sop 企业标准操作手册

sop 企业标准操作手册
sop 企业标准操作手册

Hazard Analysis Critical Control Point Standard Operating

Procedures Manual

Clayton County School Nutrition Program

218 Stockbridge Road

Jonesboro, Georgia 30236

678-479-0171

Implemented June 30, 2006as per Public Law 108-265,

Section 9(h) of the Richard B. Russell National School Lunch Act

Hazard Analysis Critical Control Point

HACCP Standard Operating Procedure

Section 111 of the 2004 Child Nutrition and WIC (Women, Infants and Children) Reauthorization Act (Public Law 108-265) amended section 9(h) of the Richard B. Russell National School Lunch Act, included a new requirement for School Food Authorities (SFAs) to implement a documented School Food Safety Management System that includes HACCP Standard Operating Procedures (SOPs) based on the process approach to core Hazard Analysis and Critical Control Point (HACCP) principles. The Act mandates that local SFAs “implement the food safety program during the 2005-2006 school year.”

HACCP is a systematic approach to construct a food safety program designed to reduce the risk of foodborne hazards by focusing on each step of the food preparation process---from receiving at the back dock to service to the students and other customers.

Serving safe food is a serious and critical responsibility for our nutrition and food service professionals and is a key aspect of a healthy school environment. Keeping foods safe is also a vital part of healthy eating and is a recommendation of the 2005 Dietary Guidelines for Americans. When properly implemented, HACCP-based food safety programs will help ensure the safety of the school meals served to children and other customers in the Clayton County Public Schools.

List of HACCP Standard Operating Procedure

A. Holding, Serving and Transporting of Food

A1. Cooling Food

Describes acceptable methods of safely cooling foods

A2. Holding Foods

Describes procedures for safely holding hot and cold foods

A3. Service of Food

Describes procedures for safely serving food

A4. Service Temperature

Describes procedures for monitoring temperature of hot and cold food items service

A5. Transportation of Foods

Describes procedures necessary to safely transport food from kitchen to a satellite unit and back following service

A6. Preventing Contamination at Food Bars

Describes procedures for preventing contamination at food bars

A7. Sack Lunches

Describes procedures for safely preparing and serving sack lunches at school.

A8. Using Suitable Utensils When Handling Ready-to-Eat Foods

Describes procedures for using utensils when handling ready-to-eat food

B. Maintenance

B1. Facility and Equipment Maintenance

Describes foodservice facilities and equipment that should be monitored and maintained to ensure food safety

C. Miscellaneous

C1. Calibration of Thermometers

Describes methods for calibrating thermometers

C2. Food Safety in Emergency Situations

Describes basic procedures affecting food safety to be considered during emergencies

C3. Ice Machine Usage

Describes how ice must be used and handled safely

C4. Responding to a Food borne Illness Complaint

Describes procedures to follow if a food borne illness complaint is received by foodservice

C5. Responding to a Physical Hazard Complaint

Describes procedures to follow if a complaint of a physical hazard in food is received by foodservice.

C6. Date Marking Ready-To-Eat Potentially Hazardous Food

Describes procedures to follow for dating food

C7. Visitors in Foodservice

Describes food safety procedures to be followed by all visitors in food product areas

D. Personal Hygiene

D1. Employee Health and Personal Hygiene

Describes personal hygiene practices to ensure food safety

D2. Breaks and Meals

Describes how and where food service employees will take break and meals

D3. Contact with Blood and Bodily Fluids

Describes foodservice procedures dealing with blood and bodily fluid contact

D4. Eating and Drinking in the Workplace

Describes personal hygiene practices to ensure food safety

D5. Glove and Utensil Use

Describes proper use of gloves and utensils in Foodservice

D6. Double Hand washing

Describes procedures for hand washing in foodservice

E.Pest Control

E1. Pest Control

Describes the use of an integrated pest management program (IPM) to control pests in foodservice

F. Preparation

F1. Preparing Cold Foods

Describes procedures for safely preparing cold foods

F2. Thawing Foods

Describes procedures for safely thawing frozen foods

F3. Washing Fruits and Vegetables

Describes procedures for safely washing fruits and vegetables

G.Production

G1. Preparing and Cooking Hot Foods

Describes procedures for safely preparing and cooking hot foods

G2. Reheating Foods (Leftovers)

Describes procedures for safely reheating foods, including leftovers

G3. Tasting Method

Describes the two-spoon method of tasting foods

G4. Use of Thermometers

Describes how and when thermometers can be used effectively during food production and service H.Purchasing

H1. Purchasing

Describes procedures to ensure safe purchase of food

I.Receiving

I1. Receiving Food

Describes procedures for safely receiving foods at delivery, whether frozen, refrigerated, or dry items J.Sanitation

J1. Cleanliness and Sanitation of the Cafeteria

Describes food safety procedures to be used before, during, and after meal service in the school cafeteria J2. Laundry and Linen Use

Describes the use and care of laundry and linens used in school foodservice

J3. Equipment Cleaning and Sanitizing

Describes how equipment with removable parts should be cleaned and sanitized after each use

J4. Machine Ware washing

Describes how to use the high temperature sanitizing dish machine, document its operation, and maintain it after use

J5. Manual Ware washing

Describes how to set up and use sinks designated for manual ware washing, including chemical sanitizer concentrations

J6. Cleaning and Sanitizing Food Contact Surfaces

Describes how to clean food contact surfaces

K.Storage

K1. Storage

Describes procedures for safely storing foods, whether in frozen, refrigerated, or dry storage

L.Training

L1. New Employee Orientation

Describes food safety orientation procedures for new employees.

M.A ppendix

M1. Sample Vendor Letter

M2. Cooling Temperature Log

M3. Food Safety Checklist

M4. Thermometer Calibration record

M5. References

HACCP Standard Operating Procedure

_____________________________________________________________

A1. Cooling Foods

Policy: When cooked food will not be served right away (or is left over and can be saved), it must be cooled as quickly as possible to prevent microbial growth. Temperatures will be taken during the cooling process to make sure that time and temperature standards are met to ensure the safety of food served to children.

Procedures: There are two acceptable methods of cooling foods outlined below. Employees involved in the cooling process of food must observe the following procedures:

One-stage (four hour) method:

1.Cool hot cooked food from 135oF to 70o within 6 hours, provided that food is cooled from 135o to

70o in less than or equal to 2 hours, and food is cooled from 70o to less than 41oF within the

remaining time.

2.Take temperatures at 4 hours to make sure that the appropriate temperature was reached.

3.Reheat food to 165o F for 15 seconds if food has not cooled to 41oF in 4 hours.

4.Chill prepared, ready-to-eat foods such as Tuna Salad and cut melons from 70oF to 41oF or below

within four hours. Take corrective action immediately if ready-to-eat food is not chilled from 70o to

41oF or below within four hours.

Two-stage method (*recommended by the FDA Food Code):

1.Cool hot cooked food from 135oF to 70oF or lower within 2 hours, and then cool down to 41oF or

lower within an additional four 4 hours, for a total cooling time of 6 hours.

2.Take temperatures at the 2 and 6 hour intervals to make sure that appropriate temperatures were

reached.

3.Within 2 hours, reheat food to 165o F and hold for 15 seconds if food is not cooled from 135o to 70o

within less than 2 hours or from 70o to 41oF in the remaining time.

*NOTE: The reason that the two-stage method allows 6 hours to cool is that the food passes through the most dangerous part of the temperature danger zone – where the growth of microorganisms is ideal – during the first 2 hours of cooling.

Factors that affect how quickly foods will cool down:

1.Size of the food being cooled – the thickness of the food or distance to its center plays the biggest

part in how fast a food cools.

2.Density of the food – the denser the food, the slower it will cool.

