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Supplier Expectation Manual V1.5

by | Oct 14, 2020 | Market Trends & Analysis, Quality Systems

Supplier Expectation Manual V1.5

Introduction

As a supplier to The Blissful Plant Co. LLC (also referred to as Blissful) we consider you an extension of our company, and we seek a relationship that continually meets our quality expectations. This Manual contains expectations for quality and food safety systems for our ingredient suppliers.  It is not intended to be all-­‐inclusive.  The Manual is intended to identify key program components and considerations when developing the quality programs but does not dictate how programs are developed. The execution must be facility specific. Each facility must develop systems that work best for the facility but with our program expectations incorporated into the documented system. The true test of a quality system is defined by its effectiveness and ability to improve processes and prevent failures. The facility should be able to articulate how plant staff verifies this effectiveness and how individual program components meet our expectations. Commitment to a quality program can be demonstrated through the effectiveness of each facility’s process and quality management system.

Many of the expectations are guided by U. S. regulatory mandates and statutes. Blissful reserves the right to modify this manual and its expectations in the event of regulatory changes, changes in the business climate, changes in our customer needs, or changes in our best practices standards in relation to the quality and safety of our finished products. Federal, state, and local statutory requirements shall take precedence over any guidelines presented in this document. It will be the supplier’s responsibility to ensure compliance with all applicable federal, state, and local regulatory requirements of the location where the products are produced and the destination to which the products may be delivered. Notification and/or information regarding regulatory complaints or recall actions directly or indirectly involving our products received by the supplier must be immediately relayed to management of Blissful.

It is recognized that the requirements of structured Quality and Food Safety Systems have evolved rapidly in recent years and will continue to do so. Some elements are essential while others can be developed over time to strengthen and improve the systems. The term “shall” indicates an expectation that is to be in place upon commencement of the business relationship. The terms “should” or “shall develop” indicate elements that need to be developed within 2-3 years by the Supplier if not presently in place. Exceptions may be granted at the discretion of the management of Blissful.

This is a confidential reference source developed for use by our suppliers. The materials and information herein are provided for the exclusive use of our company and approved suppliers which require the information to effectively manage their relationship with Blissful. Under no circumstances should dissemination of the information contained herein be disclosed beyond said parties. This Manual is to be used by suppliers as guidelines to follow. Some expectations may not be applicable to a specific supplier. These variances will be reviewed and noted in writing as allowed for such a supplier.

This manual is intended to assist suppliers in complying with the expectations of Blissful. Nothing contained herein shall be construed to be a commitment to purchase or to impose a contractual obligation. Blissful expressly reserves the right to take any action it determines appropriate relating to its purchasing functions including suspension or termination of any product purchases at its sole discretion. Failure to comply with these guidelines may result in a suspension of purchases and shipments. 

We thank you for the interest you have in working as a partner with Blissful to provide safe quality products for our customers.

Sincerely,

Paul Frantellizzi | CEO

Required Programs

Quality System

  1. The supplier shall develop a documented Quality System that complies with all Blissful expectations and with all applicable government regulations.
  2. The Quality System should be communicated to all appropriate levels of the supplier’s organization.
  3. The Quality System’s effectiveness shall be evaluated by the supplier at a minimum frequency of once per year. Elements of effectiveness include, but are not limited to, the following:
    • Rejected shipments.
    • Late shipments.
    • Complaints received by Blissful attributable to supplier quality.
    • Effectiveness of corrective actions.
  4. Documentation of the quality system reviews shall be supplied to Blissful. 

Training

  1. The supplier shall ensure that employees are knowledgeable regarding current Quality, Food Safety, and Good Manufacturing Practices applicable to their respective responsibilities.
  2. The supplier should maintain a documented training program for new hires for Quality and Food Safety that will include HACCP, Allergens, GMPs, Sanitation and Quality Procedures.
  3. The supplier should conduct annual employee training for Quality and Food Safety.
    • Methods to verify training effectiveness, such as written tests, are recommended.
  4. Records of all training should be maintained.

