Control System
What are examples of the elements of Quality Control System and the activities of analytical testing?
Our company will be audited by European Medicines Agency this coming May. They asked, “What are the elements of our quality control system? What are the activities of analytical testing, packaging and component testing?” I have a hard time to understand the content of the questions. I was wondering they expect answers, such as calibration verification, and verification of method performance specifications for the first question, and evaluation of analytical methods for the second. If someone can give me some example, that would be a big help. Thanks.
Yes, you need help fast and this space does not contain enough room to answer everything that you need to get ready for – however, maybe I can get you started –
I am an IRCA QMS 2000 Lead Auditor and very much understand what is being ask!
First – reference materials that you should be aware of:
European Quality Award – http://www.efqm.org/
Malcolm Baldrige National Quality Award – http://www.quality.nist.gov/
ISO – Quality Management System (QMS) 9000 series – http://www.iso.org/iso/home.htm
American Society for Quality (ASQ) – http://www.asq.org
The EFQM and Baldrige are quality awards – these look at the best of the best organizations.
ISO (International Organization for Standardization) standards (which is similar to what you are going through) is set up on a base level that any company or organization should be able to meet.
Your goal should be to get somewhere between what the standards are asking for and the top-level quality awards. The probability is that your organization is already doing a lot of thing very good – also called customer satisfaction.
Now for the quality control system (also called a quality management system). The ISO 9000 series breaks this up into five categories: Quality Manual; Quality Management; Resource Management; Product Realization and the Measurement System. The auditors want to first see what type of a documented system you have to control the overall processes for the business that you are in.
So if you are making some kind of a widget, how has your organization planned to produce what is wanted by the customer, the steps that are gone through to actually make the widget including any product testing of supplier parts or actual components and how the widgets are packaged, shipped and delivered to the customer so that no damage is done to the widget. Once all that is done, how do you know that the customer likes what you sold to them?
Ideally, what you need is some form of documentation (keep is as simple as possible) using the outline of the ISO 9001:2008 below
4 Quality management system
4.1 General requirements
4.2 Documentation requirements
4.2.1 General
4.2.2 Quality manual
4.2.3 Control of documents
4.2.4 Control of records
5 Management responsibility
5.1 Management commitment
5.2 Customer focus
5.3 Quality policy
5.4 Planning
5.4.1 Quality objectives
5.4.2 Quality management system planning
5.5 Responsibility, authority and communication
5.5.1 Responsibility and authority
5.5.2 Management representative
5.5.3 Internal communication
5.6 Management review
5.6.1 General
5.6.2 Review input
5.6.3 Review output
6 Resource management
6.1 Provision of resources
6.2 Human resources
6.2.1 General
6.2.2 Competence, awareness and training
6.3 Infrastructure
6.4 Work environment
7 Product realization
7.1 Planning of product realization
7.2 Customer-related processes
7.2.1 Determination of requirements related to the product
7.2.2 Review of requirements related to the product
7.2.3 Customer communication
7.3 Design and development
7.3.1 Design and development planning
7.3.2 Design and development inputs
7.3.3 Design and development outputs
7.3.4 Design and development review
7.3.5 Design and development verification
7.3.6 Design and development validation
7.3.7 Control of design and development changes
7.4 Purchasing
7.4.1 Purchasing process
7.4.2 Purchasing information
7.4.3 Verification of purchased product
7.5 Production and service provision
7.5.1 Control of production and service provision
7.5.2 Validation of processes for production and service provision
7.5.3 Identification and traceability
7.5.4 Customer property
7.5.5 Preservation of product
7.6 Control of monitoring and measuring devices
8 Measurement, analysis and improvement
8.1 General
8.2 Monitoring and measurement
8.2.1 Customer satisfaction
8.2.2 Internal audit
8.2.3 Monitoring and measurement of processes
8.2.4 Monitoring and measurement of product
8.3 Control of nonconforming product
8.4 Analysis of data
8.5 Improvement
8.5.1 Continual improvement
8.5.2 Corrective action
8.5.3 Preventive action
Again, this is your starting point. The next thing will be to show the auditors how you are continually improving the companies system to do better!