3.Container in which a food is stored – stainless steel transfers heat from foods faster than plastic.

Shallow pans allow the heat from food to disperse faster than deep pans.

Food may not move through the temperature danger zone fast enough if the food is still hot when placed in the cooler or freezer. The hot food may also raise the temperature of the surrounding food items, placing them in the temperature danger zone (between 41-135°F.). Always wait until hot foods have cooled to less than 135obefore placing them in the cooler.

Listed below are a few methods that can be used to cool foods more quickly. The methods can be used alone or in combination in order to cool foods quickly.

Methods for cooling foods:

1.Reduce the quantity of the food being cooled. Cut large food items into smaller pieces or divide

large containers of food into smaller containers.

https://www.360docs.net/doc/cc5500111.html,e ice-water baths. Divide cooked food into shallow pans or smaller pots then place them in ice

water. Stir food items frequently.

3.Add ice or water as an ingredient. This works for foods that contain water as an ingredient, such as a

soup or stew. The recipe can initially be prepared with less water than is required. Cold water or ice

can then be added after cooking to cool the product and to provide the remaining water required in

the recipe.

4.Stir foods to cool them faster and more evenly. Ice paddles (plastic paddles that are filled with

water and frozen) and chill sticks can be used to stir foods through the cooling process. Stirring food

with these cold paddles chills foods very quickly.

5.Pre-chill ingredients and containers used for making bulk items such as salads.

Monitoring:

https://www.360docs.net/doc/cc5500111.html,e a clean, sanitized, and calibrated probe thermometer suitable for the food being tested, to

measure the internal temperature of the food during the cooling process. A bi-metallic stem

thermometer is adequate for stews, casseroles, and dishes with a lot of liquid. A thermocouple or

thermistor thermometer is needed for meats and poultry.

2. Monitor temperatures of products every hour throughout the cooling process by inserting a probe

thermometer into the center of the food and at various locations in the product.

Corrective Action:

1.Retrain any foodservice employee found not following the procedures in this SOP.

2.Reheat cooked, hot food to 165 oF for 15 seconds and start the cooling process again using a

different cooling method when the food is:

a.Above 70 oF and greater than 2 hours into the cooling process; and

b.Above 41 oF and 6 hours or less into the cooling process.

3.Discard cooked, hot food immediately when the food is:

a.Above 70 oF and more than 2 hours into the cooling process; or

b.Above 41 oF and more than 6 hours into the cooling process after the food has reached 70o

within the first 2 hours.

https://www.360docs.net/doc/cc5500111.html,e a different cooling method for prepared ready-to-eat foods when the food temperature does not

reach 70o within 2 hours and/or if the food does not reach 41 oF in a total of 6 hours.

5.Discard prepared ready-to-eat foods when the food is above 41 oF and more than 6 hours into the

cooling process

Verification and Recordkeeping:

1.Foodservice employees will record temperatures and corrective actions taken on the Cooling

Temperature Log.

2.Foodservice employees will record if there are no foods cooled on any working day by indicating

“No Foods Cooled” on the Cooling Temperature Log.

3. The foodservice manager will verify that foodservice employees are cooling food properly by

visually monitoring foodservice employees during the shift and reviewing, initialing, and dating the

temperature log each working day.

4. The Cooling Temperature Logs are to be kept on file for a minimum of 1 year.

Cooling Foods Procedure: (additional section)

Procedure to follow when cooling of food is not completed prior to food employees leaving the kitchen for the day.

1.Follow a pre-determined method for cooling the food product. This method is one that has been

determined to adequately cool the food from 135° - 41°F within 6 hours with 135° - 70°F being

reached within the first 2 hours.

2.Document the time that food is removed from a heat source and the time that it reaches 135°F or below.

3.The last food employee to leave the kitchen for the day should check the temperature of the food and

document the time and temperature. If the food has been cooling for more than 2 hours and is not ≤70°F, the food must be discarded.

4.If food is not ≤ 41°F, but the total cooling time has not exceeded 6 hours, the food must be left under

refrigeration, following the predetermined method for cooling.

5.Upon returning to the kitchen the next morning, a food employee should check the temperature of all

foods left cooling the prior business day to assure that all temperatures are ≤41°F.

6.If any food is not ≤41°F when the temperature is checked the next morning, it must be discarded.

7.Securely cover all foods that have successfully reached 41°F.

Standard Operating Procedure

_____________________________________________________________

A2. Holding Foods

Policy: All hot foods will be held hot (above 135oF) and cold foods will be held cold (below 41oF). Foods temperatures will be taken during holding to ensure the safety of food served to children. When in doubt about the safety of food, it will be discarded.

Procedures: Employees involved in the production or service of food must:

Holding Hot Foods:

1.Prepare and cook only as much food as is needed. Batch cooking is ideal for maintaining food

temperature and quality.

https://www.360docs.net/doc/cc5500111.html,e hot holding equipment that can keep hot foods at 135oF or higher.

3.Follow manufacturer’s instructions in using hot-holding equipment.

4.Steam table wells need to be filled with hot water to an appropriate level.

5.Keep foods covered to retain heat and to keep contaminants from falling into food.

6.Measure internal food temperatures at least every 2 hours using a probe or stem thermometer.

Record temperatures in a food temperature log.

7.Reheat foods only in appropriate cooking equipment (oven, steamer, microwave, steam-jacketed

kettle) to 165oF and holding for 15 seconds within 2 hours, then transfer to holding equipment. Hot

holding equipment should never be used to heat or reheat foods. Foods may be reheated more than

once, as long as foods are cooled properly; however, check food quality, and discard if quality is

compromised due to reheating.

8.Discard hot foods after 4 hours if they have not been properly held at or above 135oF.

9.Do not mix freshly prepared foods with foods being held for service to prevent cross contamination.

Holding Cold Foods:

https://www.360docs.net/doc/cc5500111.html,e cold holding equipment that can keep cold foods at 41oF (5oC) or lower.

2.Measure internal food temperatures at least every two (2) hours using a calibrated thermometer.

Record temperatures in a food temperature log.

3.Protect cold foods from contaminants with covers or food shields.

4.Place cold foods in pans or on plates first, never directly on ice. The only exceptions are whole

fruits and vegetables. Wash and sanitize drip pans after each use.

Monitoring:

https://www.360docs.net/doc/cc5500111.html,e a clean, sanitized, and calibrated probe thermometer suitable for the food being tested, to

measure the internal temperature of the food during the cooling process. A bi-metallic stem

thermometer is adequate for stews, casseroles, and dishes with a lot of liquid. A thermocouple or

thermistor thermometer is needed for meats and poultry.

2.Monitor temperatures of products every hour throughout the cooling process by inserting a probe

thermometer into the center of the food and at various locations in the product.

3.Take temperatures of foods by inserting the thermometer near the surface of the product, at the

thickest part, and at other various locations.

4.Take temperatures of holding units by placing a calibrated thermometer in the coolest part of a hot

holding unit or warmest part of a cold holding unit.

5.For hot foods held for service:

a.Verify that the air/water temperature of any unit is at 135oF or above before use.

b.Reheat foods in accordance with the Reheating for Hot Holding SOP.

c.All hot potentially hazardous foods should be 135 oF or above before placing the food out for

display or service.

d.Take the internal temperature of food before placing it on a steam table or in a hot holding

unit and at least every 2 hours thereafter.

6.For cold foods held for service:

a.V erify that the air/water temperature of any unit is at 41 oF or below before use.

b.Chill foods, if applicable, in accordance with the Cooling Potentially Hazardous Foods SOP.

c.All cold potentially hazardous foods should be 41oF or below before placing the food out for

display or service.

d.Take the internal temperature of the food before placing it onto any salad bar, display cooler,

or cold serving line and at least every 2 hours thereafter.

