Importance of Calibration

Why Calibration Matters

The concept of equipment calibration is an important one throughout FDA and ISO requirements.  ISO 9001, section 7.6 discusses it in a broad sense, while ISO 17025, “General Requirements for the Competence of Testing and Calibration Laboratories”, is specifically about calibration.  In 21 CFR 820.72, it’s stated that “Calibration procedures shall include specific directions and…

Hammer

Preventive Maintenance

Preventive maintenance is a concept that includes care and servicing of equipment for the purpose of keeping equipment in a satisfactory operating condition.  It is designed to improve equipment life and avoid any unplanned maintenance activities.  This is accomplished through a systematic inspection, detection and correction of any developing failures before they occur.  Preventive maintenance…

Clean Room

Control of Equipment

As part of a company’s quality management system, there must be consideration for the equipment used within the facility.  According to the FDA’s 21 CFR 820, “Each manufacturer shall establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked and maintained.”  They also have the requirement that all inspection, measuring and test…

Network servers

Part 11 Compliance

As computer usage became more mainstream, especially as a way to store records, the FDA received a request from various industries for guidance on the use of electronic signatures and submissions to the FDA.  The FDA’s response to this request was to issue 21 CFR Part 11 in 1997, which covers electronic signatures, records and…

FDA

Supplier Challenge

Anyone has the ability to review the FDA database of 483’s, warning letters and FDA statements.  Upon reviewing that information, there are essentially eight areas where companies are facing challenges in regards to supplier oversight: Confusion between internal and external suppliers – There has always been confusion in determining whether a company’s other site(s) or…

Business people planning

Methods for Supplier Evaluation

There are a number of ways to conduct an evaluation of your suppliers.  To begin with, many organizations create a survey in which they outline various questions pertaining to quality systems.  Some companies consider ISO 9001 certification to be the best representation of control over production and quality, and therefore will evaluate the supplier based…