degrees (University BSc). - many of the professional staff hold advanced degrees or training (Masters, Doctoral or Technical Specification Ratings in Registered Technologies) - in-house training programs take 1-4 years. - temp (eg. summer students) positions are closely supervised and are not allowed to proceed with any task alone. - handling of materials and samples containing high titres of microbes is restricted to trained personnel who have proven aseptic techniques (including chemists). All personnel must undergo training as outlined in our manuals.

Reference Standards:

Microbiology: The company maintains an extensive culture collection. The collection includes certified reference strains from recognized sources such as American Type Culture Collection, US Food and Drug Administration and US Environmental Protection Agency; industrial strains and research isolates. These micro-organisms are used both for routine QC functions and for on-going research projects.
Chemistry: Certified reference material and standards are purchased from a variety of reliable suppliers.

Final Results: Copies of the certificate of analysis are kept on file both as hard copy and electronic files In case of emergency, results will be phoned out to a contact person designated by the client. All final results are forwarded by mail. Bench-sheets are kept on file a minimum of 3 years. QA/QC bench-sheets, monitoring logs, standards (primary & secondary), blanks, controls, and duplicates are kept on file in the laboratory.

Special Report Formats
The laboratory routinely formats and transmits electronic copies of data to Watertrax, EMS and spreadsheet (Excel) to and for clients. Formats that are unique to a client may also be accommodated.