7.For cold foods in storage:

1.Take the internal temperature of the food before placing it into any walk-in cooler

or reach-in cold holding unit.

2.Chill food in accordance with the Cooling Potentially Hazardous Foods SOP if

the food is not 41oF or below.

3.Verify that the air temperature of any cold holding unit is at 41oF or below before

use and at least every 4 hours thereafter during all hours of operation. Corrective Action:

1.Retrain any foodservice employee found not following the procedures in this SOP.

2.For hot foods:

? Reheat the food to 165 oF for 15 seconds if the temperature is found to be below 135oF and the last temperature measurement was 135oF or higher and taken within the last 2 hours.

Repair or reset holding equipment before returning the food to the unit, if applicable.

? Discard the food if it cannot be determined how long the food temperature was below 135oF.

3.For cold foods:

? Rapidly chill the food using an appropriate cooling method if the temperature is found to be

above 41oF and the last temperature measurement was 41oF or below and taken within the last 2

hours:

?Place food in shallow containers (no more than 2 inches deep) uncovered on the top shelf in

the back of the walk-in or reach-in cooler.

?Use a quick-chill unit like a blast chiller.

?Stir the food in a container placed in an ice water bath.

?Add ice as an ingredient.

?Separate food into smaller or thinner portions.

4. Repair or reset holding equipment before returning the food to the unit, if applicable.

5. Discard the food if it cannot be determined how long the food temperature was above 41°F. Verification and Record Keeping:

1.Foodservice employees will record temperatures of food items and document corrective actions

taken on the Service Temperature Log.

2. A designated foodservice employee will record air temperatures of coolers and cold holding units

on the Equipment Temperature Logs every 4 hours during all hours of operation.

3.The foodservice manager will verify that foodservice employees have taken the required holding

temperatures by visually monitoring foodservice employees during the shift and reviewing the

temperature logs at the close of each day.

4.The temperature logs are to be kept on file for a minimum of 1 year.

Service Temperature Log

Please report readings that do not fall in the optimal ranges to the unit supervisor. Corrective action must be noted if temperatures fall outside of appropriate range.

HACCP Standard Operating Procedure

_____________________________________________________________

A3. Service of Food

Policy: All food is served in a sanitary manner to ensure food safety and prevent food borne illness.

Procedures: Only nutrition employees trained in proper sanitation and safety procedures are allowed in the food production area. Employees involved in the service of food must observe the following procedures to ensure its safety:

Good personal hygiene:

1.Wash hands before handling utensils, dinnerware, trays, food, etc.

2.Do not touch cooked or ready-to-eat foods with bare hands. Use gloves or utensils.

3.Wash hands between each different task. For example, if the same employee is loading dirty dishes

and taking out clean dishes, a thorough hand washing must be done between the two tasks.

4.Do not eat in food production or service areas unless taste testing foods (see G.3 SOP). A beverage

is allowed in the food service area provided the cup has a lid and a straw, and it is stored below the

prod uction area, such as on a shelf below the table to ensure it won’t fall and contaminate the food

being prepared.

5.Wash hands before putting on gloves and each time gloves are changed.

6.For more detailed instructions refer to SOP on Personal Hygiene Section D

Service utensils and service ware:

1. Clean and sanitize utensils before using them. Use separate utensils to serve

each food item.

2. Store utensils properly with the handle extended above the container, or on a

clean and sanitized food-contact surface.

3. Use serving utensils with long handles to keep hands away from the food

item.

4. Handle all glassware without touching outer or inner rim. Trays and dishes

should be handled by the bottom or outer rim only. Avoid touching any

surface that may contact food. Trays should be stored bottom up

5. Hold flatware and utensils by the handles.

Cleaning/sanitation:

1.Clean the area on and around the service line, using warm soapy water and clean cloths. Thoroughly

rinse area after cleaning.

2.Sanitize the area on and around the service line, using an approved sanitizer.

3.Maintain area cleanliness before service begins and as needed throughout service.

https://www.360docs.net/doc/cc5500111.html,e only designated cloths for cleaning food spills.

Service:

1.Take temperatures of foods at the beginning of each service period.

2.Hold potentially hazardous food at the proper temperature.

3.Date mark and cool potentially hazardous foods or discard leftovers.

4.Once a potentially hazardous food has been served, even in a commercial wrapper that has been

unopened, the food cannot be retrieved, reserved and/or reused for any reason.

Monitoring:

1. A designated foodservice employee will visually observe that food is being served in a manner that

prevents contamination during all hours of service.

Corrective Action:

1.Retrain any foodservice employee found not following the procedures in this SOP.

2.Replace improperly handled plates, cups, or utensils with clean items.

3.Discard ready-to-eat food that has been touched with bare hands.

4.Follow the corrective actions identified in the Washing Hands; Using Suitable Utensils When Handling

Ready-To-Eat Foods; Date Marking Ready-to-Eat, Potentially Hazardous Foods; Cooling Potentially Hazardous Foods; and Holding Hot and Cold Potentially Hazardous Foods SOPs.

Verification and Recordkeeping:

1.The foodservice manager will periodically check the storage and use of utensils during service.

2. The foodservice manager will complete the Food Safety Checklist daily.

3. The Food Safety Checklist is to be kept on file for a minimum of 1 year.

A4. Service Temperatures

Policy: Temperatures of all hot and cold foods are taken during service to ensure that foods are maintained at appropriate temperatures to ensure the safety of food served to children. Procedures: Employees who will be setting up the service line and serving food must follow these procedures:

https://www.360docs.net/doc/cc5500111.html,e a calibrated thermometer to take temperatures of food products.

2.Wipe the thermometer stem with a new alcohol wipe or other approved sanitizing method prior to

taking the temperature of any food item and allow dry airing.

3.Take temperatures of all hot foods as soon as they are put on the serving line.

4.Take temperatures of all cold foods as they are put on the serving line or salad bar.

5.Take temperature of milk before the serving line begins.

6.Record all temperatures on the Service Temperature Log with employee initial.

7.Verify that all temperatures are within the critical limits:

?Hot foods are at or above 135o F

?Cold foods are at or below 41o F

8.Take corrective action, if needed. If hot foods are below 135o F, they must be heated to above 165°F

and held 15 seconds before serving. If cold foods are above 41o F, they must be chilled to below

41o F before serving.

9.Give the Service Temperature Log to the manager.

Monitoring:

https://www.360docs.net/doc/cc5500111.html,e a clean, sanitized, and calibrated probe thermometer to measure the internal temperature of the

food at the beginning of the serving period.

2.Monitor temperatures of products every hour throughout the serving period by inserting a probe

thermometer into the center of the food and at various locations in the product.

Corrective Action:

1.Retrain any foodservice employee found not following the procedures in this SOP.

2.Remove foods from serving line whose temperatures are not within the critical limits.

3.If hot foods are below 135o F, they must be heated to above 165°F and held for 15 seconds before

serving.

4.If cold foods are above 41o F, they must be chilled to below 41o F before serving.

Verification and Record Keeping:

1.Monitor the logs to ensure that they are completed and that the temperatures are appropriate.

2.Review the log to see if there were temperature deviations.

3.Check corrective action taken to determine if it was appropriate.

4.Follow up as necessary.

5.Keep logs on file for 1 year.

A5. Transportation of Foods from Central or Regional Kitchens

to Satellite Locations

Policy: Food will be transported in a manner to ensure its quality and safety.

Procedures: Employees involved in the production or transportation of food from a central or regional kitchen to a satellite location must be responsible for the safety of food handled. Steps include:

1.Preheating holding equipment.