Traceability / Recall

  1. The supplier shall have a Traceability Program in place that tracks the history of the product from receipt of raw materials to specific finished lots delivered to Blissful.
  2. The supplier’s traceability program shall be able to include and account for:
    • Raw Materials.
    • Finished Product.
    • Rework.
    • Product on Hold.
    • Product in Transit / Storage.
  3. The supplier shall verify the effectiveness of the traceability program a minimum of once a quarter by conducting a Mock Trace.
    • Accuracy of the Program should be 100% ± 2%.
    • The exercise should take no longer than 4 hours. The time should be recorded with the records.
  4. The supplier shall have a lot numbering system and will submit to Blissful an Explanation / Interpretation of the actual coding legend for each product.
  5. The supplier shall have a documented Recall Plan in place.

Crisis Management Plan

  1. The supplier may be required to have a Crisis Management or Business Continuity Plan in place to address specific high-risk situations that have a high likelihood of occurrence.

HACCP Plan

  1. The supplier shall have HACCP plans for all products produced for Blissful.
    • HACCP Plans are specific for each production line, process and/or type of product.
    • Each plan shall address biological, chemical and physical hazards associated with each production line, process, and/or type of product.
  2. Content of the HACCP plan shall include the following elements:
    • A documented hazard analysis.
    • Determination of Critical Control Points (CCPs).
    • Establishment of critical limits for Food Safety.
    • Establishment of monitoring procedures for each CCP.
    • Establishment of corrective action to be taken when a critical limit deviation occurs.
    • Establishment of a record-­‐keeping system.
    • Establishment of verification / validation procedures.
  3. Metal Detection shall be a required CCP.
    • Metal detectors shall be located as near to the end of the process as is practical.
    • Metal detectors shall be calibrated to a minimum 2.0 mm 316 Stainless Steel sample.
    • Use of additional ferrous and non-ferrous samples for calibration shall be at the discretion of the supplier.
  4. HACCP plans shall include the following documentation:
    • Process flow charts for each production line, process and/or type of product.
    • Deviation and Corrective Action Logs.
    • CCP records.
    • Revision Log.
  5. The plan shall include the following prerequisite programs that comply with regulatory requirements where applicable and all current industry practices and expectations:
    • Master Sanitation
    • Good Manufacturing Practices (GMPs)
    • Customer Complaint Program
    • Integrated Pest Management Program
    • Chemical Control Program
    • Trace and Recall Program
    • Allergen Control
  6. The supplier shall provide annual training on the prerequisite programs to support the HACCP Plan.
  7. The supplier shall takes steps to ensure the product is not shipped until all elements of the applicable HACCP Plan have been met.
  8. Risk assessments will be conducted and the Plan updated as needed whenever changes are made to either ingredients or processes.
  9. The supplier shall review its HACCP plan annually.
    • Review by a recognized third party is recommended but not required.

Process Controls

  1. The supplier shall have systems in place for ensuring that their processing and packaging of food products meets all regulatory requirements and Blissful product specifications.
  2. Specific tests and methods may be specified by Blissful. 

Hold / Rework / Release

  1. The supplier shall have in place documented procedures and controls to prevent the inadvertent shipment of non-­‐conforming products.

System Audits

  1. The ongoing effectiveness of the required quality and food safety systems shall be verified by audits conducted monthly by internal personnel and annually by an external Third Party.
    • Third Party audits will be conducted by recognized agencies such as AIB, Silliker, NSF -­‐ Cook & Thurber, or others deemed acceptable by Blissful.
    • Blissful may also utilize their contractors for this purpose.
    • Certification under any of the recognized Global Food Safety Initiatives is desirable by not mandatory.
  2. The scope of each audit shall include the following:
    • Facility Sanitation / Pest Control.
    • Facility Quality Programs.
    • GMP and Personnel Practices.
    • HACCP and Control Point Management.
    • Facility Infrastructure and Maintenance.
  3. Completed third party audit reports shall be supplied to Blissful.
    • All critical deficiencies shall be addressed with a summary of corrective actions that will be supplied to Blissful.
  4. The supplier shall have in place facility security risk control measures to prevent intentional harm to product and process. The applied control steps should be based on risk analysis of exposure to an intentional threat.
  5. Security shall be sufficient to ensure that only authorized personnel can gain access to the facility.
  6. Food Security and GMP policies and procedures should be reviewed annually with all employees and with contractors and visitors when coming on site.
  7. Supplier’s facilities shall be registered with the FDA or their respective country’s relevant regulatory agency as required.

