STANDARD OPERATING PROCEDUREPage 1 of 7
Document Number: S-522 Version 1.xx
Subcontracting of Testing and Calibration

Standard Operating Procedure

Subcontracting of Testing and Calibration

This is an example of a Standard Operating Procedure. It is a proposal and starting point only. The type and extent of documentation depends on the process environment. The proposed documentation should be adapted accordingly and should be based on individual risk assessments. There is no guarantee that this document will pass a regulatory inspection.

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Superseded Document / N/A, new
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Effective Date / March 1, 2012
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Approver / I indicate that I have reviewed this SOP, and find it meets all applicable business requirements and that it reflects the procedure described. I approve it for use.
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Reviewer / I indicate that I have reviewed this SOP and find that it meets all applicable quality requirements and company standards. I approve it for use.
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1.PURPOSE

When a laboratory subcontracts work, either because of unforeseen reasons (e.g., workload, need for further expertise or temporary incapacity) or on a continuous basis (e.g., through permanent subcontracting), this work should be placed with a competent subcontractor. This SOP guides user firms through the assessment process.

2.SCOPE

Subcontracting testing and calibration of laboratories operating in FDA and equivalent international environments, and/or operating under ISO 17025 and equivalent quality systems.

3.GLOSSARY/DEFINITIONS

Item / Explanation
Work / Testing and/or calibration.

Note: For other definitions, see .

4.REFERENCE DOCUMENTS

N/A

5.RESPONSIBILITIES

5.1.Process Owner

5.1.1.Leads the subcontracting process.

5.1.2.Defines the test and calibration requirements and acceptance criteria.

5.1.3.Communicates the status to the client.

5.2.Quality Assurance

5.2.1.Assists the project owner on quality system related questions.

5.2.2.Leads the process to audit the subcontractor, if necessary.

5.3.Laboratory Management

5.3.1.Defines the need for subcontracting.

5.3.2.Defines a process owner for subcontracting.

5.3.3.Provides resources to assist the project owner on technical questions.

5.4.Laboratory Staff and Supervisors

5.4.1.Assist the project owner on technical questions.

5.4.2.Randomly review work done by the subcontractor for technical quality.

6.FREQUENCY OF USE

6.1.Before subcontracting work.

7.PROCEDURE

7.1.Subcontracting Initiation

7.1.1.The laboratory gets a request from the client to perform a specific work, e.g., specific type and number of tests.

7.1.2.The laboratory supervisor responsible decides that the work cannot be performed because of limited resources, either technical or personnel.

7.1.3.The laboratory supervisor determines a project leader for possible subcontracting.

7.1.4.The project leader describes the work to be subcontracted such that a decision can be made to go ahead and subcontract or reject the work.

The description includes:

  • Type and number of samples.
  • Technical requirements.
  • Rough return on investment.
  • Management makes a decision to subcontract the work based on business opportunity and resources.
  • The project leader informs the client about the proposal to subcontract the work.
  1. Identification of the Subcontractor
  2. The project leader makes a proposal for the selection of the subcontractor, preferably from a list of authorized subcontractors.
  3. If there is no authorized subcontractor for the work the proposal is based on the reputation of the subcontractor, anticipated technical competence and accreditation status, e.g., ISO 17025.
  4. The project leader calls a meeting with management and QA and makes a final decision on the priority list.
  5. If the candidate is not an authorized supplier, QA leads the process for assessment following the order of the priority list as defined in 7.2.3.

Assessment criteria are:

  • Implemented quality system.
  • Technical competence.
  • Financial competitiveness.

The company that first meets the assessment criteria will be selected as subcontractor.

7.2.5.The project leader informs affected parties within the company about the selection process, the justification and the final decision on the contractor.

7.3.Definition and Agreement of the Work

7.3.1.The project leader describes the work in detail, e.g.,

  • Responsibilities of the subcontractor.
  • Equipment.
  • Test procedures.
  • Quality control procedures.
  • Regulatory requirements.
  • Acceptance criteria.
  • Deliverables.
  • Suggested time schedule.
  • Price expectations.
  • The subcontractor evaluates and agrees or disagrees with the proposal.
  • If necessary, the project leader arranges for a meeting with the subcontractor representative to agree on open issues including pricing and timing.
  • The subcontractor confirms in writing that the company;
  • Clearly understands the requirements as described in 7.3.1 and agreed in 7.3.3.
  • Has the expertise and resources to perform the work in the time frame.
  • Conduct of Work
  • The project leader arranges for shipment of the test samples or calibration items.
  • The subcontractor performs the work and sends the results to the project leader.
  • The project leader compares the results and other deliverables with the description in 7.3.1.
  • The project leader summarizes the project, the findings and the recommendations to improve future projects, if necessary.
  • The project leader presents the results to the client.

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