|
|
SUPER NINTENDO SNES SYSTEM & CONTROLLER(rare,console) $36.00 |
|
|
PC-Engine ( PCE ) PI-PD6 CONTROLLER NEC HE SYSTEM JAPAN $22.00 |
|
|
ATARI JOYSTICK CONTROLLER BY CHAMP – 2600/7800/COMMODORE GAME SYSTEMS – RARE! $39.95 |
|
|
RFID Proximity Door Lock Access Control System +10 Keys $13.78 |
|
|
iLive iJ328 CD+G Karaoke Machine System w/ Remote Control & iPod Dock $26.99 |
|
|
Planet Waves Humidipak Humidity Control System Black $19.99 |
|
|
CONTROL SYSTEM DESIGN. C J Savant HC $12.00 |
|
|
Outdoor PT Drive w/ RS485 Controller for DVR system-77B $115.00 |
|
|
Wireless&Wired GSM Alarm System Intercom Monitoring Long-range Control $94.99 |
|
|
15 PC VTECH VSMILE SYSTEM+2 CONTROLLERS+GAMES+EXPLORE GLOBE. FEW IN ORIGINAL BOX $80.00 |
|
|
Super Nintendo System with 2 Controllers and Super Mario World $64.99 |
|
|
Motorcycle Security Alarm System Remote Control Engine Start $0.99 |
|
|
Motorcycle Security Alarm System Remote Control Engine Start $18.00 |
|
|
Sony Audio System Remote Control RM-SEP30 $4.95 |
|
|
20 Wired CONTROLLERS LOT FOR PS2 PLAYSTATION 2 System -DualShock 2 ALL BRAND NEW $5.00 |
|
|
Staefa Control System SE2TV New $100.00 |
|
|
Ge 45129 Wireless Alarm System Control Center Ge $39.75 |
|
|
SHARP RRMCG0318AWSA audio system Remote Control $22.99 |
|
|
Wireless Home Security System With Remote Control $200.00 |
|
|
Modern Control Systems by Richard C. Dorf, Robert. 11E $45.95 |
|
|
xbox game system with two wired controllers with two cabelas games $40.00 |
|
|
2x System Nunchuck Controller For Nintendo Wii $8.99 |
|
|
IR Repeater infrared remote control system compact DC4E $20.99 |
|
|
DAIWA SEALINE LD50H LEVER DRAG SYSTEM CAST CONTROL JAPAN $40.25 |
|
|
Nintendo 64 Grape Purple System Two Matched Controllers, NTSC Cables lot bundle $117.44 |
|
|
SEAGAR CONTROL SYSTEMS MCE-1004202 OPERATOR INTERFACE BOARD MS32 KEYBOARD $100.00 |
|
|
RCA RS 2764 AUDIO SYSTEM REMOTE CONTROL RS2764 $9.95 |
|
|
Sony Play Station 2 – System, Games, and Controllers $69.99 |
|
|
Nintendo GAMECUBE Console LOT System controller GAME MEMORY CARD Disney Naruto $79.95 |
|
|
RGB Wireless IR System : 24Key IR remote controller + IR Receiver + DC Wire $3.25 |
|
|
IonGen G2 Replacement Probe -for Aquascape Ion Gen 2 algae control system-95016 $99.50 |
|
|
RCA 176D8953 AUDIO SYSTEM REMOTE CONTROL RP7929 $7.25 |
|
|
CPI ModBlock PID CONTROLLER for METAL DIGESTION SYSTEM $1,999.99 |
|
|
IR Motion Sensor home Security Alarm system /2 Remote Control for Home Garage K8 $0.99 |
|
|
Bose 402C Systems Controller $88.00 |
|
|
RFID Proximity Door Entry Lock Access Control System $5.89 |
|
|
Controller Gamepad Joystick for super N64 Game System $5.49 |
|
|
6-axis Merlin American Robot MR6240 w/ Controllers & AARM Motion Control System $4,999.99 |
|
|
InFocus Systems LitePro LS Original Remote Control $21.00 |