2. Calibrating thermometers each week or sooner, if dropped or inaccurate.

3. Using calibrated thermometers to take food temperatures.

4. Recording temperature and time in Service Temperature Log with employee’s initial. The Service

Temperature Log shall follow the food (one [1] log).

Prior to transport, employees at central or regional kitchen should:

1. Take temperature of food prior to loading. Hot foods should be at or above

135oF and cold food should be at or below 41oF.

2.Record temperatures on log and initial the entry.

Employees at Satellite Location:

1. Take and record food temperatures upon arrival at the satellite location.

Employee should initial entry.

2. Take and record temperature of food before it is returned to the central kitchen

if leftover food is not discarded. Employee should initial entry.

Following return of transport, employees at central kitchen should:

1. Take and record temperature of food and employee initials upon return from a

satellite location.

2. Discard cold foods that are not at or below 41oF and hot foods that are not

at or above 135oF.

3.Cool hot cooked food that is at or above 135°F. The product must be cooled to 70°F in 2 hours from

the last 135°F reading. If food temperature has not reached 70°F within 2 hours, dispose of the food.

Recommended procedure is cooling food to 70°F within 2 hours and to 41°F within 4 additional

hours.

4.Record the product name, date, temperature, and time on the product.

5.Store chilled food in refrigerator or freezer.

The unit supervisor will:

1.Review logs daily to ensure the temperatures and corrective actions are being met.

2.Follow up as necessary.

3.File temperature logs in HACCP file.

A6. Preventing Contamination at Food Bars

Policy: To prevent food borne illness by ensuring that all items held on food bars are protected from contamination.

Procedures: This procedure applies to anyone who is responsible for maintaining and monitoring the self-service food bars.

1.Train foodservice employees on using the procedures in this SOP.

2.Follow State or local health department requirements.

3.Follow Employee Health Policy, Personal Hygiene, and Washing Hands SOPs. (Employee health

policy is not included in this resource.)

4.Follow manufacturer’s instructions for pre-heating and pre-chilling food bar equipment before use.

5.Place all uncovered food under sneeze guards.

6.Provide an appropriate clean and sanitized utensil for each container on the food bar. The handle of

the utensil must be longer than the widest width or depth of the pan to avoid the utensil slipping down into the food.

7.Replace existing containers of food with new containers when replenishing the food bar.

8.Assist customers who are unable to properly use utensils.

9.Ensure that customers use a clean dish when returning to the food bar.

10. Store eating utensils with the handles up or in a manner to prevent customers from touching the food

contact surfaces.

11. Avoid using spray chemicals to clean food bars when in use.

Monitoring:

1.Monitor and record temperatures of food in accordance with the Holding Hot and Cold Potentially

Hazardous Foods SOP.

2.Continually monitor food containers to ensure that utensils are stored on a clean and sanitized

surface or in the containers with the handles out of the food.

3.Monitor personnel to be sure old containers are replaced with new.

4.Continually monitor customers’ use of the food bar to ensure that customers are not:

?Touching food with their bare hands

?Coughing, spitting, or sneezing on the food

?Placing foreign objects in the food

?Using the same plate for subsequent trips

Corrective Action:

1.Retrain any foodservice employee found not following the procedures in this SOP.

2.Remove and discard contaminated food.

3.Demonstrate to customers how to properly use utensils.

4.Discard the food if it cannot be determined how long the food temperature was above 41oF or

below 135oF.

Verification and Recordkeeping:

1.The foodservice manager will verify that foodservice employees are assigned to maintain food bars

during all hours of operation.

2.Foodservice employees will record temperatures of food items and document corrective actions

taken on the Hot and Cold Holding Temperature Log.

3.The foodservice manager will complete the Food Safety Checklist daily. This form is to be kept on

file for a minimum of 1 year.

4.The foodservice manager will document any discarded food in the food production record.

A7. Sack Lunches

Policy: Foodservice employees and teachers/school staff will work together to ensure that sack lunches served to children are safe to eat.

Procedures: All employees in school foodservice must:

1.Follow all personal hygiene HACCP Standard Operating Procedure.

2.Prepare and store sack lunches according to HACCP Standard Operating Procedure.

https://www.360docs.net/doc/cc5500111.html,e gloves for handling all ready-to-eat foods.

Teachers or school staff who order sack lunches should:

1.Place the order at least two weeks before the event and confirm final count three days prior to the event.

2.Select a menu from options provided.

3.Observe appropriate food handling techniques such as:

a.Wash hands prior to distributing meals.

b.Maintain cold temperatures of food.

c.Discard ALL extra food immediately following the meal. Food will cause illness if it is not kept

at appropriate temperatures. The temperature danger zone is between 41°F and 135°F.

4.Return all equipment to the school foodservice department within 24 hours of the event.

The unit supervisor will:

1.Prepare appropriate menu options.

2.Take order from teacher/staff member.

3.Observe all foodservice employees to ensure that they are following HACCP Standard Operating

Procedure.

4.Accept and inspect returned equipment. If equipment is not returned or is returned damaged, the

teacher/staff member will be billed for the cost of replacing the equipment.

5.Follow up as necessary.

Monitoring:

1.Monitor food service employees to ensure they are following the SOP for production.

2.Provide teachers with a copy of the SOP

3.Monitor temperatures on Service Temperature Log of potentially hazardous foods sent out. Corrective Action:

1.Discard potentially hazardous foods not held at the proper temperature.

2.Retrain where needed.

Verification and Record Keeping:

1.The foodservice manager will verify that foodservice workers are following procedures by visually

monitoring foodservice employees during all hours of operation.

2.The foodservice manager will complete the Food Safety Checklist daily.

3.The foodservice manager will record any discarded food in the food production records.

A8. Using Suitable Utensils When Handling Ready-to-Eat Foods

Policy: To prevent food borne illness due to hand-to-food cross-contamination.

Procedures: Employees who prepare, handle, or serve food should:

1.Follow State or local health department requirements.

2. A double hand wash will be done by all employees in the food preparation area before starting work,

upon reentering the kitchen and after using the restroom (DHR procedures page16 chapter. 290-5-14)

https://www.360docs.net/doc/cc5500111.html,e proper hand washing procedures to wash hands and exposed arms prior to preparing or handling

food or at anytime when the hands may have become contaminated.

4.Wash hands and change gloves:

?Before beginning food preparation

?Before beginning a new task

?After touching equipment such as refrigerator doors or utensils that have not been cleaned and sanitized

?After contact with chemicals

?When interruptions in food preparation occur, such as when answering the telephone or checking in

a delivery

?After handling money

?Anytime a glove is torn, damaged, or soiled

?Anytime contamination of a glove might have occurred

5.Do not use bare hands to handle ready-to-eat foods at any time unless washing fruits and vegetables.

https://www.360docs.net/doc/cc5500111.html,e suitable utensils when working with ready-to-eat food. Suitable utensils may include:

?Single-use gloves

?Deli tissue

?Foil wrap

?Tongs, spoodles, spoons, and spatulas(preferred method)

MONITORING:

1.The foodservice manager will visually observe that gloves or suitable utensils are used and

changed at the appropriate times during all hours of operation.

2.The foodservice manager will visually observe that appropriate hand washing techniques are used. CORRECTIVE ACTION:

1.Retrain any foodservice employee found not following the procedures in this SOP.

2.Discard ready-to-eat food touched with bare hands.

VERIFICATION AND RECORD KEEPING:

1.The foodservice manager will verify that foodservice workers are using suitable utensils by visually

monitoring foodservice employees during all hours of operation.

2.The foodservice manager will complete the Food Safety Checklist daily.

3.The foodservice manager will record any discarded food in the food production record.

