Checklist Documents and records

Does the laboratory have a Master SOP that explains how to write SOPs?

 Activity

Does the Master SOP have different sections on how to write Analysis SOPs, Equipment SOPs and Procedure SOPs?

 Activity

Does the laboratory have an overview of the time each type of record should be archived?

 Activity

Does the laboratory have an overview of where each type of record should be archived?

 Activity

Are SOPs available at logical locations, at least:

  • Near the place where the procedures the SOPs describe are routinely performed
  • In the office areas
  • In the dedicated quality documents archive

 Activity

Are inconsistencies and errors found in documents recorded in a Document Revision Form?

 Activity

Do staff members know where to find the Document Revision Form?

 Activity

Do staff members know what the Document Revision Form is for and do they know how to use it?

 Activity

Is a Document Control Log available that shows all the quality documents of the laboratory with at least the following details:

  • The document code
  • The document title
  • The name of the author
  • The names of the reviewers
  • The name of the authorizer
  • The current version number
  • The date on which it was released for use
  • The date before which the document must be reviewed
  • Distribution list
  • Remarks
  • The title of the previous version
  • The name of the author of the previous version
  • The names of the reviewers of the previous version
  • The name of the authorizer of the previous version
  • The date on which the previous version was released for use
  • The date on which the previous version was replaced

 Activity

Is each quality document (SOP, quality manual chapter, Biosafety Manual chapter) supplied with a front page that contains the following information: [tick off]

  • Document code
  • The document title
  • The name of the author
  • The names of the reviewers
  • The name of the authorizer
  • The current version number
  • The date on which it was released for use
  • The date before the document must be reviewed
  • Distribution list
  • Description of changes compared to previous version

 Activity

Does the laboratory have a document control system that ensures that all its quality documents are reviewed, and, when necessary, revised on an annual (or, after maturation of the quality management system, biannual) basis?

 Activity

Are the Bench Aids used in the laboratory based on current versions of SOPs?

 Activity

Have all quality documents currently in use been reviewed by at least one reviewer?

 Activity

Are all the quality documents used in the laboratory authorized for release?

 Activity

Are all the quality documents used in the laboratory the current versions?

 Activity

Are copies of replaced quality documents in the quality documentation archive clearly marked as “replaced” with the date on which they were replaced?

 Activity

Are all the references in quality documents to other documents, locations and equipment correct?

 Activity

Does the laboratory have a dedicated archive in which it stores all its current and replaced quality documents for a period of five years?

 Activity

Are all the procedures related to the document control system standardized in an SOP?

 Activity

Is staff aware of what they have to do when they detect an error in a quality document?

Take a sample by asking several staff members.

 Activity

Are the Equipment SOPs complete, i.e. do they include the procedures that were developed in phase 2 such as calibration, preventive maintenance and corrective maintenance?

 Activity

LQSI tool version: 1.0

LQSI tool version: 1.0