First Key’s QMS is for the management and assurance of product quality. It provides a statement of Quality Policy, and details procedures and methods by which the policy is to be adhered to. It sets out quality goals and how they will be achieved and defines responsibilities for each manufacturing stage and product quality. It also defines actions of what is to be done at each quality-critical stage and lays out standard methods for handling quality issues (e.g. out of spec product)
Classic QMS starts with a strategic statement of the company’s quality policy and philosophy. It then outlines the specific procedures and instructions of who does what, when, where, and how. This includes instructions on how work is done, sampling plans, reporting format, specifications, recipes, corrective actions, and laboratory analytical methods. These are laid out in a Technical Manual. Naturally, the intent is to keep it simple but also effective.
Technical Manual Format:
- Introduction – contains a QMS rationale and definition.
- Quality Policy – a statement of management’s quality commitment as well as the policy and specific quantified quality goals.
- Organization – shows who is responsible for what in regards to quality, as well as individual responsibilities.
- Description of Process Unit Operations – contains specific focus on quality-critical operations and activities. This may include:
- Plant overview
- Raw material receiving and storage
- Yeast Management
- Maturation and Stabilization
- Packaging (Bottling, Canning, Kegging)
- Utilities and Maintenance
- Laboratory (Test equipment, methodology)
- Specifications – raw materials, in-process product, finished product.
- Sampling plans – for all raw materials used, and at critical points in the process.
- Analytical – microbiological, chemical, packaging, and sensory.
- Recording Systems
- Reporting Systems – Operator, Management. May also outline which statistical techniques are to be used.
- Non-conforming Products – details how to resolve out-of-spec issues.
- Education and Training – outlines prerequisite credentials of those responsible for quality.
- Post Audit – describes periodic system for assessing if QMS if functioning properly.
Suggested Implementation Steps:
- Explain QMS to senior management
- Develop and confirm quality policy
- Identify quality-critical areas in the process. Incorporate into a QMS, adapting as necessary
- Write new procedures to cover quality-critical operations (work instructions, specifications, recipes).
- Set realistic targets
- Train staff in new systems and methods
- Post Audit to review effectiveness of new practices and amend as necessary (on-going, 3 days quarterly). Submit quarterly conformance reports
Sound process and quality control systems are critical to achieving consumer satisfaction through the delivery of high quality, consistent product. Process and quality audits conducted independently by brewing experts on a regular, periodic basis ensure system compliance with set specifications and offer corrective action when required.
First Key assigns experienced and internationally known brewers, process engineers and quality control specialists to conduct independent audits on all process and quality systems and at all stages in the production process.
- To determine if the process is properly designed, defined and documented.
- To determine conformity or nonconformity of the quality system elements with specified requirements.
- To determine the effectiveness of the implemented quality system in meeting specified quality objectives.
- To provide the audited plant management with an opportunity to take timely corrective action to eliminate deficiencies.
- Supplemental objectives to meet regulatory requirements, and/or to achieve certification (ISO 9000 for example) may also be included.
Quality Audits need to be performed on a regular basis. The Audit normally takes two weeks and encompasses a review of process and quality activities. A Conformance Report is prepared and includes recommendations for adjustments. The report results are discussed with local management, corrective actions are agreed, and a time schedule for action is set. Successive audits include a report on completion of the previous audit’s action plan.A sensory evaluation of in process and finished product will be conducted during the audit and reported.