מדד OEE

OEE (Overall Equipment Effectiveness) מדד משולב לניתוח יעילות הייצור

במסגרת ניסיוננו הרב בהטמעת מערכות OEE, רצינו לעשות קצת סדר בהבנת המונח OEE ואיך הוא עוזר לארגון. OEE הגדרה OEE  הוא מדד משולב לניתוח יעילות תהליך הייצור, כמו כן הוא מדד אוניברסאלי מקובל למדידת היעילות הכוללת של הציוד. ה-OEE  (מדד משולב לניתוח יעילות תהליך הייצור) לוקח בחשבון מגוון של רכיבי משנה בתהליך הייצור וביניהם זמינות,[…]

HMI
ולידציה – Operation Qualification – OQ- part 2

ולידציה – Operation Qualification – OQ- part 2

This article provide overviews of the main test procedures and verification, and their purposes. This OQ procedure is generic, and relevance of the test procedures and verifications provided below depends on the composition of the system under validation

ולידציה – Operation Qualification – OQ- part 2

ולידציה – Operation Qualification – OQ- part 1

The Operation Qualification (OQ) protocol is part of the validation documentation that covers the verification of the proper operation of the system under validation in the user’s facility. This OQ protocol is generic, and the system may include a PC with Human/Machine Interface (HMI), a Programmable Logic Controller* (PLC), pressure, temperature and humidity transmitters, and other monitoring and control components designed to maintain the user’s facility in proper environmental conditions (temperature, pressure and humidity)

ולידציה -Testing and HW/SW Type and Maturity

ולידציה -Testing and HW/SW Type and Maturity

ולידציה -Testing and HW/SW Type and Maturity – GAMP

Process automation systems generally comprise several elements. Categorizing these elements according to those described in GAMP 4 can assist in targeting testing and validation effort.

ולידציה - GAMP - Test Example - part 3Good Automated Manufacturing Practice (GAMP) - Test ExampleGood Automated Manufacturing Practice (GAMP) - Test Example

ולידציה – GAMP – Test Example – part 2

This article cover the second part of our Good Automated Manufacturing Practice (GAMP) test example. This part will cover the typical test phases for supplier’s application SW Module Testing, supplier’s Module Integration Testing and the supplier’s Integration Testing (cont’d) .

ולידציה - GAMP - Test Example - part 3Good Automated Manufacturing Practice (GAMP) - Test ExampleGood Automated Manufacturing Practice (GAMP) - Test Example
ולידציה - GAMP - Hardware & Software Test Environments

ולידציה – GAMP – Hardware & Software Test Environments

ולידציה – GAMP – Hardware & Software Test Environments.HW can be categorized according to both GAMP 4 HW category (standard or custom) and its function within the test environment.. Test SW can also be categorized according to both GAMP 4 SW category and its function within the test environment