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QUALITY AUDITS

iCAN GMP

Did you know there are various business, legal, quality, and regulatory risks from nonconforming raw materials, in-process products, finished products, and corresponding internal and external supply chain services?

For example:

  • Loss of resources;

  • Loss of sales;

  • Loss of face;

  • Disgruntled and/or loss of employees (including whistleblowers);

  • Loss of suppliers and customers;

  • Enforcement actions (such as from warning letters to product seizures and prosecutions);

  • Decreased competitive advantages;

  • Lawsuits and other liabilities; and

  • Increased corrective action costs (including costs associated with recalls and product and/or process changes and the hiring of consultants).

Did you know…

 

  • Audits prevent and/or lessen various business, legal, quality, and regulatory risks?

  •  An audit is a non-biased, planned, objective, and independent confirmation, evaluation, investigation, and/or verification of a person, organization, system, process, enterprise, project or product against predetermined governmental, industrial, procedural, customer, and/or other internal and external requirements and standards?

  •  Audits are not a quick look of a company’s operations?

  •  Audits are preventive and not detective?

  •  Audits are planned, organized, coordinated, systematic, independent, and documented?

  •  Audits are carried out for the benefit of the company’s management (not the auditor)?

  •  A single audit will not find all noncompliant issues or potential problems?

  •  Industry audits are not inspections (non-governmental)?

  1. Industry audits are snapshots in time and vary by purpose and scope

    • An audit is a quality assurance tool to prevent quality system errors or defects against internal and external requirements and standards;

    • Audit findings are not the fault of individuals, but of an ineffective quality system caused by poor planning by top management;

    • If individuals purposely and knowingly cause nonconformances after they have been trained and know these actions are in violation of internal and external requirements, this is a Human Resources issue (not a quality system issue) 

  2. Industry inspections are consistent in time, purpose, and scope

    • An inspection (non-governmental) is a quality control tool that is part of the manufacturing or service approval process to detect errors or defects against predetermined specifications before a product is approved for release or distribution or a service is performed.

THERE ARE VARIOUS TYPES OF AUDITS?

A quality audit is objective assessment, performed at defined intervals and at sufficient frequency, of a company’s quality system to operate against a given criteria?

 

  • There are two (2) main categories of quality audits?

    1. Internal Audits; and

      • Performed within an organization by qualified internal auditors and/or external contractors and consultants to measure its strengths and weaknesses against its own procedures or methods and/or against external requirements and standards

    2. External Audits

      • Second Party Audits

        • Performed on a supplier by a customer or by a contracted organization on behalf of a customer

      • Third Party Audits

        • Performed by an external audit organization (government, agent of the government, and/or external contractors and consultants) independent of the customer- supplier relationship and is free of any conflict of interest

There are three (3) types of quality audits?

  • 1st party audits- internal audits of a company’s operations

  • 2nd party audits- external supplier audits to select, assess, and/or control vendor and contractor operations associated with your products and services

  • 3rd party audits- external independent audits (such as performed by governmental agencies and/or their agents) or independent mock/ compliance/ for-cause audits performed under contract by qualified consultants

QUALITY AUDITS CAN BE PERFORMED ON SITE AND/OR OFF SITE (SUCH AS THROUGH DESK-AUDITS)?

What quality audits measure?

  • Adequacy of the documentation and data;

  • Adherence to documented and undocumented procedures;

  • Implementation and maintenance of procedures;

  • Effectiveness of the procedures as implemented to accomplish intended objectives;

  • Conformity and compliance of procedures, documentation, and data against internal and external requirements; and

  • Assurance that the company is/ is not in a state of control (at lease since the prior audit)

The purpose of quality audits?

  • To provide input for management decisions so that problems and costs can be prevented or rectified;

  • To keep management informed of actual or potential risks;

  • To identify areas of opportunity for continuous improvement;

  • To assess personnel training effectiveness and equipment capability;

  • To provide visible management support of the quality, environment, safety, and financial programs;

  • To ensure ongoing compliance and conformity to regulations and standards;

  • To determine system and process effectiveness; and

  • To identify system and process inefficiencies.

Quality audits vary depending upon the audit scope?

  1. Routine audits

    • Quality system audits

    • Departmental or Functional Audits

  2. Performance audits

  3. Compliance audits

  4. Desk audits

  5. Follow-up audits

There are two (2) types of approaches to quality audits?

  1. Vertical Auditing:

    • In depth auditing at a particular function or department

    • Monitor the use of all relevant procedures that support the function or activity

    • Typically internal audits

  2. Horizontal Auditing

    • Auditing that follows a process from the start to the end

    • Access the use of all relevant procedures that support the process itself and are likely to span across many different functions or departments

    • Typically external audits, including assessments that lead to certification

  • There are mandatory 1st and 2nd party quality audits are required for manufacturers of certain FDA regulated products (such as medical devices and combination products per FDA QSR requirements under 21 CFR parts 4.4 and 820.22)?

ARE YOU AND YOUR COMPANY STAFF EQUIPPED TO PERFORM QUALITY AUDITS?

If not, iCAN GMP has qualified auditors (including ex-FDA certified investigators) who are able to provide all types of 1st, 2nd, and 3rd party audits (including onsite audits as well as off-site desk audits).

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