Conducting an Effective cGMP and Quality Systems Audit

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[ 本帖最后由 08111832187 于 2019-5-6 16:06 编辑 ]\n\nConducting an Effective cGMP and QualitySystems Audit
A sponsor's guide to the auditprocess

Shamik Pandit and Marcia Gartzke

One of the first questions to be asked before conducting anaudit is: Why? This fundamental question constructs a premise for the auditorwho plans and conducts the audit. Quality and compliance audits have differentpurposes and the answer to the question of "Why?" will define thescope and the type of the audit. This article is addressed directly to theauditor in an attempt to provide some fundamentals about the process ofauditing. [Editor’s note: This is a departure from Contract Pharma’s stylemanual, but I’ve elected to go along with it on the basis of the article’s generaltenor. That noted, future contributors should avoid use of the second person(i.e., "you"), as well as the aforementioned "win-winrelationship.".]

Generally, audits can be classified as follows:

1. New Contractor Audit

2. Routine Audit of an Existing Contractor

3. For Cause Audit

New Contractor Audit
A sponsor conducts a new contractor audit if the company isthinking about contracting with a new provider and wants to find out if thecontractor is compliant and capable of meeting quality and compliancerequirements. The audit style here must be comprehensive so that the sponsordevelops a broad but full understanding of the contractor’s compliance andquality systems. Some of the key questions you want answered by this audit are:

1. Howl ong has the company been in the business?
2. What are the company’s management philosophies towards quality and compliance? Arethey proactive, reactive or retroactive?
3. What is the company’s organization structure? Does it have an adequate talent base?What is the reporting structure? Is the Quality unit independent?
4. Does the company have the resources to manage your particular product (i.e.,manufacturing, packaging or testing capacity, equipment, tools and an adequatepool of skilled personnel)?
5. How is the company’s track record in quality and compliance? Has managementreceived any warning letters, participated in recalls or signed any consentdecrees?
6. Is this company owned by a larger company? If so, what and how is therelationship?
7. Is the company financially stable?
8. How do your company’s peers in the industry view this company?
9. How will your product impact this company’s business processes?
10. Is the company a "pure-play" contract service provider or does it haveits own products? If the latter, what is the ratio of these businesses?
Routine GMP and Quality Systems Audit:
The mission for this type of audit is verification of thecontractor’s quality and compliance systems. You must determine if thesesystems have been maintained or whether any changes in the management, shiftsin the company’s business focus or product spread have created new problems.

Routine audits will have no real value if the contractor andsponsor have not agreed to a corrective action plan from the previous audit orhave been working on them. Further, these audits could become mindless,time-wasting exercises if the sponsor finds that it is repeatedly receiving thesame presentation from the contractor with no measurable shifts in qualityindices.

Some ofthe questions that you would want answered for routine audits are:
1. Has the contractor carried out all the corrective actions noted in the previousaudit? If not, why not?
2. How many deviations or investigations have occurred since the corrective actionswere implemented?
3. How many employee or process errors have occurred since the last few significantchange-controls?
4. How many rejections have occurred? What is the scrap rate?
5. What is the employee turnover rate? Has the company lost any talent base?
6. How are the quality and compliance initiatives viewed within the company? Does ithave top management support?
7. Has there been an increase in the workload or the capacity of the company’sproduction or testing activities?
8. Has there been any regulatory action against the company? How is the companymanaging it?
9. Hast here been any change in ownership of the company?
10. How significant is your business to the contractor and what is its attitude towardthat business?

You may want to request a "State of the Business"report from the contractor’s senior management to answer these pertinentquestions. These summaries should be an integral part of the routine auditreport.

During the routine audit you should allocate approximately10 –20% of your time in verifying the corrective actions and the rest inauditing other significant areas. If you see that some of the correctiveactions are effective and show good results, do not hesitate to mention that tothe company’s management. A well-placed appreciation will win lots ofcooperation from the contractors.

For Cause Audit
These types of audits can be either very simple or verycomplex; there is usually no middle road. If the audit is related to onespecific system, you may be able to conduct a short-focused audit in that area.If the cause of the audit is very serious, such as an FDA action against thecompany, a pre-approval inspection for your product, a recall of your productor a major rejection involving critical systems, you need to conduct a verythorough audit.

Typically, such a complex audit requires amulti-disciplinary audit team. While the scope of the audit is intensive, it couldbe well managed if you have strong team of auditors that is managed by adisciplined and knowledgeable lead auditor.

