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General Questions

1.1 Management and documentation

  • 1.What is the certification status of the company?

  • 2. Is the management system described in full in a management manual?

  • 3.Are Q, S, E, others.. management systems integrated or described separately?

  • 4.Does the documentation cover all levels of the document hierarchy (processes, procedures, specifications, certificates, etc.)?

  • 5.Are the company Processes presented in a form that enables the mutual dependencies and process responsibilities to be identified (e.g. process model, process mapping)?

  • 6. Is the documentation system appropriately communicated and readely accessible (eg IT solutions)?

1.2 Control and traceability of documents, data and records

  • 8.Are appropriate users notified when new documents are issued or existing documents are updated?

  • 9.Are these documents & data available at the right places?

  • 10.Are these documents & data listed (hard / e-) and reviewed?

  • 11.Are there procedures to establish and maintain identification, collection, accessibility, indexing, filling, storage place & time, maintenance and disposition of records, including training, audit, reviews, problems, compliance certificates (MSDS,) and pertinent sub-contractor records, incl records related to Quality ?

  • 12.Are computorised records backed up and stored off site or in a secure environment. Paper records are maintained in a secure environment to prevent loss, damage, deterioration and confidentiality?

  • 13.Are the raw materials, tools, machines, processing aids, SFG and FG identified appropriately throughout the production process?

  • 14.Are processing aids and hazardous materials recorded appropriately?

  • 15.Provided a finished product lot number (given by the auditor), what product identification and traceability information can you provide on raw material lot identification (to what level can raw material components be traced, production process information (tools,...), production equipment used, manufacturing sequence, finished product test results, and shipment information? Approximately how long does it take to provide all these informations?

  • 16.What is the level of detail of traceability (raw materials, tools, FG)?

  • 17. How is the identity and traceability of reworked product/repaired tool maintained?

2. Management responsability

2.1 Management commitment

  • 18. Is the development/introduction of the management system a strategic decision of the company management? (i.e. policies, MBO, budget, strategic plan...)

2.2 Company policies

  • 19.Does the company have written policies for Quality ?

  • 20.Are the policies consistent with UPL policies?

  • 21.Are the policies customer oriented?

  • 22. Do they include : -a commitment to continual improvement, - prevention of accidents -a commitment to comply with the law, local authority regulations and other contractual or market requirements?

  • 23.Are the policies endorsed by top management ?

  • 24.Are policies regularly reviewed in terms of their suitability and effectiveness?

  • 25. To what extend is the work force involved in the policy and decision making process?

  • 26.Are business sustainability and social responsibility taken into account when the organisation defines and/or updates the policies?

  • 27.Are the policies accessible to interested parties and communicated to all employees so that it is understood and familiar at all levels of the organization?

2.3 Planning

2.3.1 Identifying hazards, risk assessment and risk control (aspects+risk management)

  • 28. Is there a method for risk assessment?

  • 29. Is the method is in line with UPL method?

  • .Are risks associated with identified hazards determined by:

  • 36.Are identified hazards prioritised according to their risk?

  • 37. Is suitable and qualified consulting expertise engaged when specialised skill is required to identify hazards and assess risks?

  • 41.Has the company carried out a preliminary quality risk assessment?

  • 42.Has risk assessment identified all necessary Critical Control Point's?

  • 43. Is there a crisis management plan (emergency plan, contingency plan, crisis communication) which includes quality risk?

2.3.2 Legal and other requirements

  • 46. How can the company demonstrate knowledge of and accountability for, applicable regulations, company standards and customer's contracts, to which they are subject?

  • 47. Is there a procedure for recording, maintaining and communicating (to appropriate users) regulations and legal & contractual requirements ?

  • 48.Are there any indications that the supplier is in compliance with established national and local regulations or with contractual specifications?

  • 49.Has the company never been cited for non-compliance with any regulations or contract? If no, when and for what ?