|
|
Sony RM-S3300 Audio System Remote Control FAST $4 SHIP $40.00 |
|
|
Scott PFX78 7 Inch Digital Photo Frame w Built In Speaker System Remote Control $69.80 |
|
|
SEGA GENESIS SYSTEM MK-1631 W 4 GAMES, 2 CONTROLS TESTED! LOOK! $24.99 |
|
|
The Original X-BOX Complete System Bundle 10 games & special controller hookups $69.99 |
|
|
Nintendo Entertainment System and Controller, no cords. 5 games included. $9.99 |
|
|
SNES Super Nintendo Console System Lot 2 Controllers 15 Games Mario $68.00 |
|
|
44 Key IR Infrared Remote Control + Receiver System For RGB LED Light Lamp Strip $4.56 |
|
|
AUDIOVOX DVD HOME THEATER SYSTEM REMOTE CONTROL DV1200 DV-1200S DV-1100 $18.95 |
|
|
Professional Termite Control Bait System 15 Station Kit $291.99 |
|
|
2 – 3 zone Honeywell TrueZONE System KIT 2 Heat/2 Cool Zone Control Panel $250.00 |
|
|
RAMSEY 4 BUTTON DILUTION CONTROL SYSTEM NEW IN BOX W/ ALL ASSESSORIES MAKE OFFER $275.00 |
|
|
Vtech V.smile TV Learning System / 2 Controllers / 6 Games $8.49 |
|
|
McIntosh CR10 Audio Multizone Control System Manual & HR 10 Remote $458.89 |
|
|
Corvette Line Loc, C4 C5 C6 brake line lock system – roll control $265.00 |
|
|
Griffin Beacon Universal Remote Control System Device $62.90 |
|
|
SYSTEM 2000 ELECTRONIC CONTROL FSP WILPOOL $29.99 |
|
|
Car Garage/Security Alarm System Remote Control $9.90 |
|
|
Buzztime Home Trivia System Controller Yellow $14.99 |
|
|
NEW white Game Controller For Nintendo 64 N64 System UK $9.99 |
|
|
Verification and Control of Hybrid Systems $30.00 |
|
|
NEW Native Instruments Traktor Pro Kontrol S2 Digital DJ System Control PC/MAC $509.99 |
|
|
POTTER VSA1 CONTROLLER MICROPHONE FOR VSA SYSTEM $394.00 |
|
|
USA VISION SYSTEMS 55CTRLC000 USA CONTROL CENTER SOFTWARE $397.00 |
|
|
DIGITAL SECURITY CONTROLS DSC KIT495-17CP01 ALEXOR SYSTEM KIT W/PC9155 TWO $345.00 |
|
|
KERI SYSTEMS PXL-500P PXL Networkable, Tiger II Control. (MS P $529.00 |
|
|
NAPCO SECURITY SYSTEMS GEMX255 8 TO 255 ZONE HYBRID CONTROL $362.00 |
|
|
KERI SYSTEMS PXL500P TIGER CONTROLLER / PROX $504.00 |
|
|
BOSCH SECURITY SYSTEMS LTC 5136/51 CONTROLLER, W/ 16 OUTPUTS FOR AUTODOMES $599.00 |
|
|
Sanyo VSP9000 SYSTEM CONTROLLER FOR ZOOM CAMERAS $371.00 |
|
|
SAMSUNG OPTO-ELECTRONICS SPC-6000 SYSTEM KEYBOARD CONTROLLER, TO TOUCH SCRE $704.00 |
|
|
AVERMEDIA 60ZACCMSNVD0 system controller $509.00 |
|
|
Infrared Remote Control Repeater 10 Emitters 1 Receiver Kit Hidden System $28.80 |
|
|
SELECT ENGINEERED SYSTEMS SAT3R SAT3 with Dual Relay Control $720.00 |
|
|
KERI SYSTEMS PXL-500W PXL Networkable, Tiger II Control. (Wieg $562.00 |
|
|
INTERNATIONAL ELECTRONICS 0-205600 MAX 3 SINGLE DOOR ACCESS CONTROL SYSTEM $765.00 |
|
|
INTERNATIONAL ELECTRONICS 0-205600 SINGLE DOOR ACCESS CONTROL SYSTEM KIT W/ $765.00 |
|
|
