Optimize your quality processes
In an evolving regulatory context and a search for quality performance, your quality systems are never immutable. 5m Partner helps you with the necessary upgrades and adjustments. 5m Partner helps you with the necessary upgrades and adjustments.
As part of your quality processes optimization, we offer the following services:
- Deviation and CAPA management,
- Change control,
- Documentation management,
- Staff training / qualification process
- Control strategy (product, environment…) during your products life cycle,
- Annual Product Reviews,
- Internal and supplier quality audit program,
- Validation and revalidation strategy,
- Risk assessment,
- Out Of Specification (OOS) and Out Of Trend (OOT) results management,
- Reagents management…
Based on a comprehensive grasp of your objectives and business, regulatory, and product specificities, the 5m Partner methodology is built on the following 3 steps:
- Evaluation,
- Simplification
- Optimization of your quality processes.
To support you in your quality optimization projects, we put at your disposal:
- A pragmatic and smiling approach to quality,
- Perfect understanding of your business regulations,
- Technical, organizational and regulatory expertise,
- Experience with quality processes related to your products,
- A solution-oriented approach to offer you the support format perfectly suited to your profile and your requests.
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Meet the expectations
inspectors and auditors
Are you regularly inspected and audited? 5m Partner supports you in the preparation, during audit and/or inspection, in the construction of action plans and responses.
We offer you an "à la carte" assistance menu:
- Preparation of your audits and inspections with:
- Gap analysis to assess the compliance of your Quality Management System with standards and quality requirements,
- Skills development and coaching of your teams: regulations, specific inspection / audit requirements, behavior…
- Presence and back-room assistance during audits / inspections,
- Construction and deployment of your remediation and compliance plan,
- Writing responses to auditors and inspectors…
To enable you to meet these expectations, we rely on:
- The experience of our consultants who have extensive practice in inspections and audits and therefore: the type of deviations they generate, the stress they produce and the preferred wording in responses (including in English) to associate
- Effectiveness and mutual understanding of messages,
- Fluidity of communication,
- Serenity of exchanges,
- A very ground-based and practical anchoring of the proposed solutions: neither too complex, nor too ambitious, nor too simplistic,
- Responses systematically studied with you to close the gaps while taking into account your constraints,
- Knowledge of regulations and their interpretation to perfectly target expectations.
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Manage the change
Your products, your markets, your premises or your processes are evolving and you want to measure and control the impacts of these changes. 5m Partner supports you and helps you make the right strategic and regulatory choices ...
To organize and control the change, we offer the following services:
- Skills development and coaching of your teams:
- Particularities and regulatory requirements linked to this development (product, market, premises, processes, etc.)
- Practical and organizational consequences of the envisaged change,
- Gap analysis to assess with you the necessary changes to your Quality Management System according to the planned change,
- Co-construction and deployment of integration and compliance solutions adapted to your changes, in accordance with your change control process:
- Assessment and analysis of the impact of the change,
- Change planning,
- Focused quality assistance for the design of your products, markets, premises and processes to be modified,
- Writing of your users’ requirements and specifications,
- Preliminary project files review,
- Updating your documentation in connection with the change…
Based on an appropriation of the novelty to be implemented, the identification of the expected result and the taking into account of your objectives, our methodology is based on:
- The definition of the scope of the change and its impact,
- The construction of the associated action plan,
- The support in the implementation of the project and the deployment of practical solutions.
To support you in change management, , we rely on:
- The experience of our consultants who have extensive experience in controlled quality changes,
- Knowledge of quality and business regulations and their interpretation to perfectly target the impacts of your future changes,
- “A la carte” assistance according to your changes, your expectations and the availability of your teams,
- Action plans systematically studied with you to:
- Control your changes while respecting your quality procedures,
- Reconcile quality and efficiency.
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Accompany the novelty
You are going to be producing for a new market. You are integrating new products or new processes on your site. You have to build a new workshop / room / laboratory? 5m Partner supports you and helps you measure the quality and regulatory impacts of these new features.
To enable you to effectively implement these new features in compliance with applicable quality requirements, we offer the following services:
- Skills development and coaching of your teams:
- Quality standards applicable in the context of novelty,
- Regulatory specificities and impacts of this novelty (product, market, premises, processes, etc.),
- Practical and organizational consequences of the planned novelty,
- Technical and regulatory expertise in your new markets, products and processes,
- Gap analysis and identification of the adjustments necessary for the quality compliance of your projects,
- Co-construction and deployment of solutions for implementing your novelty: markets, product, process, …
- Assessment and analysis of the impact of this new market / product on your quality organization,
- Assistance in the design, project supervision, acceptance of new premises, equipment,
- Project planning and assistance in writing a master plan,
- Proposals for adapted solutions,
- Identification of potential suppliers and quality assessment of the proposed solutions,
- Writing of your users’ requirements and specifications,
- Preliminary project files review,
- Updating your documentation in connection with the novelty…
Based on an appropriation of the novelty to be implemented, the identification of the expected result and the taking into account of your objectives, our methodology is based on:
- The definition of the scope of the novelty and its impact,
- The construction of the associated action plan,
- The support in the implementation of the project and the deployment of practical solutions.
our assets are:
- The search for concrete solutions perfectly suited to your projects and needs,
- The technical, organizational and regulatory expertise of your quality projects,
- Senior consultants with experience in the deployment of quality novelty,
- A pragmatic approach to regulatory quality and projects,
- Support adapted to the new features planned, your needs and the availability of your teams.
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Our references
News
Pour en savoir plus avec 5m Partner, venez suivre la conférence d’Hervé TASSERY sur « Le top 5 des écarts entre les exigences de l’ISO 22716 (BPF cosmétiques) et celles du CSAR, le référentiel chinois ».
RDV à Lyon pour A3P cosmétique le 13 juin 2024
Vous connaissez les exigences réglementaires et les attentes de vos autorités de tutelle, mais vous vous demandez souvent « Mais comment font les autres ? ».
Au programme de 2024 avec 5m Partner, la découverte de PCM® ou Process Communication Model, un outil pour faire la différence dans votre communication au quotidien 🚀 …
Pour en savoir plus, c’est par ici…
