FDA requirement: 21 CFR 820 and ISO 9001:2008

Compliance ISO 9001:2008 to requirement FDA: 21 CFR 820

21 CFR 820: Brief Description: ISO 9001:2008 clauses:
§ 820.1 – Scope.
§ 820.3 – Definitions.
§ 820.5 – Quality system.
General Provisions Scope: 1, 2, 3                                               4.1-General Requirement
§ 820.20 – Management responsibility.
§ 820.22 – Quality audit.
§ 820.25 – Personnel.
Quality System Requirements clause 5: Management Responsibilityclause 8.2.2: Internal Audit

clause 6.2 Human Resources

§ 820.30 – Design controls Design Controls clause  7.3 Design and Development
§ 820.40 – Document controls Document controls clause 4.2 Documentation Requirements
§ 820.50 – Purchasing controls. Purchasing controls. clause 7.4 Purchasing
§ 820.60 Identification.
§ 820.65 – Traceability.
Identification and Traceability clause 7.5.3 Identification and Traceability
§ 820.70 – Production and process controls.
§ 820.72 – Inspection, measuring, and test equipment.
§ 820.75 – Process validation.
Production and Process Controls clause 7.5 Production and service provision                                                  clause 7.6 Control of monitoring and measuring equipment
 § 820.80 – Receiving, in-process, and finished device acceptance.
§ 820.86 – Acceptance status.
Acceptance Activities clause 7.4.3 Verification of purchased product  clause 7.1 Product realization
§ 820.90 – Nonconforming product. Nonconforming product. clause 8.3 Control of noncoforming product
§ 820.100 – Corrective and preventive action. Corrective and preventive action. cluase 8.5.2 Corrective Actionclause 8.5.3 Preventive action
§ 820.120 – Device labeling.
§ 820.130 – Device packaging.
Labeling and Packaging Control

§ 820.140 – Handling.
§ 820.150 Storage.           § 820.160-Distribution

Handling, Storage, Distribution, and Installation 7.5.5 Preservation of product
§ 820.180 – General requirements.
§ 820.186 – Quality system record.
§ 820.198 – Complaint files.
Records clause 4.3 Control of records
§ 820.250 – Statistical techniques. Statistical Techniques clause 8.4 Analysis of data

Role of Quality Manager

  1. Quality Standards.  Documents and records are used all throughout the company.  Nobody should know more about quality, compliance and processes than the Quality Manager.  Your experience with Good Manufacturing Practices (GMP), ISO standards (i.e. ISO 9001), or 21 CFR 820 within a regulated industry are important to managing and controlling documents and records.
  2. Quality Project Management.  A Quality Manager is also a project manager managing corrective action, process improvement, and auditing projects.  One must have strong self-motivation, the ability to work independently, and within a team environment with strong follow up, organization and prioritization skills and excellent attention to detail helps too.  Perhaps most important of all is understanding the financial – risk-reward – trade-offs in good project management.
  3. Business Process Documentation.  A Quality Manager must be able to understand, comply, and improve established company policies and procedures.  Developing standard work, policies, procedures, job aids, and business process communications are a part of the job.  A Quality Manager is also a technical writer.  Familiarity with policy and procedure writing will help you to succeed.  Technical writing conveys technical information using active voice construction, instructional design, and desktop publishing methods to transfer information into understandable and useful information.
  4. Document Control.  As the Quality Manager, your Knowledge of the Quality documentation process, Document Control practices, and managing documents, records, forms, and work instructions is vital to maintaining your company’s compliance program.  A Quality Manager may be the Document Control Manager responsible for organizing documents into an easy to use and fast retrieval system.  Users need their policies and procedures to conform to requirements.  If they cannot find them, then they cannot follow them… Document control is an important priority.
  5. quality managerQuality Communications.  It might go without saying but explaining business process compliance to others is what a Quality Manager has to do.  Being able to understand a variety of instructions furnished in written, oral, diagram, or schedule form helps others to follow and conform to the established best practice.  Communicating compliance and conformance is done using software such as Microsoft Word and Excel, training using PowerPoint, process mapping using Visio, Statistical Process Control (SPC) using statistics, as well as document revision control software for policies and procedures management.
  6. People Management.  A Quality Manager should not be afraid of asking questions, collecting business process information, and working with others in a positive and collaborative manner.  Business processes include sensitive accounting and financial processes too.  So, you must be comfortable speaking effectively and communicating directly with all levels of personnel.
  7. Quality Auditing.  A Quality Manager performs some of the quality audits.  Supply chain audits, process audits, and may even lead ISO audits an act as a Lead Auditor managing teams of auditors.  Clearly understanding the compliance requirements, collecting objective evidence, and writing up audit reports ensure the quality management system is operating effectively.
  8. Problem Solving.  The Quality Manager solves problems, typically in situations where general standardization should exist, but may not be operating effectively.  Using process mapping techniques, lean, or Six Sigma process improvement methodology is essential to reducing waste and being effective in the Quality role.   A delicate balance exists between resolving problems yourself and identifying those situations that require management intervention for a solution.  Good political judgment is required where quality and compliance are concerned.
  9. Team Player.  The Quality Manager is involved in teams and meetings at every level of the organization.  Management reviews, material reviews, supplier reviews, corrective action reviews, process improvement teams, audits, customer visits and strategy discussions.  A good Quality Manager is involved with many areas of the company.
  10. Quality “Go To” Guy.  The Quality Manager is the person that everybody goes to to get answers about quality.  Product specifications, supplier requirements, testing, inspections, part verification, equipment calibration, corrective actions, non-conformances, workers compensation, benchmarking, voice of the customer, and on and on.  The buck stops here at Quality.