  • 51.Are responsibilities and competences for Regulatory Affairs (regulation watch, compliance check and certification) and PI defined?

  • 52. Is there an inventory of materials subject to regulations or contractual requirements?

2.3.3 Objectives & targets

  • 53. To what extend do measurable goals exist against which progress can be tracked (KPI's, programmes, objectives)? Try to assess the relevance and level of challenge in any programmes.

  • 54. Is there a process for continuous setting and review of objectives of each individual level (i.e. KPI, MBO)?

2.3.4 Quality program

  • 55. Do programme(s) exist and are they current and enforced?

  • 56. Do these programme(s) specify the required activities and resources with specific responsibilities, the means and the time schedules in order to achieve objectives and targets?

  • 57.Are all hierarchy levels and the relevant functions included?

  • 58.Are the programs systematically reviewed and updated at planned intervals?

  • 59.Are the programs adapted to suit the changes that may occur in the activities, products, services or working conditions of the organisation?

  • 60.Are the applicable objectives integrated in the program(s)?

2.4 Responsabilities, roles

  • 61. How well does the organisational structure define quality responsabilities and authorities?

  • 62.Clear organisational charts and job accountabilities are defined. Back-up personnel are appointed for key positions.

  • 63.Quality responsible has been appointed and is a member of the Company Management?

  • 64.Quality responsible has competence and authority to implement the system(s) and report on it?

  • 65. Do these procedures provide the availability of appropriate instruments for top-down communication and vice versa as well as for any communication with third parties affected/concerned ?

  • 66.Are changes in the activities and related effects communicated to the interested parties?

  • 67.- included within the development and review of the risk management policy and procedure,

  • 71. Is external feedback systematically evaluated and used to improve the process?

2.6 Measurement, monitoring, analysis (statistical method)

2.6.1 KPI, PPI

  • 74.Are there measures (KPIs) utilized to assess performance and drive process improvements.

  • 75.Costs of the Quality system are known (Prevention, Appraisal, Failures)?

  • 76. Is there a process for describing the procedures on how data is collected and analyzed?<br>.Is the scope of the data collection and analysis sufficient to:

  • 77.- ascertain the system effectiveness,

  • 78.- ascertain process reliability and suitability,

  • 80.- ascertain agreement with the legal and stakeholders requirements,

  • 81.- ascertain all processes and product/service compliance,

  • 82.- evaluate suppliers?

  • 83.Does the system identify the critical success factors of the realization processes, which influence the fulfilment of the requirements for product/services (CCP) ?

  • 84.Are the procedures appropriate for monitoring Quality Incident?

  • 85. Is there evidence that these KPI's are reviewed by the management on a regular basis?

2.6.2 Audits (internal, external)

  • 86.Have internal audits been conducted?

  • 87.Are audits conducted according to the any reference standard?

  • 88.Describe your process for conducting internal/external audits (planning, scheduling, frequency, etc.)

  • 89.Are the audit intervals appropriate and are the audit results taken into account when producing the program?

  • 90.The company has a program to audit affiliates/sister companies

  • 91.Are the auditors sufficiently qualified and independent?

  • 92.Has the company been audited by customers?

  • 93.Are the findings that are made during the course of the audit recorded and the competent personnel responsible informed accordingly?

  • 94.Are the required corrective actions done, reviewed, checked on effectiveness and documented on the basis of the audit results?

  • 95.Are the findings and actions communicated across the group/organisation ?

  • 96.Does the company have a program to audit suppliers?

  • 97. Are audits conducted according to the planning?

2.7 Management review

  • 98.Are the management systems, strategic plan, policies, programs and objectives reviewed periodicaly?

  • 99. Is there a documented review of the outcome of audits, client satisfaction, client complaints, employee satisfaction, product/service quality, non-conformance costs, CCP, adherence to requirements in respect of environment, safety and legislation as well as the evaluation of the financial results and the status of the improvement measures?

  • 100. Is a process for continuous improvement in the management system and the company's performance defined and implemented?