Environmental Monitoring / Microbiological Testing

  1. The supplier shall develop a documented Environmental Microbiological Monitoring Program.
  2. The program shall test at a minimum for salmonella and e-coli.
  3. The program shall include a protocol for responding to positive test results.
  4. This protocol will include informing Blissful of any positive test results and subsequent actions taken.

Transportation

  1. Delivery of material(s) shall be accomplished using suitable equipment designed for transporting such material.
  2. Suppliers shall develop a documented vehicle inspection program applicable to all inbound and outbound shipments.
  3. Vehicles which fail to provide protection to product integrity and/or quality shall be rejected and noted on the vehicle inspection records.

Continuing Product Guarantee

  1. The supplier shall furnish a Letter of Continuing Guarantee stating that all materials supplied to Blissful meet the requirements of the Federal Food, Drug, and Cosmetic Act and subsequent amendments as well as all applicable government regulations prior to the first shipment. The recommended format is included with this manual.
  2. This letter shall include provisions for ensuring the integrity of Organic Certifications and the absence of Genetically Modified Organisms in materials supplied to Blissful.
  3. The document shall be printed either on Company letterhead or display the company logo.
  4. The document shall be signed and dated by an officer of the supplier or other authorized person.
  5. Letters shall be renewed annually.

Certificates of Analysis (COAs) / Retained Samples

  1. The supplier shall submit a Certificate of Analysis for each raw material batch supplied.
  2. A COA shall be received by Blissful and its co-packers prior to or in conjunction with the receipt of any product.
  3. COAs shall contain written test results of all required analysis for each lot using the method specified on the product specification sheet.
    • If a test method is not specified, the COA shall reflect the method used.
    • Test data will include microbiological analysis.
    • A Metal Detection Certificate will also accompany each shipment. This information can be included with the COA or be reported on a separate form.
    • COAs shall also include the following information: Supplier name, address, phone number, contact name and signature, material name and Blissful ID number if applicable, material lot identifier, production date, and supplier purchase order number.
  4. The supplier may be required to submit product samples along with the raw material shipment.
  5. The supplier shall retain samples of each lot for a period of no less than 14 months from the date of shipment.

Kosher Certification (If applicable)

  1. The supplier shall be required to submit a Kosher Statement for each raw material supplied.
    • Certification must be acceptable by the Orthodox Union.
  2. The supplier shall be required to submit an updated certificate before the current certification expires. This is typically on an annual basis.
  3. The supplier shall be required to maintain standards that are compliant with the appropriate Kosher Certification.

Organic Certification (If applicable)

  1. The supplier shall be required to submit Organic Certification for each raw material supplied.
  2. The supplier shall be required to submit an updated certificate before the current certification expires. This is typically on an annual basis.
  3. A supplier shall be required to maintain standards that are compliant with the appropriate Organic Certification.

Gluten Free Verification (If applicable)

  1. The supplier shall develop and implement systems as needed to ensure compliance with gluten-free requirements for each shipment to Blissful.
  2. Verification of meeting these requirements shall be documented on the respective COA. 

Allergen Statement

  1. The supplier shall be required to submit an Allergen Statement for each raw material supplied.

Record Retention

  1. The supplier shall ensure that documentation is available for the purpose of verifying its Quality and Food Safety systems.
  2. These records shall be maintained for a minimum of 24 months from the date of shipment to Blissful.

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