Quality Digest      
  HomeSearchSubscribeGuestbookAdvertise August 9, 2022
This Month
Home
Articles
Columnists
Departments
Software
Need Help?
Resources
ISO 9000 Database
Web Links
Back Issues
Contact Us

by Kim Rosenstein

Given the evolution of quality systems, the science of measurement and the constant drive for increased productivity, selecting calibration software can be challenging to say the least. Companies whose livelihoods depend upon it must choose an excellent system. Variables in the process are numerous and don't necessarily contribute to straightforward decision making. The criteria for evaluating and selecting calibration software fall into four primary categories: quality system compliance, laboratory requirements, system requirements and budget. Each category can significantly affect the others, so any software selection must be weighed and balanced for optimum system performance. Let's take a closer look at each category.

Quality system compliance

The principal driving force behind calibration software is compliance to quality standards. During the past 20 years, the metrology industry has had to comply with myriad standards, beginning with MIL-STD-45662A and continuing with ANSI/NCSL Z-540, 10 CFR 50 Appendix B, ISO 9001, ISO/IEC Guide 25 and ISO/IEC 17025, among others. As global economics have evolved, so have international standards.

Calibration software should be designed to help maintain the highest quality levels--however they're defined. The system must consistently meet calibration, technical and quality requirements while also providing adequate controls over laboratory processes. Calibration software must properly address the following key aspects:

Protecting confidential information

Controlling calibration documents

Maintaining approved supplier lists

Documenting complaints and corrective and preventive action

Controlling and securing data records

Validating methods for calibration or testing

Documenting estimated measurement uncertainty

Controlling and maintaining measurement and test equipment

Documenting measurement traceability

Ensuring the quality of test and calibration results

Creating and maintaining test reports and calibration certificates

Providing laboratory and equipment status reports

Ensuring that quality requirements are met is the critical first step in selecting calibration software. The software must be capable of thoroughly recording the calibration process and data with absolute integrity and assurance. If it fails to meet specified quality requirements, the laboratory itself risks failing critical quality, certification or accreditation audits.

Laboratory requirements

Although calibration lab requirements vary based upon an organization's size and type, two types of calibration laboratories predominate: in-house and commercial. In-house labs typically support internal calibration needs. Commercial or third-party labs offer their services to a broad spectrum of industries. Both share the same quality requirements and productivity needs.

Today's calibration laboratories require dedicated, comprehensive calibration software systems to effectively manage their processes. In the quest for a comprehensive calibration system, it's important to identify the key criteria that your laboratory requires. Every quality system has certain unique requirements it must satisfy, and identifying these requirements during the initial selection process will save both time and effort.

Although most calibration systems offer the same basic features and functions, you should thoroughly evaluate the following areas to determine their applicability for your needs:

System design and architecture that meet overall quality and laboratory requirements

Security system designed to preserve the integrity of confidential electronic records

Uncomplicated user interface to allow quick and easy access to desired information

Complete set of tools to manage the calibration process, from initial order to completion

Data organization designed for minimal data entry and maximum throughput

Production of complete and correct calibration documents

Documentation of measurement uncertainty results

Production of laboratory management and productivity reports

Ability to electronically transmit reports and data via e-mail or other methods

Flexibility for customizing field names to complement existing laboratory terminology

Advanced filters to quickly find records that match desired criteria

Documented system validation and verification protocol

In addition, the calibration software must help your company remain viable and profitable in the marketplace by meeting customer expectations and increasing productivity with minimum personnel. Careful consideration should be given to satisfying the needs of clients, management, administration, metrologists and quality personnel.

Measuring and test equipment users need to know that their equipment has been properly calibrated, as evidenced by calibration documents. Therefore, the calibration software should produce complete and correct calibration certificates, reports and labels. Errors in calibration documents cause unnecessary delays and corrective action. One method of reducing errors is implementing predefined "pick lists." Systems that incorporate these user-defined lists can prevent operator errors while increasing data-entry efficiency. An effective calibration system will help minimize errors and, in turn, raise productivity.

Turnaround time is affected by many variables, some of which are beyond the laboratory's control. However, an effective calibration software system will track and monitor the status of each item in process to minimize backlog and reduce turnaround time. Management tools designed to track productivity are invaluable resources for monitoring lab and personnel performance. The lab's work tempo must be under constant surveillance to ensure quick turnaround time and high productivity and to prevent potential problems from slipping through the cracks.

Security is of utmost concern to management and quality personnel. Electronic records are an ever-increasing part of our society and an integral part of the calibration process. The system must incorporate a comprehensive security scheme to safeguard data and limit system access to authorized users only. Various levels of permission must be granted for individual users within the system. Login rules further define user access in terms of number of login attempts and automatic user inactivity logouts. Automatic, computer-generated, time-stamped audit trails should be used to independently record the date and time of operator actions that create, modify or delete records within the system. Calibration records should be signed and time- and date-stamped by authorized individuals. Authority checks further ensure that only authorized individuals can log into the closed system.

