QS0002-02: Controlled Document Procedures

Question 1

QS0002-01: Controlled Document Procedures

What is a Controlled document?

Answer 1

A controlled document is a document that must undergo formal review, approval, controlled distribution, modification, and managed storage and access.

Question 2

QS0002-01: Controlled Document Procedures

Describe a policy statement.

Answer 2

Policies are high-level management statements, instructions, or business rules that enable individuals to make present and future decisions. Policies are mandatory. Special approval is required when anyone wishes to take a course of action that is not in compliance with the policy. For example, Policy: You must use a user ID and Password when accountability is required.

Question 3

QS0002-01: Controlled Document Procedures

Describe a standard statement in policy.

Answer 3

Standards are typically collections of system-specific or procedural-specific requirements and are mandatory.

Question 4

What is a procedure?

Answer 4

Procedures are specific operational steps or manual methods that support a policy or a standard.

Question 5

QS0002-01: Controlled Document Procedures

What are four types of Controlled documents defined within the “LLX SOPs” space in Confluence?

Answer 5

1. Information System Standards
2. Quality System Standards
3. Work Instructions
4. Forms

Question 6

QS0002-01: Controlled Document Procedures

What are the four statuses of the Controlled documents?

Answer 6

1. Draft
2. Issued
3. Superseded
4. Retired

Question 7

QS0002-01: Controlled Document Procedures

Where are the Quality Documents managed and approved?

Answer 7

Jira project “Quality Documents” manages and documents the approval process.