Some ofthe key questions you need answered for this type of audit are:
1. What are the key objectives of this audit?
2. What is the timeline for assuring the closure to all the findings in the audit?
3. Does the contractor have enough resources (time, money, tools and talent) to manageall the corrective actions in the time it is required?
4. What resources can your company offer to the contractor to implement the correctiveaction plan?
5. Is it all worth it?

This last question is usually a senior management decision,based on your audit team’s recommendation.

Challenges of a Contractor Audit
The major challenges of a contractor audit are:

Definingthe roles and responsibilities: Not having a clear agreement on auditobjective and role definition will cause several problems during the auditprocess. While the auditor should strive to maintain control during auditing,you must refrain from going out of bounds.

It should be clearly established up front that thecontractor is ultimately responsible for serving the sponsor’s business needswhile observing the laws of the land. It should also be established that yourcompany does not have unlimited access to all the information regarding thecontractor. This is especially true if the contractor serves many customers. Asking a contractor to establisha new set of rules specifically for your company is asking for failure.

However, it is your job as a customer to establish these clear auditguidelines in your pre-audit letter. Some companies conduct a meeting todiscuss these audit objectives and use the minutes of the meeting to plan theaudit.

Focus: Maintainingfocus during an audit is a challenging task. People tend to go off ontangents, moving to uncharted waters or toward small talk. While someoff-tangent conversations are interesting, the auditor must maintain control bykeeping the focus on the objectives at hand. Conversely, the auditor may wantto spend some time off on a tangent, which may turn out to be an important areaof cGMP compliance. In short, you must balance your time and attention on an area depending on youroverall audit objective.

Authority: Occasionally power struggles may arise during the audit. Yourhost may want to steer you in one area, while you may want to spend some moretime in another. If you have a valid reason to prod, you should do so politelywhile explaining your reasons to your host. Conversely, you must make sure notto get carried away just because the item was on the check-list or because itis your pet area.

Businessparadigms: As an auditor, you must keep in mind that your company’sbusiness is not always the main business of your contractor. For example, yourcompany may have a specialty product that is typically manufactured by anon-food or a non-drug contractor, where you may be discussing rules andregulations with which your contractor is unfamiliar. In those instances, youmust educate your contractor about your needs and provide support when andwhere necessary.

Planning an Audit
To put it simply, no auditor wants to be at a contractor’ssite for any more time than is needed to complete the objectives of the audit.A lack of planning will result in wasted time and efforts on both sides. Forexample, if there are documents that you can review ahead of time and if yourcontractor is willing to supply you with them, you should try to review them atyour office, rather than spend time doing so during the audit.

Otherthings to plan are gathering and previewing the summary of all the problemsencountered since the last audit. For example, you should try to reviewfollowing items:

•Previous audit reports and the contractor’s response;
• A list of rejected lots and the investigations associated with them;
• All laboratory OOS notices since the last audit. You should include OOS noticesrelated to facilities and processes, not just the batch-specific testing;
• Change-Controlsummary;
•Adverse Event reports;
•Stability Failure reports;
• Scrap and waste reports;
• Last two FDA-483s or Warning Letters, if applicable;

Typically, the last few years’ annual product reports cansupply the information listed above, however, it is usually beneficial toreview the most current events.

Scheduling the audit is another critical area. Your scheduleshould leave you enough time to conduct the audit without becoming a burden onyour contractor. You should try to provide at least a month’s notice so that the contractor isaware of your audit schedule and your objectives. A month gives the contractorenough time to plan for the audit and schedule the right personnel to beavailable for you when you get there. (Another school of thought might say thattoo much advance notice allows the contractor to superficially "straightenout" the site. However, a good audit team should be capable of checkingfor systematic improvements and ignoring the superficial ones.)

Pre-Audit Assessment
Pre-Audit assessment is very critical in determining theaudit’s overall purpose and scope. A review of all the items listed in theplanning section will offer a good understanding of the contractor’s qualityand compliance shoreline. You must be careful not to form any strong opinionsabout the contractor during this pre-assessment. Sometimes those biases, goodor bad, will defeat the purpose of the audit. In short, the pre-auditassessment while critical in planning, it is not meant to replace the audit.

Audit Standards
An appropriate set of standards is critical to conduct aneffective audit. Use of the wrong standards or standards defined by vague andsubjective interpretations can cause potentially explosive situations during anaudit.

A typical list of standards include:

• Published government standards (e.g., Code of FederalRegulations);
• Your company’s corporate policy or requirements;
• Specifications;
• Industry standards and guidelines.

