rPeptide Quality Manual

ISO 9001:2015 Standards

Summary:

To maintain our production facility’s quality management system, rPeptide has several internal sub-systems to monitor the various stages of production, post-production, raw materials, and intermediates involved in all final products. All systems are thoroughly documented, strictly followed, and routinely reviewed according to rPeptide’s internal guidelines. The following document outlines a condensed version of rPeptide’s quality management system, which follows the ISO 9001:2015 standard.

• 1-3 – Introduction and scope of the standard.
  • 1: Scope of the standard
    • rPeptide has been serving our customers faithfully for over two decades, and always with a commitment to continuous improvement. With this in mind, we ensure consistency with our products through our quality management system, which further provides a high rate of customer satisfaction. The scope of rPeptide’s quality management system includes all the processes, protocols, and procedures involved with the manufacturing of final products to be sold to our customers from our production facility.
  • 2: Normative references
    • Any statements quoted in this quality manual are taken from the ISO 9001:2015 Standard Manual.
  • 3: Terms and definitions
    • ISO 9001:2015 standard: the most recent set of ISO 9001 standard published in 2015.
    • QMS: quality management system
    • QM: quality manual
    • QC: quality control
    • QA: quantitative analysis
• 4 – Context of the organization.
  • 4.1 Understanding the needs and expectations of interested parties.
    • “Due to their effect or potential effect on the organization’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, the organization shall determine:”
      • “…the interested parties that are relevant to the quality management system.”
        • Interested parties relevant to the quality management system are the customers of rPeptide which have or will have purchased our products or services and rPeptide itself. rPeptide interested parties also include management and employees. We believe that our products can have an impact on our own organization as well as our customers, and the research community.
      • “…the requirements of these interested parties that are relevant to the quality management system.”
        • The requirements for the interested parties regarding rPeptide’s products are product dependent but will be outlined in the product datasheet. Products will have a specific level of purity, which will be confirmed through extensive quality control methods prior to delivery to customers. This requirement for our products will be relevant to these interested parties in that the quality will be monitored at key stages of production and post-production prior to delivery to the customer. rPeptide also operates under a strict rule of shipping products to customers within 24-48 business hours after an order is placed, dependent upon availability and size of product.
    • “The organization shall monitor and review information about these interested parties and their relevant requirements.”
      • rPeptide team members participate in regular strategy reviews, QMS action plans, annual reports, meeting minutes, etc. with management to ensure and demonstrate compliance with our QMS. This process of reviews and reports involves customer inquiries, issues related to product quality, or any challenges related to production that might affect the organization or its customers.
  • 4.2 Determining the scope of the management system.
    • The scope of the quality management system applies to rPeptide’s production facility, and the final products being sold to our customers. The scope of the quality management system is viewed in the context of the issues referred to in 4.1. rPeptide’s internal documentation system verifies the scope as provided in 4.2.
  • 4.3 The quality management system and its processes
    • 4.3.1
      • “The organization shall establish, implement, maintain and continually improve a quality management system, including the processes needed and their interactions, in accordance with the requirements of this International Standard.”
      • rPeptide has a defined set of inputs required and the outputs expected from organizational production processes.
      • rPeptide has determined the sequence and interaction of these processes.
      • rPeptide has determined and applies the criteria and methods (including monitoring, measurements, and related performance indicators) needed to ensure the effective operation and control of these processes.
      • rPeptide has determined the resources needed for these processes and ensures their availability.
      • rPeptide has assigned the responsibilities and authorities for these processes to laboratory and production team members.
      • rPeptide has addressed the risks and opportunities as determined in accordance with the requirements of 6.1.
      • rPeptide has evaluated these processes and implemented any changes needed to ensure that these processes achieve their intended results.
      • rPeptide continues to improve the processes and the quality management system as opportunities arise.
    • 4.3.2 To the extent necessary:
      • rPeptide maintains documented information to support the operation of its processes.
      • rPeptide retains documented information to have confidence that the processes are being conducted as planned. The documented information is retained for at least 5 years and can include customer inquiries, batch records, and quality control data.
• 5 – Leadership.
  • 5.1 Leadership and commitment
    • “Top management shall demonstrate leadership and commitment with respect to the quality management system…”
    • Top management meets with members of the production team regularly to discuss ongoing projects, any challenges, progress updates, and to ensure delivery dates meet expectations. If any issues arise, they can be addressed and corrected immediately.
    • These meetings keep all team members including management updated with current expectations, needs, and challenges, especially those related to production or customer service.
  • 5.2 Policy
    • Quality Statement
      • Whether it be to fill a research gap or have a scientific breakthrough, we are all striving towards a better tomorrow together. We are committed to helping scientists and researchers all over the world by providing high-quality products and exceptional service for Alzheimer’s, Parkinson’s, and other neurodegenerative research areas.