B1. Facility and Equipment Maintenance

Policy: The facility and equipment will be maintained to ensure the safety of the food served to children. Procedures: Managers in school foodservice operations must:

1.Monitor the maintenance of toilet facilities so that they function properly and are clean. This includes

verifying that adequate supplies of liquid soap and disposable towels are available at all times.

2.Water temperature should be taken and recorded periodically (monthly) to ensure that water available at

all sinks is “tempered” (100oF - 110oF).

3.Check to make sure that there is no possibility of back siphonage.

a.All hose bibs with threads should have back-siphon protection on it or upstream on the pipe

b.Pre-rinse nozzle at the dishwasher must automatically hang above the sink so that the nozzle is

above the flood rim.

c.Floor drain openings must be at least twice the diameter of any drainage hoses inserted in them;

for example, the ice machine hose.

4.Check to make sure that all food waste and rubbish are stored in rodent and insect-proof containers with

tight fitting lids.

5.Verify that temperatures of all cooling equipment are taken and recorded routinely to ensure proper

calibration of thermometers and proper equipment operation.

6.Verify that temperatures of all heating equipment are taken and recorded routinely to ensure proper

calibration of thermometers and proper equipment operation.

7.Monitor the maintenance of ventilation systems, ensuring that systems are adequate and regularly

cleaned according to the set schedule.

Monitoring:

1.Assure all equipment in the foodservice facility is well maintained.

2.Contract with an equipment repair company or work with the school district’s maintenance department

to have regularly scheduled preventive maintenance done for all equipment. Managers and trained

assistants shall calibrate all thermometers in the department at least once weekly and after being dropped.

3.Log all preventative maintenance.

4.Review temperature logs to ensure that all are being completed and to determine problem areas.

5.Follow up on any equipment issues or needs.

6.Maintain all facility and equipment documentation with HACCP records.

7.Make sure facility is health inspection ready.

Corrective Action:

1.Correct violations immediately.

Verification and Record Keeping:

1.Have two health inspections on file per year.

2.Cleaning schedules maintained and on file for one year.

3.Equipment temperature logs on file for 1 year.

sop操作规程

威世半导体(西安)有限公司中国陕西省西安市西安高新开发区新型工业园信息大道20号文件号:SOP-9 修改号:文件名称:电气检修作业安全操作规程第7 页共8 页3.7.4 高处工作时应用带绳传递物料,不得上下抛掷。 3.7.5 顶棚内工作需要照明时,应用安全灯或手电筒照明,不准使用明火或一般照明。3.8 铅酸蓄电池使用保养注意事项3.8.1 搬运蓄电池,必须使用工具车平稳运送,不得多层放置,应轻拿轻放,不得在地面上拖动,应避免剧烈振动。 3.8.2 蓄电池支架必须牢固可靠,防止打滑倾覆。 3.8.3 紧固端子前,应首先检查端子确保无氧化、断裂、变形。固定螺栓螺母外观检查必须做到六方头部完好、螺纹无损坏。紧固前固定螺栓螺母必须涂抹“抗锈成”防腐润滑剂。 3.8.4 端子固定方向应以保证紧固工具不会碰撞其它端子为宜。 3.8.5 拆装、紧固蓄电池端子时,必须使用合适规格的套筒扳手或呆扳手,注意每次旋转角度不得大于60度,以防电极间短路。 3.8.6 各类连接线、工具、零件不得放置于蓄电池上,以防引起极间短路。3.8.7 端子紧固完毕后,应在其表面涂抹一薄层黄油以防止腐蚀。3.8.8 连接端子时必须注意极性,操作时首先连接正极电缆。 3.8.9 电池拆下时应先关闭浮充电源,静置1h以上再作业,拆下时应避免正负端子打火。 3.8.10 拆卸连接电缆后,必须用绝缘包布包扎电缆裸露铜线部分。保持电池外观清洁,注意及时擦去尘埃与电解液,尤其是接线端子及接线电缆.。注意检查液口栓排气孔是否堵塞。 3.8.11 定期检查液面,如低于低位线,请用蒸馏水或纯净水补注液至上水线,绝不可添加硫酸液。注液后的电池应及时使用,如长期不用,定期进行补充电。 3.8.12 新电池初注液后,应静放置20分钟如液面不下降,则可进行充电,若液位下降,应再次加注。 3.8.13 电池长时间连续放电导致亏电后,应该实施恒流充电。此时,应将液口栓打开排气。充电完毕后,逐渐减小充电电流再切断电源。充电后,电池应静放0.5h 后再将液口栓拧紧。

标准操作规程(SOP)基础知识

标准操作规程(SOP)基础知识 标准操作规程(SOP)是各种标准化管理认证和产品认证的重要内容,各行业都有SOP的要求。什么是SOP?简单的讲,SOP就是一套包罗万象的操作说明书大全。一套好SOP是确保产品或服务质量的必要条件。SOP不仅仅是一套技术性范本,它更重要的涵盖了管理思想、管理理念和管理手段。由于在成熟的行业,都有明确的管理规范和认证体系,因此其SOP的标准化和成熟性都比较高,编写SOP也有依据难度较低。由于目前还没有成熟的实验室管理和认证体系,因此,在检验工作中编写SOP会有些盲然。 首先,SOP具有行业特点,不同的行业都有不同的SOP。就检验工作而言,仪器有仪器的SOP,试剂有试剂的SOP,各个项目有各自不同的SOP,别说是细菌、生化免疫这些学科不同的有不同的SOP,就是同一学科内不同项目也有不同的SOP。所以检验SOP不是一个,而一套。 第二,SOP事无巨细,也就是说只要与项目有关,要详细全面,要包括所有的可能出现的细节。以飞行员操作规程为例,第一条竞然是“坐下”,由此可以看出,SOP涵盖细节程度。SOP不是简单的操作说明,而应该是实用操作大全,应该成为工具书性质的东西。一套理想的SOP 应该让一个不懂的学了后就能成为专家。 第三,SOP不是仅仅是详尽的操作说明,它是管理规范的一部分,也包涵着质量控制和管理理念,从中甚至可以看到人员配置等情况。 虽然不同的行业SOP的具体内容是不同的,但是其是有确实的逻辑联系,因此借鉴其他行业特别相近行业的SOP要求是很有价值的。以药品生产SOP为例,其要求是GMP认证所要求的,根据GMP,其SOP的重点见附。 借鉴药品的SOP的重点,检验SOP应该包涵: 1、操作程序:实验和仪器的操作程序、实验器械的取用和实验后的处理、实验台的清洗、实验物溢漏的处理等 2、质量控制:实验和仪器的质量监控,如实验质控数量(高、中、低?),仪器的校正(人员、时间、方法等)、维护和保养、实验的原始记录等。实验原始记录很重要,发现问题和解决问题的重要手段,除病人资料外,还应有环境参数(天气情况、温湿度等)、使用仪器及仪器情况、样本性状和质量、试剂厂商及批号、同批质控结果以及处理方式(如复查、重抽、发报告)等,尽量详尽。 3、异常结果判断及处理:判断异常结果的指标,及分析处理原因方当及程序。如,是异常给果,还是实验误差或错误?怎么判断?样本正常范围是多少?非正常范围的标本如果处理,大于多少或小于多少复查或与临床联系? 4、流程:应包括样本收发、报告单收发审核、质量和仪器问题处理等

人力资源部SOP(标准操作手册)