PANASONIC WVCU650 PANASONIC SYSTEM CONTROLLER F/ $897.00 |
|
|
BOGEN LUUDC UNIVERSAL CONNECTION DOORPHONE SYSTEM (CONTROLLER & SPEAKER) $375.00 |
|
|
INTERNATIONAL ELECTRONICS MINI-MAX-3-SYS 1-SINGLE-DOOR-ACESS-CONTROL-SYSTEM $572.00 |
|
|
PANASONIC WV-CU650 SYSTEM CONTROLLER FOR WJ-HD300 -HD500 & -HD200 DVRS $893.00 |
|
|
DIGITAL SECURITY CONTROLS DSC SG-SYSTEM-I SUR-GARD SYSTEM 1 $2,449.00 |
|
|
SONY ELECTRONICS RMNS1000 System Controller for the NSR-1000 $1,562.00 |
|
|
PREMIER WIRELESS AG1950 VIDEO & CONTROL SYSTEM LR 12 VDC $4,489.00 |
|
|
DIGITAL SECURITY CONTROLS DSC SG-SYSTEM-I-IP Sur-Gard System I multi-format $2,296.00 |
|
|
PANASONIC WV-CU950 ETHERNET SYSTEM CONTROLLER FOR WJ-SX850/GX SYSTEM $1,628.00 |
|
|
PANASONIC WVCU950 Ethernet System Controller for WJ-SX850/ $1,635.00 |
|
|
PANASONIC WV-CU650 System Controller f/ WJ-HD300, WJ-HD500 $1,075.00 |
|
|
KERI SYSTEMS EGS750HF Entry Controller Silver Hands Free $1,124.00 |
|
|
DIGITAL SECURITY CONTROLS DSC SG-SYSTEM-II SUR-GARD SYSTEM II SINGLE LINE I $1,153.00 |
|
|
650 Watt 12 V AC Wind Turbine System +Charge Controller $689.00 |
|
|
NAPCO SECURITY SYSTEMS GEMRECV96 96 POINT CRYSTAL CONTROLLED $166.00 |
|
|
NAPCO SECURITY SYSTEMS GEMP801ALPHA 8 ZONE CONTROL PANEL W/RP8LCD $138.00 |
|
|
NAPCO SECURITY SYSTEMS GEMP1632INTROPK 16/32 ZONE CONTROL PANEL W/GEMRP1CAE $191.00 |
|
|
NAPCO SECURITY SYSTEMS GEMP3200 8 to 32 ZONE CONTROL PANEL $145.00 |
|
|
NAPCO SECURITY SYSTEMS GEMACM1D 1 DOOR CONTROL,PCDWINDOWS,GEM-X255 $206.00 |
|
|
NAPCO SECURITY SYSTEMS GEMRECV255 255 POINT CRYSTAL CONTROLLED $236.00 |
|
|
DETECTION SYSTEMS BOSCH AEC-SW2-USE AEC MASTER CONTROL KIT ENGLISH $289.00 |
|
|
NAPCO SECURITY SYSTEMS GEMP9600 8 TO 96 ZONE CONTROL PANEL $290.00 |
|
|
DELUXE SPRAY BARK CONTROL, 1 PACK, DOG TRAINING AIDS, RADIO SYSTEMS CORPORATION, $119.45 |
|
|
ADM1026 Thermal System Management Controller $2.59 |
|
|
NAPCO SECURITY SYSTEMS GEM2D 2ND DOOR CONTROL PLUG-IN MODULE $60.00 |
|
|
EasyLunchboxes 3-compartment Bento Lunch Box Containers (Set of 4) BPA-Free. Easy-Open Lids (Not Leakproof) $13.95 Save time, money, paper, and plastic when you use EasyLunchboxes. No more wasteful baggies or mismatched plastic containers. Now you can pack lunches fast for work or school. Even make homemade “Lunchables®!” Created by a mom of three, these bento-style, 3-compartment containers are designed to be carried upright in the EasyLunchboxes cooler bag (choose from 7 vibrant colors). Container lids stay… |
|
|
Keurig B70 Platinum Brewing System $119.69 The Elite Brewing System is Keurig’s gourmet home brewing made affordable. The Elite Brewing System, the most affordably priced Keurig kitchen brewing system, offers K-Cup® coffee, tea and hot cocoa brewing as the elite choice to any drip coffee maker. The Elite offers two cup sizes for brewing options with the programmable feature of Auto Off. The 48-ounce removable water reservoir holds up to 6… |
