The following is an excerpt from the ANSI/ASQC Q90/ISO9000 Guidelines For Use By The Chemical And Process Industries. The chapters I have chosen deal with the management used by the supplier. 4.1 Management Responsibility INTRODUCTION: This clause of the Standard deals with senior management's leadership in and commitment to quality. Q91-1987 Standard 4.1.1 Quality Policy The supplier's management shall define and document its policy and objectives for, and commitment to, quality. The supplier shall insure that this policy is understood, implemented, and maintained at all levels in the organization. GUIDANCE The supplier's senior management shall develop a quality policy statement. The quality policy may also contain the mission, vision, and guidelines necessary to demonstrate the supplier's commitment to these values. It is an unwritten rule that the policy statement should be signed and dated by the most senior executive, providing the first step in implementing the supplier's quality system (see clause 4.2). This policy should be a control document (see clause 4.5) and should be included in the quality manual. The supplier's management is responsible for communicating the quality policy throughout the organization and for reinforcing organization-wide ownership of the quality clause through day-to-day actions. Clause 4.1.1 in Q91 is identical to clause 4.1.1 in Q92. Clause 4.1.1 in Q93 only addresses defining a quality policy. Q91-1978 Standards 4.1.2 Organization 4.1.2.1 Responsibility and Authority The responsibility, authority, and the interrelation of all personnel who manage, perform, and verify work affecting quality shall be defined; particularly for personnel who need the organizational freedom and authority to: a) initiate action to prevent the occurrence of product nonconformity; b) identify and record any product quality problems; c) initiate, recommend, or provide solutions through designated channels; d) verify the implementation of solutions; e) control further processing, delivery, or installation of nonconforming product until the deficiency or unsatisfactory condition has been corrected. GUIDANCE Management should clearly define the responsibilities, authorities, and interfaces in the quality management system. Often a quality organization chart issued to show responsible functions and critical interfaces of personnel who carry out the activities identified in the items (a) through (e). The quality organization chart need not duplicate the supplier's overall organization chart. Q92 with the omission of design and servicing Clause 4.1.2.2 in Q93 is limited to verification that product conforms to specified requirements. Q91-1987 Standard 4.1.2.3 Management Representative The supplier shall appoint a management representative who, irrespective of other responsibilities, shall have defined authority and responsibility for ensuring that the requirements of this Standard are implemented and maintained. GUIDANCE The supplier's management representative will generally be a high-ranking individual. The management representative may function as the quality assurance interface with the purchaser, sub-contractors, and external certifying bodies. The representative should oversee the supplier's compliance with all aspects of the Standard. The Standard does not require this person to devote full time to this responsibility as long as other assigned activities do not restrict the authority and opportunity to assure compliance with the Standard. Management representative may designate others to handle specific facets of the compliance program. Clause 4.1.2.3 in Q92 and clause 4.1.2.3 in Q93 are identical to clause 4.1.2.3 in Q91. Q91-1987 Standard 4.1.3 Management Review The quality system adopted to satisfy the requirements of this Standard shall be reviewed at appropriate intervals by the supplier's management to ensure its continuing suitability and effectiveness. Records of such reviews shall be maintained (see 4.16). NOTE: Management reviews normally include assessment of the results of internal quality audits, but are carried out by, or on behalf of, the supplier's management, namely management personnel having direct responsibility for the system (see 4.17). GUIDANCE This is one of the most important requirements of the Standard. Management must be involved in the quality system. This requires that management personnel conduct quality reviews. Although it is not specifically required by the Standard, the supplier's management should formally review the operation of the entire quality system at least annually. When major changes to the quality system have been made, more frequent review may be required. Relevant statistical measures of quality and timeliness (see clause 4.20) should be presented as part of the review. Consider corrective actions (see clause 4.14) or redeployment of resources to remedy deficiencies. Records of the review (see clause 4.16) should include recommended actions. Subsequent reviews should examine the effectiveness of such actions. Clause 4.1.3 is identical in Q91, Q92, and Q93. The NOTE (which is not included in Q93) correctly states that internal audits provide valuable information for management reviews. However, the supplier's senior manager, not the quality assurance manager, should select a review panel including representatives from support functions (e.g., technical service, marketing, research, development, and finance), because changes in procedures or resources may be required for corrective action. The management representative (see clause 4.1.2.3) would be expected to coordinate the review meeting. 4.2 QUALITY SYSTEM INTRODUCTION: This clause of the Standard defines the requirements for the supplier's quality system. Q91-1987 4.2 Quality System The supplier shall establish and maintain a documented quality system as a means of ensuring that product conforms to specified requirements. This shall include: a) The preparation of documented quality system procedures and instructions in accordance with the requirements of this Standard; GUIDANCE The standard requires the supplier to have a documented quality system. Read Q94 clauses 4.4 to 5.3 for a complete discussion of quality systems. Two definitions from those clauses are cited: A quality system is the organizational structure, responsibilities, procedures, processes, and resources for implementing quality management. The quality system typically applies to, and interacts with, all activities pertinent to the quality of a product or service. It involves all phases from initial identification to final satisfaction of requirements and purchaser expectations. **** Lori Barnhill, I want to interrupt here and say that the last sentence seems to fall in line with Dr. Tribus' own