A quality manual, linked directly to the policies and procedures, is the heart of the online quality system. Corrective Actions, Preventive Actions, Complaints, Training, Job Descriptions, and more, are readily available online as well. Record keeping only requires a mouse-click or two and the Database to track all of the equipment used for testing or calibration is also conveniently online.
A complete list of features:
- Equipment Database
- Lab Calendar
- Complaint form
- Corrective/Preventive Action forms
- Job Descriptions
- Management Reviews
- Policies & Procedures with links to mandating clauses
- Calibration Suppliers linked to Equipment Database
- Training records linked to employee records
- Consumables/Materials records
- Document database for standards, test methods, etc. linked to authorized signatories
- Incoming inspection of purchased item
- Method validation
- Non-conforming work
- Proficiency Test
- Supplier Evaluation
- Others can be added
Any instrument, accessory, or transducer that can affect the validity of results must have records maintained in the quality system. Each asset must have a unique identifier (often a capital asset tag), manufacturer, model number, serial number, last calibration date, calibration interval, user manual, location and any other pertinent information. This record should also contain the calibration certificate and any necessary correction factors. The online availability of this information lowers the risk of using equipment that has gone past its calibration due date and makes adding the appropriate information to test or calibration reports a simple matter of cut & paste.
This feature automatically populates itself with links to equipment going out of calibration, management reviews, training, events, and more; all of which appear on the dates you enter for these items. As you create management reviews, training records, audits, and events, there is no further effort for you to show them on the calendar. A timeline of the activities in the lab is clearly visible and provides one more simple way of monitoring your quality system.
Complaints & Corrective/Preventive Actions
Many laboratories (and people) seem to consider a complaint as a negative thing. Yes, this is sometimes true, but it is also an opportunity to fix a problem. If the customer did not complain, then they simply went someplace else and you lost the opportunity. The customer talking to you is always good, and having an effective procedure on how to handle complaints can go a long way towards a successful laboratory. But, once problems are discovered, whether through complaints, audits, or other means; then corrective actions need to be implemented and followed up to make sure that the problem really gets fixed. Sometimes, along the way, other problems, issues, or concerns pop up and need to be addressed before something happens. Preventive actions need to be put in place to make sure they get done, similar to your own To-Do list.
Job descriptions have been created for all the roles in the laboratory. ISO/IEC 17025 frequently says "shall ensure that..." and these responsibilities have been added to the job description with a link from the quality manual, procedure, or policy mandating them. By doing it this way, the quality manual will say something like "The Technical Manager is responsible for ensuring the calibration of equipment" as opposed to having the manual say "the laboratory shall ensure that equipment is calibrated" and the job description of the Technical Manager will list ensuring the calibration of equipment as one of his/her responsibilities. By creating roles in the laboratory through job descriptions and assigning people to those roles, the responsibilities are strongly linked to the quality system, which "ensures" that they are understood; which, for most people, makes it easier to implement because they understand why.
One of the major reasons for performing management reviews within a quality system is to completely review the quality system at each review (typically once a year). In preparation of the review, a record can be created and events can be recorded with appropriate links to supporting evidence, such as internal audit results, completion of corrective or preventive actions, complaints, etc. Considerations for the change in volume or type of work being performed in the laboratory are also important and can be listed in the record for a management review.
By working on the management review record all year, the linked evidence to be reviewed is already there so that management can simply click to review all the important information before making suggestions for improvements. The more seriously one takes a management review, the greater the benefit is to the laboratory. Handling these records using an online system allows everyone to see it and contribute, adding even more value. With everyone's busy schedules, efficient reviews of the good, bad, and ugly taking place in the laboratory, is the quickest way to improve things and take care of customers better.
For any vendor that is used for purchasing or renting equipment, consumables, reagents, etc., it is important to maintain records of these suppliers and any accreditations they need to ensure that the requirements of ISO/IEC 17025 are met. The supplier evaluation form tracks the relevant information for each supplier and in the case of an external laboratory being used for the calibration of equipment, each asset has a field that allows only the approved suppliers to be entered with a direct link to their record. This is quite a convenient method of making sure that only an approved supplier is used.
Training records couldn't be easier. Enter the training information directly into the record, add the list of attendees, and the record is complete. As an added bonus, the record is automatically attached to the staff members page so that no filing is required. If there is a separate file (signed sheet, powerpoint presentation, etc.) then upload it to the training record and it will be available for everyone to use in the future.
Document control will also become a breeze. Add a document to the quality system by adding new content of type "Document", enter the title, description, issue date and/or version, and then upload the document. It is now safely under document control. Clause 5.2.5 requires the laboratory to identify which staff can perform testing (calibrations) to which standards. After each document is added, members of the staff can be authorized to test (calibrate) to the standard/method and who is authorized for every document will appear on the document page. Additionally, each staff member's page will also include a list of documents they are approved for.
Maintaining the necessary records in a quality system can be a daunting task. The OpenTestLab quality system provides a simple method for creating, organizing, storing and retrieving records. Just Add content of type Record and attach any necessary evidence (such as checklist sheets or scanned-in hand-written documents), write a brief description of what the record is and then save. The list of records are available through the left-hand menu and can be organized and viewed by the type of record. Incoming inspection of purchased items, method validation, and non-conforming work records can be entered as the record type and can be searched for using the search box on the website. If other types of records need to be added to the quality system, update the Record Type Taxonomy with another type and it will be made available for selection when adding the next record.