  • 101.Does the management review lead to an improvement program?

2.8 Preventive & corrective actions, improvement

  • 102.Are there processes or tools to prevent incidents, nonconforming products, equipments, services?

  • 103.What type of analysis is performed on records and customer/stakeholders complaints? (e.g. Pareto charts, trend analysis, control charts, Ishikawa, FMEA...)?

  • 104. Is there monitoring of preventive and corrective actions?

  • 105.Are all the inputs taken into consideration (audits, complains, incidents, alerts, near misses, ...)?

  • 106. How is the effectiveness of corrective action evaluated?

  • 107.Are all corrective actions from last UPL audit corrected as per time frame agreed on last audit corrective action plan?

  • 108. Is there a process to prevent the immediate (prior to risk analysis) recurrence of an incident or non-conformity?

3. Resources

3.1 Resources availability

  • 109.Does the management provide the necessary resources for the implementation, control of and improvement in the management systems?

3.2 Support Processes

3.2.1 Human Ressources

  • 110.Are job descriptions available for all relevant roles

  • 111.Are job descriptions reviewed when necessary (procedure exists, documented evidence)

  • 112.Job description contains necessary competences and skills (professional (and related regulations), Quality, aspects are considered and adapted to each role of the organisation)

  • 114.Are assigned personnel competent on the basis of training, skills or experience?

  • 115.Induction programs are established systematically ("role change", refreshing sessions (frequency?), deputies, temporary employees & contractors as well)

  • 116.There is a system for training needs evaluation

  • 117.There is a system to measure employee satisfaction

  • 120.Does the training ensure that all employees are aware of existing or potential consequences for their work activity in the event of failure to comply with the instructions,

  • 121.Deputies, back-ups and succession plans are established

  • 122. Is the training properly documented (docs signed by both parties and records are maintained as necessary e.g. on Quality topics)

  • 123. Is the training adapted to all employees (language, method, visuals,...)

  • 124. Training needs, performed, effectiveness and objectives are reviewed on a regular basis

  • 125.Does the company evaluate the effectiveness of training?

3.2.2 Technical support (infrastructure)

  • 127.The machinary, equipment, infrastructure show a suitable state of condition that will not adversely impact product quality, employee OHS or the environment.

  • 128. Are there inspection, cleaning, and sanitizing procedures? (for raw and in-process material storage vessels and containers, processing equipment, and material delivery systems to include pumps, conveyors, hoses, discharge lines, containers, and vehicles)

  • 129. How adequate are storage areas and facilities?

  • 130.Have any requirements for laboratory environmental conditions been determined for impact on measuring equipment? How are these conditions monitored and controlled?

  • 131. Is a preventive equipment maintenance program in place?

  • 132. To what extend does the supplier document tool wear and utilise it in preventive maintenance?

  • 133. Is there management of spare parts (critical ones) ?

3.2.3 Quality, Safety, and Environment

  • 134.Are Safe/Standard Operating Practices (related to QUALITY) available at the working place?

  • 135.Are Inspection frequency and size established on the bases of process capability and/or risk assessment (supplier recommendations, regulations, norms, customer specifications)?

.3.2.4 Finance and Controlling

.3.2.5 IT

  • 142.Does the company have an appropriate data and information management (hardware, software)?

  • 143.Does the company have for IT an appropriate crisis management plan and backups ?

  • 144.Does the company have a clear policy for data security (access rights, employees, contractors, temporary work, frirewalls, hackers) ?

  • 145.Does the company follow UPL Standards ?

4 Implementation and operation

.4.1 Operational control

4.1.1 Sales

  • 154. How is the client notified if contractual agreement can not be met.

4.1.2 Product development

  • 167.Are there any restrictive patent or agreement ?

  • 168.Are all Q, aspects considered at the development stage (incl. Raw materials, waste, disposal, obsolete tools) ?

  • 169. Is the client informed about potential restrictions/limitations in the usage of the good or service due to the development stage?