idea of "what is quality". In his article "Creating the Quality Service Company" he favored a definition that read 'Quality Is Giving People What They Have A Right To Expect.' ISO9000 seems to say the same thing by saying 'purchaser expectations.' **** The scope of the quality system includes assuring the quality of both product and service elements of the purchaser/supplier relationship. The Q91 Standard states in clause 3.0 that the term "product" also denotes "service" as appropriate. Thus, on-time delivery, correct invoicing, and complaint resolution are also important. The Standard requires that the quality system be documented, demonstrating that a formal, organized quality system is in place and providing an authoritative description of the system. An accepted method of documenting the organization of a quality system is through a quality manual. The quality manual is the directory of the quality system. It should describe policy, specify responsibilities, and identify procedures. The quality manual may be corporate or divisional, or it may describe a specific process within a manufacturing site. It is important that the quality manual define the scope of the quality system. A documented quality system may use the concept of tiered documentation, the top tier of which is frequently the quality manual. Occupying the lower tiers would be policies, procedures, and work instructions and records. As a minimum, the quality manual should address all the requirements in the Standard and any other standards related to quality systems as appropriate for the industry and for the supplier (e.g., Good Manufacturing Practices [GMP]). The manual also should refer to policies and procedures related to: 1. Specifications, including: a. Raw materials b. Process c. Product d. Package and label e. Sales 2. Safety system 3. Purchaser service practices, including: a. Order entry system b. Product delivery system c. Billing practices 4. Purchaser relation practices, including: a. Policy for sharing information b. System of analyzing and resolving complaints c. System of determining purchaser's needs. The Standard explicitly requires the supplier to document quality system procedures. Q91-1987 Standard 4.1 Quality System b) the effective implementation of the documented quality system procedures and instructions. GUIDANCE The quality system procedures and instructions should be effectively implemented, as evidenced by (for example): A) Internal quality audit reports B) Quantitative measures of performance C) Management reviews of the quality system D) Quality records. Q91-1987 Standard 4.2 NOTE: In meeting specified requirements, timely consideration needs to be given to the following activities: GUIDANCE Notes (a) through (g) point out items to consider before agreeing to supply product in accordance to the Q91 Standard. The supplier should decide the applicability of each note to a specific business. Q91-1987 Standard 4.2 NOTE (Continued) a) The preparation of quality plans and a quality manual in accordance with specified requirements. GUIDANCE In practice, a quality manual has become a requirement for third party registration. In addition, internal and external audits are more effective with a quality manual as a reference. Note (a) also mentions the preparation of quality plans (see clause 4.4.2). Quality plans may define how the quality requirements will be met for a contract, a class of products, or new products. Other examples might include: Sampling plan Inspection plan New product plan Strategic quality system plan A quality plan may include all the quality system elements; or it may cover only those part of the quality system (specific procedures, testing, methods, and/or work instruction) that are added to or different from those required by the specific contract or class of products. Q91-1987 Standard 4.2 NOTE (continued) b) the identification and acquisition of any controls, processes, inspection equipment, fixtures, total production resources, and skills that may be needed to achieve the required quality; c) the updating, as necessary, of quality control, inspection, and testing techniques, including the development of new instrumentation; d) the identification of nay measurement requirement involving capability that exceeds the know state of the art in sufficient time for the needed capability to be developed; e) the clarification of standards of acceptability for all features and requirements, including those which contain a subjective element; f) the compatibility of the design, the production process, installation, inspection and test procedures, and the applicable documentation; g) the identification and preparation of quality records (see 4.16). GUIDANCE In general, the notes describe the supplier's responsibility to be aware of the condition of processes affecting the quality of product or service. The notes also suggest the supplier should be aware of advances made in technology which could improve its processes. Finally, the notes imply that the supplier should carry out plans for controlling, evaluating, and improving its products, processes, and services, base upon the condition of its processes and available technology. Note that "processes" can be service, manufacturing, or business processes -- virtually any process the supplier has within its company which can affect the quality of products or services. Clause 4.1, Quality System of the Q91 Standard is identical to Q92, clause 4.2 and is briefly summarized in Q93. 4.16 QUALITY RECORDS Introduction: This clause of the Standard discusses the record-keeping system needed to meet purchaser requirements. Q91-1987 Standard 4.16 Quality Records The supplier shall establish and maintain procedures for identification, collection, indexing, filing, storage, maintenance, and disposition of quality records. Quality records shall be maintained to demonstrate achievement of the required quality and the effective operation of the quality system. Pertinent sub- contractor quality records shall be an element of these data. All quality records shall be legible and identifiable to the product involved. Quality records shall be stored and maintained in such a way that they are readily retrievable in facilities that provide a suitable environment to minimize deterioration or damage and to prevent loss. Retention times of quality records shall be established and recorded. Where agreed contractually, quality records shall be made available for evaluation by the purchaser or the purchaser's representative for an agreed period. GUIDANCE The supplier should maintain adequate records to demonstrate achievement of the required quality and to verify effective operation of the supplier's quality system. The supplier may