    • Quality Objectives
      • To achieve a high level of customer satisfaction and retention.
      • To provide high quality products to our customers.
      • Minimize extended delivery times.
      • Outline standards for a continuous improvement mindset.
  • 5.3 Organizational roles, responsibilities, and authorities
    • Organizational roles, responsibilities, and authorities are communicated during the hiring process and again during training. Each employee is shown their own role and responsibilities as well as how they fit in with the context of the other members.
• 6 – Planning.
  • 6.1 Actions to address risks and opportunities.
    • “When planning for the quality management system, the organization shall consider the issues referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed…”
    • The issues referred to in 4.1 and 4.2 are continually addressed in our regularly scheduled meetings discussed in 5.1. Risks and opportunities are discussed and addressed during these meetings to ensure nothing is left forgotten and this allows for problem-solving meetings to strategize corrective measures if ever necessary. Once measures are put into place and the plans have been enacted, this is documented in the following meeting agenda/minutes. These measures will already have existed as a part of the quality management system, or they will add to our quality management system for continuous improvement. Quarterly and annual meetings will discuss the effectiveness of any measures established to address possible risks and opportunities.
  • 6.2 Quality objectives and planning to achieve them.
    • “The organization shall establish quality objectives at relevant functions, levels and processes needed for the quality management system.”
    • Quality objectives are product dependent, but all objectives for each product are documented, measurable, monitored, communicated, and updated when needed. Quality objectives are outlined in each process SOP for a given product, measured throughout the processes, and then documented on batch records. Results are then discussed in weekly meetings with management and team members.
  • 6.3 Planning of changes
    • “When the organization determines the need for changes to the quality management system, the changes shall be carried out in a planned manner.”
    • “The organization shall consider:
      • the purpose of the changes and their potential consequences.
      • the integrity of the quality management system.
      • the availability of resources.
      • the allocation or reallocation of responsibilities and authorities.”
    • All such considerations are discussed, and decisions made in the meetings mentioned in 5.1.
• 7 – Support.
  • 7.1 Resources
    • “The organization shall determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system.”
    • rPeptide maintains the necessary resources to operate effectively according to the quality management system. These resources include those related to people, infrastructure, environmental, and raw materials. All inputs have guidelines determined, are documented, monitored, and maintained. rPeptide’s logs and systems are designed to perform these aspects of the QMS, and the resource needs, capabilities, and constraints are evaluated and discussed in regular meetings with management.
    • Specifically, regarding the calibration of equipment: rPeptide does regularly maintain and calibrate equipment, especially as they pertain to the quality of our products as the organization defines quality.
    • Organizational knowledge, experience, and proprietary information is passed along to employees via training exercises and written standard operating procedures.
  • 7.2 Competence
    • Competency standards for potential employees are determined before the hiring process begins and minimum qualifications are set.
    • The competence of employees is ensured through semi-annual training in addition to 3–6-month training periods upon their initial hiring. Each employee also refreshes their knowledge of our systems and procedures by regularly participating in production throughout the year.
    • Employees are evaluated annually, and documents of their performance are retained in written and digital records. If necessary, corrective action is taken to ensure compliance with the QMS.
  • 7.3 Awareness
    • As mentioned in 5.2, awareness of the organization’s quality policy is made through proper communication and setting expectations. These expectations and standards are communicated again through the competence training discussed in 7.2.
  • 7.4 Documented information
    • “The organization’s quality management system shall include:”
      • “Documented information required by [the] International Standard.”
      • “Documented information determined by the organization as being necessary for the effectiveness of the quality management system.”
      • Documented information determined by rPeptide as being necessary for the QMS include SOPs, written system protocols, batch records, and emails pertaining to the QMS. As per 4.4.2, the documented information is retained for at least 5 years and can include customer inquiries, batch records, and quality control data.
• 8 – Operation.
  • 8.1 Operational planning and control.
    • “The organization shall plan, implement, and control the processes needed to meet the requirements for the provision of products and services, and to implement the actions determined in Clause 6.”
    • rPeptide maintains standard processes for the manufacturing of our products according to a specific set of quality standards. These processes also outline the acceptance criteria for products and how to treat nonconformities. The production processes are outlined in SOPs, which also show the required resources for the procedures. Batch records, condensed versions of these SOPs, are filled out for every lot produced to document them.
  • 8.2 Requirements for products and services.
    • The requirements for a product as specified by a customer or rPeptide are communicated through email or by documents such as quotes/PO for recordkeeping. The ability to meet the demand of a product based on supply is also upheld by regular inventory of the products in stock.
  • 8.5 Release of products and services.