人力资源部标准操作程序一览表 序号任务号任务的题目页码 1.TY-EO-SOP-01 代表酒店参加有关会议 2.TY-EO-SOP-02 酒店公章使用程序 序号任务号任务的题目页码 3.TY-EO-SOP-03 酒店行政文件的处理 4.TY-EO-SOP-04 以酒店名义向外发文 5.TY-EO-SOP-05 全店办公设备的调配 6.TY-EO-SOP-06 电话通知的处理 7.TY-EO-SOP-07 安排酒店管理人员会议 8.TY-EO-SOP-08 分发内部报纸 9.TY-EO-SOP-09 办理社会团体来店参观程序 10.TY-EO-SOP-10 接待参观 11.TY-EO-SOP-11 制定酒店工作计划 12.TY-EO-SOP-12 年度总结工作 13.TY-EO-SOP-13 行政例会程序 14.TY-EO-SOP-14 公文制作程序 15.TY-EO-SOP-15 文件资料的归档处理程序 16.TY-EO-SOP-16 文件的查询、借阅程序 序号任务号任务的题目页码 17.TY-EO-SOP-17 电话接听记录的处理程序 18.TY-EO-SOP-18 会客、访客的程序 19.TY-EO-SOP-19 车辆油料填加和审批程序 20.TY-EO-SOP-20 车辆使用程序

21.任务号任务的题目 22.TY-HR-SOP-01 员工招聘程序页码序号TY-HR-SOP-02 员工入职办理程序 1 TY-HR-SOP-03 员工转正考核程序 2 TY-HR-SOP-04 员工晋升调动办理程序 3 TY-HR-SOP-05 员工离职办理程序 4 TY-HR-SOP-06 优秀员工评选程序 5 TY-HR-SOP-07 员工投诉及建议处理程序 6 TY-HR-SOP-08 人事档案建立及保管程序 7 TY-HR-SOP-09 员工社保申报程序 8 TY-HR-SOP-10 员工考勤审核程序 9 TY-HR-SOP-11 员工制服、工鞋及工号牌发放程序 10 TY-HR-SOP-12 员工工资核算程序 11 TY-HR-SOP-13 新员工培训程序 12 TY-HR-SOP-14 在职员工培训程序 13 TY-HR-SOP-15 假期工录用及工资结算程序 14 TY-HR-SOP-16 员工活动组织程序 15 TY-HR-SOP-17 员工宿舍入住程序

客服部操作手册 (sop)

第一章业务受理作业流程 1总则 客服部是客户的代言人,在公司代理客户的一切事务。公司要求客服人员从受理业务开始就要做到一票业务负责到底,要求在业务受理时准确掌握客户下达的指令并进行核实,明确业务要求并引导性的提示客户委托我公司的货物属性,是否有危险品,机场和车站所禁运的货物。 2受理流程 合同客户的受理流程: 2.1客户以邮寄方式下达定单;客户的邮件应包含业务操作及客户要求的所有内容,客服人员接到客户的邮件后,第一时间与客户电话确认核对邮件内容,明确业务要求。需要重点提示客户的是;客户委托我公司所运输的货物是否有危险品,告知客户航空和铁路安检时所禁运的货物类别,并要求对方在《危险货物通知函》上签字确认。 2.2客户以电话方式下达订单;客服接到电话后认真记录客户的业务需求,记录完毕后需复述全部内容与客户再次确认避免因口误造成的的错误。并引导性的提示客户是否有禁运的货物。要求对方在《危险货物通知函》上签字确认。 2.3客户以传真方式下达订单;客户中心人员接到客户传真后,与客户电话确认传真内容,并与客户核对当日订单数量,从而避免因设备和人员原因造成的漏单现象。并告知客户航空和铁路安检时所禁运的货物类别,并要求对方在《危险货物通知函》上签字确人。 2.4新业务的受理流程 a有市场部开发的新业务,在客户部受理之前市场人员都要提供《客户服务交接表》及合同报价,对暂时没有签订合同的客户需要附有关于结算方式、结算时间的协议。 b《客户服务交接表》及协议价格首先需要市场部经理签字确认后,再经公司各部门经理签字审批。针对业务类型,仓储业务需要仓储部经理签字审批,配送业务需要配送经理签字确认审批,最后由总经理签字审批后方可生效,否则客户部不予受理。

SOP操作手册

SOP 操作手冊 一、開機 1.1 UV 燈源 曝光機與UV 燈源為不同的電源供應,故開啟UV 燈源須在機台下方將電源開關另行開啟(如下圖五)。開啟電源後暖機約30秒後,按下START 鈕點燈(按下後放開),UV 燈隨即亮起。 1.2機台操作確認 1、打開機台總電源,確認真空(-22~-25inHG )、空氣壓力(5kgf/cm2)、 是否達到操作標準。 2、確認影像系統正常,螢幕與UV 燈為開啟狀態。 3、確認氣缸位置正常。 ※(電源供應器開機後必須確認風扇是否有正常運轉,如無正常運轉,請立即關閉電源,並通知維修人員。) START 鈕 POWER POWER

二、製程操作 2.1照度測試 按下,即可量測光源強度。(量測順序如下) ※(反之為歸復)2.2取放光罩(Mask Loading) 1.蓋下載台板 2.上升、降下CCD 3.將UV燈往右移 4.開啟燈源閘門

將光罩放置於光罩座上, 對準光罩定位Pin緊密接觸後,開啟光罩真空,確認光罩是否被真空吸附住,有無漏真空。 2.3 參數資料(Data) 光罩定位Pin

輸入完參數後,按下,之後所輸入的參數會顯示在左邊的綠色數字 確定所輸入的參數無誤後,按下 輸入此次製程所需要的參數 檔案名稱選擇鍵 此筆參數資料的名稱 此顯示為Write In 後的參數

※(檔案名稱有0~499筆,可作為存檔用,如下次需要使用同一筆參數資料時,方可使用) ※(控制盒跟觸碰螢幕上的按鍵功能相同,可相互使用) 所 輸 入 的 參 數 資 料 ( 再 次 確 認 ) 檔案名稱搜尋鍵

化学品SOP化学品操作规程

化学品操作规程SOP 一.目的 使作业人员掌握化学品性质及安全(MSDS)、化学品设备CDM、阀门分流箱VMB、化学桶更换操作及应急反应措施,确保化学品房的正常工作及必要的安全保证,特制定本规程。 二.适用范围 本规程适用于本厂化学品设备作业全过程。 三.职责 1.运行巡检人员定时巡检抄表,并熟练掌握CDM控制屏及一些调压阀、流量计的使用与操作,巡检时一旦发现异常,立即通知化学房相关负责人。 2.维护人员(或化学品相关负责人)不仅要掌握CDM、VMB的熟练操作(包括送液、换桶操作),还应对化学品的MSDS非常熟悉,发生化学品泄漏时做出相应的处理。 四.操作 (一)供液操作 1. 首先确保供给工艺机台的液体是酸或碱,确保是满桶,确保抽风已开 (0.2KPa左右);氮封压力满足:不大于0.1MPa;PRG压力:0.3MPa左右(NaOH、KOH、H2SO4的PRG压力在0.4MPa左右);VRG压力:0.5Mpa左右; 2. 穿戴合适的PPE:C级防化服、乳胶手套、防化靴、防毒面具(俗称“猪鼻子”);准备相应的吸收棉; 3. 检查CDM内应打开手动阀是否已经打开(PMV、SMV、FIV、FOV),应打开的气动阀其气动软管是否插上,应关闭的手动阀门是否已关,酸(碱)桶接头是否紧固、管路接头、阀门部件及其连接处有无松动、泄漏,并确认无误; 4.检查VMB管路是否良好,应打开手动阀门(包括进入VMB的主阀及其支路阀门)是否打开、应开气动阀门是否插上气动软管,并确认无误; 5.检查机台的应开手动阀或者气动阀是否打开并确认无误。