choose more than one medium (e.g., paper, electronic, or microfilm) for record storage. The method must provide timely retrieval of records and security and security from unauthorized access. Whatever medium is selected, the records should be protected from los, damage, and deterioration due to environmental conditions. Document the procedures for all aspects of record maintenance. The supplier should define the types of quality records that need to be kept. The following types of records are specifically referred to in this Standard: Management reviews (clause 4.1.3) Contract review (clause 4.3) Design reviews (clause 4.4.5 a) Acceptable sub-contractors (clause 4.6.2) Purchaser supplied product (clause 4.7) Product identification and traceability (clause 4.8) Qualified process equipment and personnel (clause 4.9.2) Receiving inspection and testing (clause 4.10.1) Inspection and test records (clause 4.10.4) Calibration and measurement assurance records (clause 4.11 f) Test hardware checks (clause 4.11) Inspection and test status (clause 4.12) Nonconformity review and disposition (clause 4.14) Training records (clause 4.18) The supplier should set retention times for quality records appropriate to the type of record. Retention times should be documented (see clause 4.5). Consider these factors in setting retention times: Requirements of the contract with the purchaser Applicable regulatory requirements (e.g., FDA) The stated useful life of the purchaser's product The final sale of the supplier's product Process data are increasing recorded by on-line computer systems in the chemical industry. If these records are used as part of the quality system, the supplier should: Verify that software meets the quality system needs Verify the accuracy and precision of recorded values Screen the records for missing or wild observations Protect old records from being written over by new records Create archives of electronic records to assure recovery when required Clause 4.16 in Q91 is identical to clause 4.15 in Q92. Clause 4.10 in Q93 addresses only inspection and test records required to substantiate conformance with specified requirements. 4.17 INTERNAL QUALITY AUDITS Introduction: This clause of the Standard states that internal quality system audits are essential to maintain the quality system. A quality audit is the principal source (see clause 4.1.2.2) or answers to three critical questions: Are all the detailed provisions of the quality system being carried out as intended? Is the quality system effective in producing the specified quality results? Does the quality system conform to all external requirements that apply to it, such as purchasers' contracts, applicable quality system standards, and government regulations, in addition to the supplier's internal policies and plans? By focusing on the system, quality audits differ from quality control, which focuses on the decision to accept or reject products, intermediates, or raw materials. Quality system audits also differ from management reviews, which review audit reports along with other sources of information to determine how well the quality system is functioning and to initiate any needed changes. While this clause of the Standard does not exclude product and process audits, quality systems audits are the minimum requirement our compliance with Q91. Q91-1987 Standard 4.17 Internal Quality Audits The supplier shall carry out a comprehensive system of planned and documented internal quality audits to verify whether quality activities comply with planned arrangements and to determine the effectiveness of the quality system. Audits shall be scheduled on the basis of the status and importance of the activity. The audits and follow-up actions shall be carried out in accordance with documented procedures. The results of the audits shall be documented and brought to the attentions of the personnel having responsibility in the area audited. The management personnel responsible for the area shall take timely corrective action on the deficiencies found by the audit (see 4.1.3). GUIDANCE An internal quality system audit function begins with a management policy describing its scope, responsibility, and authority, and requiring auditees (audited areas) to cooperate during audits and to carry out corrective actions. There should be written procedures for planning, carrying out, reporting, documenting, and following up audits, and also for selecting, training, and quality auditors. All activities within the quality system should be audited. Prioritized activities by considering: How critical they are of the quality of the product The results of previous audits How difficult the activities are to keep in control There should be a schedule of periodic audits that reflects the priorities; in the absence of other information, audits are usually conducted annually. The lead auditor should be familiar with the standards that apply to the supplier's business. The specific clause to be audited and questions to be answered are determined on the basis of relevant standards, the quality manual, and the history of the auditee. Members of an audit team should have the necessary qualifications and experience to fulfill their roles on the team. The lead auditors should be independent from the area being audited. The team collects evidence during the audit, focusing on procedures, work instructions and records, the facility and equipment, and observation of work being performed. The evidence should show both what is working as intended and what needs to be corrected. An audit concludes with a meeting with the auditee's senior management, at which the lead auditor presents audit observations and overall conclusions regarding the quality system. The formal written report should include the audit date and location, conclusions regarding the quality system's effectiveness and its conformance with relevant standards, and any deficiencies found. The team should give the report to senior management having authority and responsibility to take corrective action and to the auditee's management. The auditee is responsible for determining and carrying out actions or correct the deficiencies. usually the goal is to identify actions that will eliminate the cause of deficiencies and thus prevent their recurrence. The time o complete the actions is agreed to by senior management and the auditee in consultation with the auditors. Management, with the cooperation of the audit team, should follow up to verify and document that corrections have been completed on the item and are effective For more information, see, the example, ISO 10011, Guidelines for Auditing Quality Systems. Clause 4.16 in Q91 is identical to clause 4.15 in Q92. This subject is not mentioned in Q93.