Establishing a calibration management program

Denise M. Evans and Jim Erickson

FDA's strict calibration requirements emphasize the importance of establishing a comprehensive calibration management program. Calibration functions generally fall under the production and manufacturing or quality assurance and quality control departments. For start-up biotech companies and companies with new calibration employees, developing and implementing this complex plan can seem daunting.

Before implementing a calibration management program, you must first identify its benefits. Predominant is the ability to ensure product consistency and quality. A thorough program minimizes the possibility of errors, from missed calibrations to out-of-calibration instruments. A calibration management program ensures measurement consistency, procedural standardization, and correct use of standards.

Efficient systematic data tracking is another advantage of a calibration management program. When employees are trained to follow the policies and procedures outlined in such a program, the company saves money by minimizing human error and increasing productivity. A calibration management program can also act as a structured resource for new calibration employees, enabling faster assimilation of procedures. Implementing a careful, well-developed program will help the departments listed above enjoy successful audits.

Calibration Program Components

Increasing and ensuring the level of compliance for CGMPs is a challenge best faced by establishing the basic minimum components of a calibration management program. They include developing and implementing department-level calibration policies, instrument calibration procedures, documentation, and audit criteria.

Department-Level Calibration Policies

Calibration policies are an interpretation of CGMP regulations by the department responsible for calibrations. The first calibration policy is essentially an all-encompassing operational policy describing the program's general operation. The "Calibration Policy" box details basic policy format. Additionally, a calibration management program should include these department-level calibration policies:

calibration environmental requirements;

change control;

complaint documentation;

good documentation practices;

handling potentially contaminated instruments;

instrument identification and labeling;

personnel qualification and documentation;

personnel training documentation;

storage, handling, and transportation of calibration items; and

subcontractor certification.

Implementing a numbering system for policies and calibration procedures organizes and categorizes them for tracking purposes. Following the American National Standards Institute (ANSI)/National Conference of Standards Laboratories (NCSL) Z540-1-1994 Standard Index, you would assign an alphanumeric code using a policy prefix (AOI), followed by a category (Quality Manual). For more information about ANSI call (212) 642-4900, or visit the Web site at http://www.ansi.org. For information about NCSL call (303) 440-3339, or visit http://www.ncsl-hq.org. Instrument Calibration Procedures

Instrument calibration procedures make up the second critical component of a calibration management program. Especially when used with a database program, such procedures aid technicians by indicating comparisons with a standard, tolerance limits, and as-left values at the beginning of new calibration intervals. When implementing instrument calibration procedures, be brief, describing only what is necessary. Procedures should be written with the assumption that the person performing the task is sufficiently trained or under appropriate supervision.

Follow one of three basic formats when writing procedures: Specific to a measurement, device, or sensor type (in this case, the procedure is determined by measurement variables or individual types of instruments within an overall category);

Specific to instrument model numbers (in this case groups of instruments of the same type each have an overall procedure); Specific to instrument serial numbers (each instrument has its own procedure).

Best practice dictates that as many instruments as possible be covered with the fewest number of procedures. Written procedures should include sections on assumptions, stating exceptions and precautions; equipment needed, including specific standards; and calibration -- specifically, the performance documentation record, where as-found data are recorded. In that calibration section, the procedure can specify data points. If an adjustment is unnecessary, write "same" in the "as-left" section. If a correction is necessary, record final values in that section. Include also a section on completion that includes the performance documentation record and calibration certificate complete with data, signature, date, tolerance coding, and so on in black, permanent ink. When the above sections are completed, apply calibration labels to the instrument(s), and close out the work order. Documentation

The third critical component in establishing a calibration management program is documentation. Documentation includes establishing master records for instruments; creating history records for all activities relating to each instrument; and producing reports, forms, calibration certificates, work orders, and calibration and maintenance schedules.

Implementing a tracking and scheduling system for calibration and preventive maintenance assists in completing documentation. The system can also contain references to specific instrument calibration procedures. For fewer than 100 instruments, an index card or some other kind of manual file system may be adequate. However, to prepare for anticipated growth, or if more than 100 instruments are already being tracked, a reliable calibration database package provides speed, accuracy, and efficiency. Database packages also facilitate report and calibration certificate generation, and some include calibration labeling capabilities.

Equipment inventory. Begin by creating an equipment inventory of master records. Create a separate master record for each instrument. Enter the system identification numbers, unique component numbers, and basic information about each instrument, such as serial number, location, manufacturer, and model. Then implement and record a calibration and maintenance schedule for each instrument. Database systems enable automatic scheduling of those events and establish traceability. Using a database also facilitates verification of calibration intervals and tolerances.

Event histories. In addition to tracking an instrument inventory, a database enables tracking of event histories. Calibrations, maintenance, and other events can easily be recorded. Time and money allocated to maintenance can be tracked, as well as personnel responsible for calibrations and approvals. In addition, maintaining easily accessible audit trails with a database is an excellent method of preparing for and demonstrating compliance during an audit. If system security is established using passwords and user rights, the database method also provides a secure environment for critical data. As with any CGMP compliance application, the software should be validated.

Audits

A fourth critical component in completing a calibration management program is developing or adopting auditing criteria. Periodic audits ensure that a calibration program is effective and complies with appropriate standards and procedures. Regularly scheduled internal audits are not only an FDA requirement; they provide an excellent means of identifying opportunities for improvement. They are a useful tool for training new employees and supervisors or for jumpstarting a new company's calibration department. As an FDA requirement, internal audits and corrective actions should be well documented.

Trial audit. Internal audits also provide a trial run for formal FDA audits. A checklist of areas to review provides a thorough, consistent method for conducting audits. Be prepared to tell an auditor what you do, to demonstrate what you do, and to prove it. Anticipate what an auditor will need, and ensure that your calibration management system, as well as your audit procedures, will help you do it quickly and efficiently. Ask yourself the following questions about your current calibration program: Is documentation thorough, complete, and current? Can the data or audit trail be quickly and easily accessed during an audit? Conducting internal audits as part of your overall calibration management program will go far in preparing you for a formal independent audit demonstrating CGMP compliance.

Preparing a comprehensive calibration management program that includes calibration policies; instrument calibration procedures; documentation, including an efficient method for tracking and scheduling calibrations and related events; and audit criteria will help to ensure compliance and quality for your department or startup company.

[Reference]

References

(1) R.E. Bertermann and L. David Duff, The Metrology Primer (Blue Mountain Quality Resources, Inc., State College, PA, 1997).

(2) ANSI/NCSL Z540-1-1994 Standard Index.

(3) CM. Rice, Calibration Auditor-An Audit Guide to Good Calibration Practices (Blue Mountain Quality Resources, Inc., State College, PA, 1996). BP

[Author Affiliation]

Corresponding author Denise IIis E1. Evans is a technical writer and marketing and sales manager and Jim Erickson is president at Blue Mountain Quality Resources, Inc., a developer of calibration software for FDA and ISO compliance, 208 West Hamilton Avenue, State College, PA 16801, (814) 2342417,fax (814) 234-7077, email calman@coolblue.com.