6. 一切准备就绪,检查完好,手戴乳胶手套按CDM柜上“Stand By”按钮,让一桶“准备供液”,另一桶“待机”,把供液操作调成自动模式,实现桶空自动切换,保证工艺机台的持续供液。 7. 通知工艺机台负责人所需化学品设备已待机,机台发出信号,CDM就开始自动供液; 8. 送液完成 (二)换桶操作 图示: 注:按下Stand by钮前需要进入报警记录画面恢复空桶报警。 在进行酸(碱)桶更换操作时,务必穿戴合适的PPE 语言描述: 1.当系统发出空桶报警并将空桶下线后,按下静音按钮(Mute钮); 2.穿戴好PPE并准备相应工具 (1)需穿戴的PPE有:C级防化服、防毒面具、乳胶手套、防酸碱手 套、防化靴 (2)需准备的工具有:扳手、丁字形酸碱桶盖拆卸工具、吸收棉、夹 酸车或推酸车(200L桶用)、液压车(1000L桶用) 3.打开CDM们,拆卸酸桶接头并用吸酸棉将其包住放到Coupler盒子 内,盖上桶盖; 4.将空桶从设备中移出,记录空桶编号,将其放到空桶储存区域; 5.用液压车或者推酸车将新桶装入设备中,检查酸碱桶化学品名称是否 正确,记录新桶编号; 6.用扳手缓缓拆卸桶盖并连接好酸桶接头; 7.关闭CDM门;

行政人事部SOP(标准操作手册)

行政办公室标准操作程序一览表 序号任务号任务的题目页码 1.EO-SOP-01 代表酒店参加有关会议 2.EO-SOP-02 盖酒店公章和开具介绍信 3.EO-SOP-03 交换文件(发文) 4.EO-SOP-05 酒店行政文件的登记及传阅 5.EO-SOP-06 以酒店名义向外发文 6.EO-SOP-07 上级工作简报 7.EO-SOP-08 为外籍人员办理来华手续 8.EO-SOP-09 各部门领取办公用品的审批与核算 9.EO-SOP-10 全店办公设备的调配 10.EO-SOP-12 电话通知的处理 11.EO-SOP-13 安排酒店管理人员会议 12.EO-SOP-14 为酒店业务订报 13.EO-SOP-16 办理宾客来店参观手续 14.EO-SOP-17 接待参观 15.EO-SOP-18 制定酒店工作计划 16.EO-SOP-19 总结年度工作程序 17.EO-SOP-20 基本决策程序 18.EO-SOP-21 设施设备添置、更新、和装修改造编制程序 19.EO-SOP-22 VIP接待程序 20.EO-SOP-23 总经理办公会程序 21.EO-SOP-24 内部文件传阅程序 22.EO-SOP-25 外部文件传阅程序 23.EO-SOP-26 公文制定程序

24.文件资料的归档处理程序 25.EO-SOP-28 保密文件的处理程序 26.EO-SOP-29 保密文件的查询、借阅程序 27.EO-SOP-30 信件处理程序 28.EO-SOP-31 《宾客意见书》处理程序 29.EO-SOP-33 会客、访客的程序 30.EO-SOP-34 内部用车审批程序 31.EO-SOP-35 车辆油料填加和审批程序 32.EO-SOP-36 车辆维护程序 33.EO-SOP-37 出差审批程序 34. EO-FORM-08 文件收发登记表 35. EO-FORM-09 车辆行使及油耗登记表 36. EO-FORM-10 宿舍申请表 37. EO-FORM-11 办公用品领用登记表 38. EO-FORM-12 发文稿纸 39. EO-FORM-13 公司文件稿纸 40. EO-FORM-14 宾客到店参观申请表 41. EO-FORM-15 文件资料调阅登记表 42. HR-SOP-01 员工招聘程序 43. HR-SOP-02 员工入职办理程序 44. HR-SOP-03 员工转正考核程序 45. HR-SOP-04 员工晋升、调动办理程序 46. HR-SOP-05 员工离职办理程序 47. HR-SOP-06 优秀员工评选程序 48. HR-SOP-07 员工投诉及建议处理程序

(完整版)药物临床试验制定SOP的标准操作规程

编号:HX-DS-001-2016/01 机密药物临床试验制定SOP的标准操作规程 版本号:2012/01 页数:4页(包括封面) 颁布日期:2010-12-01 起效日期:2016-12-01 起草人: 2016 年 11月 16 日 审核人: 2016 年 11 月 18 日 批准人:李梅华 2016 年 11 月 19 日 版本更新记录 版本号起效日期失效日期制(修)订理由简报2016/01 2016-12-01 原始版 审查记录 审查日期签名审查日期签名 1 5 2 6 3 7 4 8

昆明市第一人民医院药物临床试验机构文件类别:设计规范文件编号:HX-DS-001-2012/01 版次:2012/01 文件名称:药物临床试验方案设计规范页码:第1页共6页 1目的:为了规范呼吸专业组药物临床试验方案的设计,按照药物管理法、药物注 册管理办法、GCP及其相关规定的要求,特制订本规程。 2范围:本规程适用于呼吸专业组各类临床试验方案设计。 3职责:呼吸专业组研究人员对本规程实施负责。 4修订(制订)理由:原始版。 5依据:《GCP》。 6定义: 7程序内容: 制定SOP的SOP 目的:确保各项药物临床试验过程规范,数据真实,结果可靠,工作畅通,效率提高,顺利运转。 定义:标准操作规程(Standard Operating Procedure,SOP)为有效地实施和完成药物临床试验中的每项工作所拟定的标准和详细的书面规程。 范围:适用于所有药物临床试验。 内容:标准操作规程应符合我国GCP、相关法规和药物研究技术指导原则的要求,符合国际通用准则。内容应简明扼要、可操作性强,即“写所做 的,做所写的”。文词应规范,避免差错。SOP应格式统一,符合逻辑、内容编排与实际操作一致。 一、 SOP的起草 1. SOP编写小组首先对所有SOP进行设计和统一编码,以便保证所有SOP 按统一格式制定和保证SOP保存的完整性; 2. SOP编写小组确定SOP文件系统框架,定出所有SOP条目,并分派至相关部门组织编写; 3. 相关工作人员拟订的标准操作规程,其内容必须根据现行的GCP标准,格式应符合SOP编写小组制定的统一格式和编码要求。 二、 SOP的审核和批准 1. SOP起草后,交相关主管部门主管审核,再由编写小组对样稿进行审 阅、讨论、广泛征求意见,以保证其生效后的可行性。 2. 审核的要点: (1)是否与现行的GCP标准符合;

sop 企业标准操作手册

Hazard Analysis Critical Control Point Standard Operating Procedures Manual Clayton County School Nutrition Program 218 Stockbridge Road Jonesboro, Georgia 30236 678-479-0171 Implemented June 30, 2006as per Public Law 108-265, Section 9(h) of the Richard B. Russell National School Lunch Act

Hazard Analysis Critical Control Point HACCP Standard Operating Procedure Section 111 of the 2004 Child Nutrition and WIC (Women, Infants and Children) Reauthorization Act (Public Law 108-265) amended section 9(h) of the Richard B. Russell National School Lunch Act, included a new requirement for School Food Authorities (SFAs) to implement a documented School Food Safety Management System that includes HACCP Standard Operating Procedures (SOPs) based on the process approach to core Hazard Analysis and Critical Control Point (HACCP) principles. The Act mandates that local SFAs “implement the food safety program during the 2005-2006 school year.” HACCP is a systematic approach to construct a food safety program designed to reduce the risk of foodborne hazards by focusing on each step of the food preparation process---from receiving at the back dock to service to the students and other customers. Serving safe food is a serious and critical responsibility for our nutrition and food service professionals and is a key aspect of a healthy school environment. Keeping foods safe is also a vital part of healthy eating and is a recommendation of the 2005 Dietary Guidelines for Americans. When properly implemented, HACCP-based food safety programs will help ensure the safety of the school meals served to children and other customers in the Clayton County Public Schools.

