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;
? testing algorithm
? safety manual
? client test results
? standard operation procedures (SOPs) for an approved HIV rapid test
? manufacturer test kit inserts
Facilities &
Safety
Documents and Records - Module 16
4
Why do laboratories need to manage documents and records?
To find information whenever it is needed!
standard operating procedure;
?explain the important steps, or elements, of a
laboratory document management system;
?describe methods and tools to properly store
“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
puBaidu Nhomakorabeapose
?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”
? 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)
Personnel
Equipment
Purchasing &
Inventory
Process Control
Information Management
Documents &
Records
Occurrence Management
Assessment
Process Improvement
Customer Service
of the laboratory
Documents and Records - Module 16
7
Policies
Procedures
Laboratory Documents
Processes
Documents and Records - Module 16
8
Policies - The “WHAT TO DO”
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
? stock cards and stock book (completed)
? EQA specimen transfer log (completed)
Documents and Records - Module 16
3
The Quality Management System
Organization
?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
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
Documents and Records - Module 16
5
Documents and Records —How do they differ?
Documents
?communicate
information via policies, processes, and procedures
?need updating
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;
? testing algorithm
? safety manual
? client test results
? standard operation procedures (SOPs) for an approved HIV rapid test
? manufacturer test kit inserts
Facilities &
Safety
Documents and Records - Module 16
4
Why do laboratories need to manage documents and records?
To find information whenever it is needed!
standard operating procedure;
?explain the important steps, or elements, of a
laboratory document management system;
?describe methods and tools to properly store
“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
puBaidu Nhomakorabeapose
?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”
? 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)
Personnel
Equipment
Purchasing &
Inventory
Process Control
Information Management
Documents &
Records
Occurrence Management
Assessment
Process Improvement
Customer Service
of the laboratory
Documents and Records - Module 16
7
Policies
Procedures
Laboratory Documents
Processes
Documents and Records - Module 16
8
Policies - The “WHAT TO DO”
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
? stock cards and stock book (completed)
? EQA specimen transfer log (completed)
Documents and Records - Module 16
3
The Quality Management System
Organization
?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
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
Documents and Records - Module 16
5
Documents and Records —How do they differ?
Documents
?communicate
information via policies, processes, and procedures
?need updating
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?