 

Source: www.bizmanualz.com

How to Select Quality Vendor

How to Select Quality Vendor

contact:  kris@themanagementsystems.comchoose-person

The vendor selection process can be a very complicated and emotional undertaking if you don’t know how to approach it from the very start. Here are five steps to help you select the right vendor for your business. This guide will show you how to analyze your business requirements, search for prospective vendors, lead the team in selecting the winning vendor and provide you with insight on contract negotiations and avoiding negotiation mistakes.

1. Analyze the Business Requirements

Before you begin to gather data or perform interviews, assemble a team of people who have a vested interest in this particular vendor selection process. The first task that the vendor selection team needs accomplish is to define, in writing, the product, material or service that you are searching for a vendor. Next define the technical and business requirements. Also, define the vendor requirements. Finally, publish your document to the areas relevant to this vendor selection process and seek their input. Have the team analyze the comments and create a final document. In summary:

-Assemble an Evaluation Team

-Define the Product, Material or Service

-Define the Technical and Business Requirements

-Define the Vendor Requirements

-Publish a Requirements Document for Approval

2. Vendor Search

Now that you have agreement on the business and vendor requirements, the team now must start to search for possible vendors that will be able to deliver the material, product or service. The larger the scope of the vendor selection process the more vendors you should put on the table. Of course, not all vendors will meet your minimum requirements and the team will have to decide which vendors you will seek more information from. Next write a Request for Information (RFI) and send it to the selected vendors. Finally, evaluate their responses and select a small number of vendors that will make the “Short List” and move on to the next round. In summary:

-Compile a List of Possible Vendors

-Select Vendors to Request More Information From

-Write a Request for Information (RFI)

-Evaluate Responses and Create a “Short List” of Vendors

3. Request for Proposal (RFP) and Request for Quotation (RFQ)

The business requirements are defined and you have a short list of vendors that you want to evaluate. It is now time to write a Request for Proposal or Request for Quotation. Which ever format you decide, your RFP or RFQ should contain the following sections:

-Submission Details

-Introduction and Executive Summary

-Business Overview & Background

-Detailed Specifications

-Assumptions & Constraints

-Terms and Conditions

-Selection Criteria

4. Proposal Evaluation and Vendor Selection

The main objective of this phase is to minimize human emotion and political positioning in order to arrive at a decision that is in the best interest of the company. Be thorough in your investigation, seek input from all stakeholders and use the following methodology to lead the team to a unified vendor selection decision:

Preliminary Review of All Vendor Proposals

Record Business Requirements and Vendor Requirements

Assign Importance Value for Each Requirement

Assign a Performance Value for Each Requirement

Calculate a Total Performance Score

Select a the Winning Vendor

5. Contract Negotiation Strategies

The final stage in the vendor selection process is developing a contract negotiation strategy. Remember, you want to “partner” with your vendor and not “take them to the cleaners.” Review your objectives for your contract negotiation and plan for the negotiations be covering the following items:

-List Rank Your Priorities Along With Alternatives

-Know the Difference Between What You Need and What You Want

-Know Your Bottom Line So You Know When to Walk Away

-Define Any Time Constraints and Benchmarks

-Assess Potential Liabilities and Risks

-Confidentiality, non-compete, dispute resolution, changes in requirements

-Do the Same for Your Vendor (i.e. Walk a Mile in Their Shoes)

6. Contract Negotiation Mistakes

The smallest mistake can kill an otherwise productive contract negotiation process. Avoid these ten contract negotiation mistakes and avoid jeopardizing an otherwise productive contract negotiation process.

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