人员培训标准操作规程SOP

人员培训标准操作规程SOP 一、目的;建立人员培训标准操作规程,确保培训规范的执行,提高全体员工素质。 二、适用范围:适用于全体员工的培训管理。 三、责任者:综合管理部。 四、管理制度: 1培训的基本原则: 1.1各级管理人员,生产、检验以及与生产活动有关的维修、纯洁、仓储、服务等人员,均应按《保健食品优良生产规范》(以下简称《规范》)的原则和各自的职责要求接受培训教育。 1.2培训教育方案应根据例外培训对象的要求分别制订。教材要深入浅出,注重普及与提高,理论与实践相结合。 1.3培训教育工作要制度化、规范化。个人培训记录要归档保存,培训效果要定期考核、评比。 1.4培训教育部门在编制企业教育规划及计划时,应将《规范》培训教育纳入计划,配备一定的任教人员,且任教人员的知识应不断提高更新,提高培训质量。 2培训的基本内容:根据培训的对象确定培训教育的内容,制定教育方案及培训教育达到的目的和要求。培训教育的基本内容包括有关法规、规定、制度的培训,包括《保健食品优良生产规范》、企业规章制度、工艺规程及岗位操作法等。 3培训的对象:培训对象是公司负责人、质量、生产制造等部门的负责人和从事生产、质量、销售、设备等部门的技术人员和管理人员及生产操作工人。 4培训的目的与要求: 4.1通过培训使全体员工意识到保健品的生产、经营等各个方面都已进入法制化的阶段。

4.2保健品是分外商品,保健品质量关系着人的康健,全体员工要确立质量第一的原则。 4.3使各级负责人具有相应的管理知识,懂得实施《规范》的意义和内容,掌握实施《规范》的有关知识、方法和评价的基本原则。 4.4使全体员工掌握企业的规章制度。 4.5技术、管理人员进行专业知识和管理知识的培训,使其在各自的岗位上,认真实施《规范》所规定的本岗位职责及活动内容。 4.6检验及操作人员进行全面的《规范》学习及保健品检验专业知识的培训和本岗位的操作规程、工艺流程、岗位责任制的学习,使其了解本岗位的质量责任。 4.7对全体员工进行纯洁卫生教育,使其养成优良的卫生习惯。 4.8对从事洁净区净化设施管理人员、设备维修保养人员进行《规范》知识、技能和方法的培训,使其明确本岗位的质量责任。 4.9对从事生产的各类人员进行符合本岗位要求的专业技能、操作方法与本岗位有关《规范》知识的培训,明确本岗位的质量责任。 5培训的方式 5.1公司派遣有关人员参加厂外的各类学习班、培训班和研讨班,使他们成为公司的培训业务力量。 5.2公司内脱产、半脱产及现场培训方式。 5.3采用三级培训—公司集中培训、部门培训、班组培训。 5.4组织有关人员到已通过GMP认证的保健品厂参观、学习、实习等多种方式。 6培训考核制度

制药公司文件管理操作规程SOP

制药公司文件管理操作规 程S O P Prepared on 22 November 2020

文件管理SOP 文件控制: 变更记载: 文件管理SOP 1目的:建立文件的设计、起草、审核、批准、替换或撤销、复制、分发、培训、执行、归档、变更、保存和销毁操作程序。 2适用范围 本标准适用于文件系统整个生命周期的控制。 3职责 文件编制者:依照该程序有关规定设计、起草制订文件。 各级生产质量管理人员:执行该程序的有关规定。

QA质量管理员:按该程序的有关规定进行归档、复制、保存、借阅、回收和销毁文件。 质量部QA:监督检查本程序的执行情况。 4内容 4.1文件的设计 文件设计时,文件的内容应当与药品生产许可、药品注册等相关要求一致,并有助于追溯每批产品的历史情况。 4.2文件的起草 4.2.1文件起草的时间要求 生产开工前、新产品投产前、新设备安装前;引进新处方或新方法前;处方或方法有重大变更时;验证前和验证后;组织机构职能变动时;文件编制质量改进时;使用中发现问题时;接受GMP检查认证或质量审计后;文件的定期复审时;有关法律、法规修订后(如中国药典、药品生产质量管理规范等) 4.2.2文件起草的基本要求 4.2.2.1文件应当标明题目、种类、目的以及文件编号和版本。 4.2.2.2文件的标题应能清楚地说明文件的性质。 4.2.3文件使用的语言确切、清晰、易懂、不能模棱两可。填写内容时应有足够的空格。文件的起草、修订、审核、批准的责任应明确,有责任人签名并注明日期。文件的起草: 4.2.3.1起草:由文件主要使用部门起草,以保证内容的全面性和准确性。并由起草人根据实际使用需要或会稿确定文件分发部门及分发份数。 4.2.3.2起草人向质量部QA质量管理员申请文件编号。 4.2.3.3文件格式及内容要求 4.2.3.3.1标准类文件格式和内容要求 ●标准类文件正常格式和内容要求 ●页眉:公司名称、文件名称、文件编号。 ●标题:文件的名称。 ●首页:起草人、审核人、批准人签名和日期,拷贝号,制定(变更)原因及目的,分发 部门及份数。

操作规程(SOP)

ABO血型鉴定(正定型法)标准操作规程 1.目的规ABO鉴定实验,确保ABO血型鉴定结果的准确。 2.适用围发血室,血型血清学实验室。 3.职责具有初级以上职称(检验),在血型鉴定和交叉配血工作岗位的工作人员有权执行本规程。出现血型鉴定结果本人无法判定,不能发出实验结果时,应当向上一级职称的检验人员或直接向本部门负责人报告并寻求技术上指导和帮助。 4.监督交叉配血试验审核者及实验室负责人监督工作人员是否遵从此项规程。 5.原理根据IgM类特异性血型抗体与红细胞上特异性抗原结合能够出现凝集反应的原理,用已知IgM类特异性标准抗血清与被检红细胞在盐水介质中反应,若出现凝集现象,表明被检红细胞膜上有与血型抗体相对应的抗原,从而判断和鉴定被检者的血型。 6.材料 (1)抗A、抗B血型定型试剂(单克隆抗体) 规格:10ml/支 保存:于2-8℃避光保存,有效期使用 效价:≥1﹕128 包装:抗A抗B各一支/盒塑料瓶

有效期:自成品鉴定合格之日起1年。 批准文号:国药准字S1******* 厂商:博德生物技术有限责任公司 (2)受检者3%-5%红细胞盐水悬液。 (3)经过校准的台式离心机。 7.操作 5%被检红细胞生理盐水悬液制备;抗凝血离心或红细胞自然沉降后取下层红细胞2滴于小试管中,加入生理盐水2ml用尖滴管将红细胞与生理盐水充分混匀,2500r/min离心3min后弃去上清液,重复洗涤3次后,自管底吸取1滴压迹红细胞加入19滴生理盐水中,此即为5%的红细胞生理盐水悬液。 (1)平板法(玻片法) 标记玻片或白瓷板取洁净的玻片或白瓷板1块,用蜡笔划出小格, 做好编号标记抗A、抗B。 加标准抗血清在玻片或白瓷板已标记的区域分别滴加抗A、抗B 标准抗血清1滴。 加被检红细胞悬液在滴加抗A、抗B标准抗血清的小格中分别加 被检者5%的红细胞生理盐水悬液各1滴,不断 摇动玻片或白瓷板,使血清与红细胞充分混匀, 室温放置15-30min。 观察结果先轻轻摇动玻片,肉眼观察有无颗粒状凝集及凝集程度,再用低倍镜观察,判定阴阳性及阳性程度。

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