Quality Procedure

‍Quality Procedure (often simply referred to as a "Procedure") are a set of instructions that detail the necessary steps and activities to be followed in the execution of specific processes within a Quality Management System (QMS).

A Quality Procedure is a controlled document that outlines who performs what steps, how, when, and where within a QMS process. These documents ensure that complex activities are performed consistently across the organization to meet quality standards.

Quality Procedures form a crucial part of the QMS documentation hierarchy, translating high-level policies into functional instructions for personnel.

Role in QMS Documentation Hierarchy

Procedures reside in the middle tier of the traditional QMS documentation hierarchy, bridging the gap between high-level policy and specific action:

1. Quality Policy (Top Level: Overall intentions).
2. Quality Manual (Overview: QMS structure and scope).
3. Procedures (Middle Level: Documented instructions for processes).
4. Work Instructions (Detailed steps for activities).
5. Records and Forms (Bottom Level: Evidence of compliance).

The goal of procedures is to establish a clear framework of operations and allow for consistency of processes across the organization.

Regulatory Requirements for Procedures

In regulated environments like medical device manufacturing, procedures are mandatory for virtually every core quality activity:

FDA QSR/QMSR: Under the former Quality System Regulation (QSR) (21 CFR Part 820), manufacturers were required to establish and maintain documented procedures for nearly all required activities, including Management Review, Quality Audits, Production and Process Controls, Corrective and Preventive Action (CAPA) [78(a)], and Complaint Handling [84(a)]. The QMSR continues this requirement by incorporating ISO 13485:2016.

Production and Process Controls: Procedures are necessary to monitor and control process parameters for validated processes [72(b)] and to control production processes to ensure that a device conforms to specifications [65(a)]. Where process control procedures are needed, they must include documented instructions, standard operating procedures (SOPs), and methods that define and control the manner of production [66(1)].

HCT/P (Tissue) Requirements: Establishments manufacturing human cells, tissues, and cellular and tissue-based products (HCT/P) must establish and maintain procedures for all steps they perform in testing, screening, and processing, designed to ensure compliance with requirements and prevent communicable disease transmission risks [202(a), 208(a)].

Content and Structure of Quality Procedures

Quality Procedures are formalized instructions that define the steps and activities for processes within the QMS. Procedures can use different formats, such as narrative text, structured tables, flow charts, or descriptive imagery, or a combination thereof.

A quality procedure should typically include the following elements:

• Title: For identification.
• Purpose: Describing the rationale behind the procedure.
• Scope: Explaining the aspects covered and excluded by the procedure.
• Responsibilities and Authorities: Defining who is included in any part of the procedure.
• Description of Activities: The main section that describes what should be done, by whom, and how, when, and where. This section should also explain the inputs and the outputs of the activities, including required resources.
• Document Control: Identification of changes, date of review, approval, and version information.
• Definitions and Lists of Records: Defining terms and listing the resulting records that stem from the activities.
• Appendices: May be included if needed.

Relationship with Other Documentation

Work Instructions: Quality Procedures can either contain Work Instructions or reference them separately. Work Instructions generally cover the same elements as procedures but include more details focused on the sequencing of steps, tools, and required accuracy. Training of personnel may decrease the need for highly detailed work instructions.

Continuous Improvement: The CAPA process requires implementing and recording changes to methods and procedures needed to correct and prevent identified quality problems [79(5)].

Non-Mandatory Status in ISO 9001:2015: While the previous version of ISO 9001 required six specific procedures, ISO 9001:2015 has no mandatory procedures. However, organizations usually create them to ensure that processes occur as planned and to avoid nonconformity within the QMS scope.

Analogy for Understanding a Quality Procedure

If the Quality Policy is the organization's declaration ("We aim to deliver every package to the customer's door in perfect condition"), and the Quality Manual is the outline of the shipping department, the Quality Procedure is the step-by-step instruction manual for operating the forklift.

It specifies:

• Scope: This procedure applies to moving all pallets weighing over 500 lbs.
• Responsibility: Only personnel with Forklift Certification (Training Record) are authorized.
• Activity: (Step 1) Check equipment calibration records. (Step 2) Lift the pallet using the prescribed method (Work Instruction). (Step 3) Document the transfer time on the Pallet Log (Record/Form).

This ensures every forklift operator handles packages consistently and safely, regardless of who is performing the task.

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