  • 170. Is design/development verification carried out to check and document whether the requirements have been met?

  • 171. Is the know-how stored appropriately after the design and development project has been terminated/completed?

4.1.3 Production & Logistique



  • 173. Do purchasing documents specify clearly the product or refer to a detailled specification sheet?

  • 174. Do purchasing specs define clearly quality, quantity, timing, purity, and regulatory requirements?

  • 175.Are suppliers periodicaly evaluated, audited and do they get feedback?

  • 176.Are alternative/backup raw materials, tools and suppliers submitted for approval for Quality?


  • 177. How are incoming materials received (tanker, rail car)? Are incoming raw material carriers dedicated to specific products? Describe raw material carrier inspection procedures. Are inspection procedures documented?

  • 178. How do you determine that incoming materials conform to specifications (COA, sensory evaluations, standard physical and analytical analysis, compositional analysis, and microbiological analysis)?

  • 179.Are COA's, supplier test data and/or your incoming test data evaluated against product specifications? Describe the process of reviewing COA's. When discrepancies are found between COA's, incoming inspection, and specifications, describe the steps taken for resolution?

  • 180.Are material audits conducts to verify conformance to COA's? What is the frequency of these audits?


  • 193.Are the employees aware of the competencies and methods of approach to rectifying the deviations?

  • 195.Are inspection records kept?

  • 196.What test data or COA is currently provided to UPL?

  • 197.Can all or a part of the manufacturing be subcontracted ? If yes, what are the checks ?

  • 199. How do you verify that only approved products/services are shipped/delivered?

  • 200.Are responsibilities for status verification clearly defined?

Storage Distribution

  • 202.The infrastructure and transportation means show a suitable state of condition that will not adversely impact product quality, employee OHS or the environment.

4.2 Operational support

4.2.1 Control of testing and measuring devices

  • 204.Are all test materials and equipments systematically monitored, calibrated and maintained on a regular basis ?

  • 206. Is the verification of the test material and equipment based on acknowledged national or international standards? Otherwise, the basis used for calibration shall be recorded.

  • 207.Who is responsible for performing calibrations and maintenance of inspection, measuring, on-line control and test equipment? Is this person properly trained?

  • 208. How are calibration records maintained?

  • 209. How is calibration status identified for equipments or instruments?

  • 210.When equipment is found out of calibration, is the validity of previous inspection assessed and documented?

  • 211. Is the equipment identified accordingly?

  • 212.What are the backup solutions when an equipment is out of calibration/service?

  • 213.Are all inspections and test methods carried out according to defined procedures and methods? Are results compared to specification for identifying nonconforming products?

  • 214. How comprehensively are analytical methods documented and applied?

  • 215. Do you perform routine calibration checks with working standards between scheduled calibrations? Are these checks documented?

  • 216.Have any requirements for laboratory environmental conditions been determined for impact on measuring equipment? How are these conditions monitored and controlled?

4.2.2 Treatment of non conformity, complaints & accidents

Raw materials, tools,services

  • 217.Are there defined procedures which stipulate the responsibility and authority regarding the handling and analysis of accidents, incidents, non-compliance (non-conformities) and the introduction of corrective and preventative measures?

  • 218.Are appropriate measures initiated in the event of non-conformities being discovered following delivery/commissioning of the products/services (incl. recall process as required)?

  • 219.Is there a system for reporting non-conformance, which ensures that the competent departments are informed of the type and extent of non-conforming products and take the necessary decisions?

  • 220.Are corrective actions followed? Is effectiveness of actions undertaken checked?

  • 221.Is there a process for the control of non-conforming products/services defined and implemented?

  • 222.Are non-conforming products/services identified as such and picked out?

  • 223.Do you have a segregated nonconforming holding area? If so, summarize how nonconforming materials are inventoried and reconciled.

  • 224.How do you verify that reworked product conforms to specifications?

  • 225.Have you had any products or raw material recalls?

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