    • “The organization shall implement planned arrangements, at appropriate stages, to verify that the product and service requirements have been met.”
    • “The release of products and services to the customer shall not proceed until the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority and, as applicable, by the customer.”
    • The release of products at rPeptide is the designated responsibility of the product specialist, quality manager, or operational supervisor. The procedure for the release of products is outlined in each product SOP and is documented for each lot in the batch record. Delivery documents are also created for each lot, which include a delivery sheet and COAs. These records allow for evidence of conformity and traceability of the products.
  • 8.7 Control of nonconforming outputs.
    • “The organization shall ensure that outputs that do not conform to their requirements are identified and controlled to prevent their unintended use or delivery.”
    • “The organization shall take appropriate action based on the nature of the nonconformity and its effect on the conformity of products and services. This shall also apply to nonconforming products and services detected after delivery of products, during or after the provision of services.”
    • rPeptide has a policy for nonconforming products to address clauses 8.7.1-2. The policy is dependent on the individual quality requirements for each product.
    • In the event a product or batch is nonconforming to our quality standards, the product is segregated from conforming products and identified. Documentation in the form of batch records then records the nature of the nonconformities and any other relevant information.
• 9 – Performance evaluation.
  • 9.1 Monitoring, measurement, analysis, and evaluation
    • “The organization shall evaluate the performance and the effectiveness of the quality management system.”
    • “The organization shall retain appropriate documented information as evidence of the results.”
    • To address the points in clause 9, rPeptide has created several documents to monitor, measure, analyze, and evaluate the aspects of the QMS. These documents include a process interaction chart, risk register, FMEA analysis, customer satisfaction measurement system, quality objectives document, and other related logs. The internal audit also contributes to this process. A combined assessment of these documents provides an evaluation of the QMS performance.
  • 9.2 Internal audit
    • Annual internal audits are done to evaluate the performance of the QMS and ensure it is functioning properly. Other areas included help address the points in clause 9, such as documents which monitor, measure, analyze, and evaluate the aspects of the QMS. These documents are those included in 9.1.
    • A combined assessment of these documents and systems provides an audit of the QMS and provides a snapshot of the health of the system. These audits often use documentation and data which show the aspects of each batch produced, and a final report is generated after each audit for recordkeeping purposes. The results from each audit are then discussed between the operational supervisor and the CEO. If corrective actions are needed for any nonconforming products or activities, or any challenges for production are identified, these are discussed and planned for accordingly.
  • 9.3 Management review
    • “Top management shall review the organization’s quality management system, at planned intervals, to ensure its continuing suitability, adequacy, effectiveness, and alignment with the strategic direction of the organization.”
    • rPeptide’s management review inputs include status of previous management review outputs, any changes to issues relevant to the QMS, information on the effectiveness or performance of the QMS, status of resources, effectiveness of actions taken to address previously identified risks and opportunities, and opportunities for improvement.
    • rPeptide’s management review outputs include opportunities for improvement, any necessary changes to the QMS, resource needs, and documentation as evidence for the results of management reviews.
• 10 – Improvement.
  • 10.1 General
    • “The organization shall determine and select opportunities for improvement and implement any necessary actions to meet customer requirements and enhance customer satisfaction.”
    • rPeptide complies with clause 10.1 by scheduling specific projects on a minimum annual basis to improve products, finding new ways to improve customer satisfaction, reducing, or preventing undesired effects, and improving the performance of our systems.
  • 10.2 Nonconformity and corrective action
    • Clause 10.2 discusses nonconformities in relation to the QMS. When a nonconformity to the quality management system does occur, rPeptide reacts immediately to reduce the impact to our other systems and limit its consequences. Corrective actions are taken to identify, segregate, and control the nonconformity.
    • All evidence and data of the nonconformity and how it is treated are documented and retained in records.
    • The nonconforming event is reviewed to determine the cause and reduce instances of recurrence.
    • Depending on the severity of the nonconformity, instances will be discussed during the management review process and be a focus during the internal audit.
    • If a nonconformity impacts a product, the product is analyzed to determine whether to dispose of it or rework it into a final product which meets our quality standards.
  • 10.3 Continual improvement
    • “The organization shall continually improve the suitability, adequacy and effectiveness of the quality management system.”
    • “The organization shall consider the results of analysis and evaluation, and the outputs from management review, to determine if there are needs or opportunities that shall be addressed as part of continual improvement.”
    • All systems are thoroughly documented, strictly followed, and routinely reviewed. Internal audits are also performed by the operational supervisor to ensure the use of these systems for continuous improvement, and these audits are further reviewed by management. As shown in 10.1, regularly scheduled projects are dedicated to the idea of continually improving our systems and protocols which impact the quality of our products. These projects are scheduled even in instances where the system is already be considered effective and adequate.