|
|
Cuisinart CPK-17 PerfecTemp 1.7-Liter Stainless Steel Cordless Electric Kettle $79.99 This Cuisinart Perfectemp Cordless Electric Programmable Kettle offers latest innovation for this product category%2E Heating water will never be easier with this handsome brushed stainless steel kettle%2E Great for making tea%2C hot chocolate or instant soups%2E It will quickly bring 1%2E75 quarts of water to a boil and then turn itself off%2E… |
|
|
Control System [Explicit] $7.99 … |
|
|
Apollo 13: Music From The Motion Picture $4.39 Apollo 13 Movie Sountrack… |
|
|
NAMCO Time Crisis 3 with Guncon 2 Light Gun $95.00 Time Crisis 3 brings the massive arcade hit to life, with all-new features and gaming modes! GUNCON 2 Light Gun included for superior shooting action… |
|
|
Contech CRO101 Scarecrow Motion Activated Sprinkler $59.99 The Contech Electronics Scarecrow Motion-Activated Sprinkler presents an innovative, humane way to keep pets and wildlife from disturbing your yard and garden without the use of complicated traps or potentially hazardous chemicals. The sprinkler combines a surprise spray of water with unexpected motion and noise to create a safe, effective deterrent to unwanted visitors, helping keep your garden l… |
|
|
Orbit 91213 One-Dial Garden Hose Digital Water Timer $31.99 This automatic garden hose watering kit has a single port for easy, automatic lawn watering. With a single dial, the Orbit 91213 hose faucet timer makes it effortless for you to set the clock, start time, duration and intervals. It features one-touch rain delay for water conservation. It comes with multilingual packaging and the water timer comes preprogrammed with multiple languages. It is constr… |
|
|
Wireless IP Pan/Tilt/ Night Vision Internet Surveillance Camera Built-in Microphone With Phone remote monitoring support(Black) $46.88 Specs: Image Compression Format: M-JPEG standard Image Resolution: VGA(640×480) / QVGA(320×240) Sensor: 1/4 inch CMOS, 300,000 Pixels Light frequency: 50Hz, 60Hz or Outdoor Audio compression: ADPCM Data rate: 802.11b: 11Mbps (Max.), 802.11g: 54Mbps (Max.) Ethernet: One 10/100Mbps RJ-45 Viewing angle: 67? Horizontal Rotating Angle: 0~270? Vertical Rotating Angle: 0~120? Alarm Mode: motion detection… |
|
|
Food, Inc. $6.52 Your steak and chicken may not taste quite the same after you digest all of the information found in this documentary about food production in the United States. Exposing not only the disturbing conditions under which livestock exist prior to their slaughter, the film examines the complex issues surrounding our health and the profits of corporations invested in supplying people with inexpensive (i… |
