文件与记录控制培训
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Documents and Records
1
Learning Objectives
At the conclusion of this session, you will be able to:
▪ explain the difference between documents and
records;
purpose
serve as the framework for the quality system should always be specified in the quality
manual
Documents and Records - Module 16
9
Processes - The “HOW IT HAPPENS”
of the laboratory
Documents and Records - Module 16
Leabharlann Baidu
7
Policies
Procedures
Laboratory Documents
Processes
Documents and Records - Module 16
8
Policies - The “WHAT TO DO”
▪ describe the hierarchy of documents and the
role of each level;
▪ outline the contents of a quality manual; ▪ outline the content that should be included in a
standard operating procedure;
▪ explain the important steps, or elements, of a
laboratory document management system;
▪ describe methods and tools to properly store
Documents and Records - Module 16
5
Documents and Records—How do they differ?
Documents
communicate
information via policies, processes, and procedures
need updating
“A written statement of overall intentions and directions defined by those in the organization and endorsed by management.” (CLSI HS1-A3)
Policies:
tell “what to do” in a broad and general way include the organizational mission, goals, and
Facilities &
Safety
Documents and Records - Module 16
4
Why do laboratories need to manage documents and records?
To find information whenever it is needed!
testing algorithm
safety manual
client test results
standard operation procedures (SOPs) for an approved HIV rapid test
manufacturer test kit inserts
summary of findings from on-site evaluation visit
report of corrective actions
temperature log (blank form)
quality control record (blank form)
daily maintenance log (completed)
stock cards and stock book (completed)
EQA specimen transfer log (completed)
Documents and Records - Module 16
3
The Quality Management System
Organization
Records
capture information
on worksheets, forms, labels, and charts
permanent, do not
change
RECORDS
Documents and Records - Module 16
6
Information is the major product
Personnel
Equipment
Purchasing &
Inventory
Process Control
Information Management
Documents &
Records
Occurrence Management
Assessment
Process Improvement
Customer Service
A “set of interrelated or interacting activities that transform inputs into outputs.” (ISO 9000 4.3.1) Processes: describe the steps involved to carry out quality policies easily represented in flow charts involve a series of steps, usually occurring over a period of time
documents and records.
Documents and Records - Module 16
2
Scenario
You have found all these papers lying on a desk. Which of these are documents and which are records?
1
Learning Objectives
At the conclusion of this session, you will be able to:
▪ explain the difference between documents and
records;
purpose
serve as the framework for the quality system should always be specified in the quality
manual
Documents and Records - Module 16
9
Processes - The “HOW IT HAPPENS”
of the laboratory
Documents and Records - Module 16
Leabharlann Baidu
7
Policies
Procedures
Laboratory Documents
Processes
Documents and Records - Module 16
8
Policies - The “WHAT TO DO”
▪ describe the hierarchy of documents and the
role of each level;
▪ outline the contents of a quality manual; ▪ outline the content that should be included in a
standard operating procedure;
▪ explain the important steps, or elements, of a
laboratory document management system;
▪ describe methods and tools to properly store
Documents and Records - Module 16
5
Documents and Records—How do they differ?
Documents
communicate
information via policies, processes, and procedures
need updating
“A written statement of overall intentions and directions defined by those in the organization and endorsed by management.” (CLSI HS1-A3)
Policies:
tell “what to do” in a broad and general way include the organizational mission, goals, and
Facilities &
Safety
Documents and Records - Module 16
4
Why do laboratories need to manage documents and records?
To find information whenever it is needed!
testing algorithm
safety manual
client test results
standard operation procedures (SOPs) for an approved HIV rapid test
manufacturer test kit inserts
summary of findings from on-site evaluation visit
report of corrective actions
temperature log (blank form)
quality control record (blank form)
daily maintenance log (completed)
stock cards and stock book (completed)
EQA specimen transfer log (completed)
Documents and Records - Module 16
3
The Quality Management System
Organization
Records
capture information
on worksheets, forms, labels, and charts
permanent, do not
change
RECORDS
Documents and Records - Module 16
6
Information is the major product
Personnel
Equipment
Purchasing &
Inventory
Process Control
Information Management
Documents &
Records
Occurrence Management
Assessment
Process Improvement
Customer Service
A “set of interrelated or interacting activities that transform inputs into outputs.” (ISO 9000 4.3.1) Processes: describe the steps involved to carry out quality policies easily represented in flow charts involve a series of steps, usually occurring over a period of time
documents and records.
Documents and Records - Module 16
2
Scenario
You have found all these papers lying on a desk. Which of these are documents and which are records?