Security is an even greater concern for facilities that must comply with the FDA Title 21 Code of Federal Regulations concerning electronic records. According to this regulation, electronic signatures are an integral requirement for securing electronic records and limiting system access. Key elements of a closed calibration system that complies with 21 CFR Part 11 include:

Authenticity, integrity and confidentiality of electronic records

System validation to ensure accuracy and reliability

Ability to distinguish invalid or altered records

Ability to generate accurate and complete copies of records

Protection of records for accurate retrieval throughout the retention period

Limited system access to authorized users only

Computer-generated, time-stamped audit trails to record operator transactions

Authority checks to ensure use by authorized personnel

Maintenance of system development and modification documents

Calibration software systems that properly comply with 21 CFR Part 11 yield significant advantages. The records these systems maintain are considered trustworthy, reliable and generally equivalent to their respective paper records. Furthermore, electronic records that meet the requirements of 21 CFR Part 11 may be used in lieu of paper records, unless they're required or preferred by the recipient.

Calibration procedures and calibration data collection are important aspects of any calibration software system, and laboratory productivity and profitability are directly related to it. Huge amounts of data are gathered and processed for every calibration. Data from the client, asset, work order, calibration, standards, labor and parts must all be complete and correct.

Minimizing data entry is one way to reduce or eliminate transcription errors while increasing productivity and customer satisfaction. Automatic pull-down menus speed data entry, reduce errors and eliminate erroneous entries. Additional automatic data entry for system- or client-default information further enhances and increases each transaction's speed. Finally, an efficient software system should incorporate a comprehensive method of generating calibration procedures for collecting "as found" and "as left" calibration data. Effective calibration software should be intuitive, streamlining and automating as many processes as possible.

System requirements

Laboratory size, number of locations, users and assets will determine the type and configuration of the calibration management system. Dedicated calibration management systems typically address three types of users: the small user with a single workstation or small network, the medium-to-large calibration laboratory whose requirements can extend to multiple facilities, and labs that require the flexibility of in-lab and off-site mobility. The primary differences among these systems are the system architecture, database engine, development language, and available features and functions of the software.

For small users, common database engines are Microsoft Access, dBase, Paradox and FoxPro. These offer a low-cost solution for a single workstation and can be locally networked with a limited number of users. However, performance issues may arise when the number of records exceeds 10,000. These systems are typically adequate for laboratories on a limited budget.

Medium to large calibration laboratories are best served through an SQL database engine. There are several to choose from, but the most popular is Microsoft SQL Server 2000, which offers a highly scaleable enterprise database solution. It can be used in a client/server or n-tier application and is the preferred database engine for most calibration software systems. An SQL database system also provides the backbone for future Web interfaces.

Other SQL database engines include Oracle, DB2 and Sybase. Check with the calibration software provider to determine which database engine is recommended and what software licenses you'll need.

Other considerations include the requirement for off-site calibration work. In this case, your calibration software must have the capability to be used both in the laboratory and remotely, either on a notebook PC or PDA device. The system should replicate the data, a process that duplicates and transfers required data between the mobile device and server.

If you're upgrading from another system, you'll need to address how to migrate your current data into the new system.

Fortunately, data migration into most SQL databases is straight-forward. However, difficulties can arise in extracting the data from older systems or filtering out bad data.

Budget

When preparing a budget for purchasing calibration software, consider your quality and lab requirements, your type of laboratory, the number of locations, users and the type of calibration work you perform. You'll also have to budget for installing the system, training personnel, receiving software support and migrating legacy data, if applicable.

Quality calibration software that's designed to meet ISO/IEC 17025 and 21 CFR Part 11 will vary in price and performance. This type of calibration software has been designed and tested to the most rigorous requirements in the metrology industry. Your job is to evaluate how well the system actually meets the quality requirements and your specific laboratory needs. In most cases you'll find the software is worth every penny and will most likely save you money.

Once you've narrowed your search and determined the total cost of the calibration software system, you can perform a cost-benefit analysis to determine your actual time savings.

A complete solution

The primary goal when evaluating and selecting calibration software is satisfying quality requirements. A system that can't comply with regulatory requirements isn't a bargain at any price. Next, evaluate the system to determine not only what it does but also how it does it. You'll find that many calibration software systems perform similar tasks, although their methods can differ substantially. The program's flow, data formatting and population significantly impact how well your team will function and perform with the new system. You shouldn't have to change your operating procedures to fit the software, and the software shouldn't force you to do more work than required. Look for a complete solution to your needs. A system that's powerful and robust, yet still provides flexibility, will increase your company's productivity and improve quality.

About the author

Kim Rosenstein is currently a technical trainer and road warrior for Cybermetrics Corp. in Scottsdale, Arizona. She has spent 70 percent of her time this year conducting training classes at client locations. Ditloff has degrees in English and information technology. She has worked as a teacher, technical writer, programmer and systems analyst. Letters to the editor regarding this article can be sent to letters@qualitydigest.com