If the contractor is manufacturing a drug, use the drugstandard. Don’t impose inappropriate standards on a contractor; sometimes, yourinterpretation of standards may be necessary for your particular product orbecause of company policy, but it may be more than what the contractor islegally required to do. In these instances, identify those requirements clearlyto your contractors, with an acknowledgement that you are asking them for morethat they are required to do. In some instances, the sponsor may have to pay apremium for the contractor to meet those requirements.

In other instances, the contractor may only be willing to dothe bare minimum. You may have to get your purchasing department involved tohelp arbitrate such standards. In the cGMP world, though some requirements arespecific, many others are broad and subject to interpretations. Fortunately,they are all based on common sense.

In most cases however, the contractor will know what is theright thing to do but may be hampered by financial or political reasons. Theauditor’s job is to convince them (or, better yet have them convincethemselves) that a penny invested in prevention systems will save a dollar’sexpense in corrective systems. An additional incentive for contractors is that,if they a have a good reputation, their business will grow and they may be ableto charge more for their services (not to you, of course!).

Agenda
Your agenda is the blueprint of your audit objectives. Itshould include all the details that your contractor should know to help preparefor the audit. The itemsin the agenda should be specific with timeframes assigned so that yourcontractor may have the responsible person in that area available.

Where possible, you should avoid going off-site for lunch, unless your auditteam will use that time to discuss observations confidentially. Also, avoidaudits on Fridays and Mon-days. Typically those are the days when people takeoff, so important personnel may be absent. Additionally, Mondays are usuallyvery hectic for most businesses. The contractor may need some time on Monday toget some of its real work done. Remember, you are a guest of your contractorand the audit places a significant amount of strain on the contractor’sresources, so choose the agenda items wisely.

Selecting an Audit Team

A typical audit team usually contains two to three people.More members would be cumbersome for both you and your contractor to manage.The team must have a lead person. A lead is not necessarily the most seniorperson, however; it is more important that the lead has the skills to steer theaudit towards it objective and organize all the activities.

Usually, the team will include a technical person, a compliance person and aquality systems person. The collective experience of the team must becomplementary, not repetitive. A strong lab person can complement the skills ofa strong technical person and a quality systems person. The personalities ofthe team members are very important. You must avoid people with combative and argumentativepersonalities in your team. Of course, this is not to say that you avoid"pleasantly persistent" people.

Pre-audit Planning
A pre-audit meeting may be necessary if you think yourcontractor needs it. Usually this meeting is conducted a week in advance toconfirm audit dates and objectives. A telephone conference is usuallysufficient. The key objective of this meeting is to let the contractor know ofany modification in audit objectives or request any items that the contractorcould send ahead of time to make the audit run more efficiently.

Conducting and Audit
Audit roles and code of conducts: Etymologically, the wordaudit is related to the word listen. An auditor’s key role is to ask open-endedquestions and listen to the response. Review of procedures, data andverification of actual activities at the workstations should supplement this"listening." An audit is not meant to be unpleasant for either theauditor or the contractor. There is no reason why the audit can’t be afriendly, pleasant and effective activity. One needs not carry an impassive orsolemn face all the time during the audit. At the same time, audit is not afrivolously everyday activity. It should have the intensity it deserves but nomore. At all costs, you must avoid turning the audit into an interrogation (or,worse yet, an inquisition).

You must remember that you are representing the sponsorcompany during the audit and, as such, must follow all the rules that yourcompany dictates in a professional work environment. Avoid participating inoff-color jokes or being overly casual, while respecting your contractor’sproperty and always asking for permission before touching anything at the site.If your contractor has any visitor policy, observe it to the letter.

Audit Approaches: Pros and Cons
There are a couple of approaches to conducting an audit. You may conduct a standardchecklist audit or use the checklist as a reference document only.Checklists have some advantages, but in the long run they tend to restrict theauditor to the items in the list. An effective auditor makes sure that all the critical areas are coveredat least once, and is keenly aware of areas that may not be included in thechecklist.

Checklist – Eight Major Areas
Whether you use a checklist or not, the following areasshould be covered. Please note that this list is not all-inclusive and shouldnot be treated as such.

Personnel& Organization:
People make an organization. Both sponsor and contractor aredependent on their skills, knowledge and training. Some of the questions anauditor should ask about personnel are:

1. Dot hey have adequate personnel?
2. How do they hire their people?
3. Do they have a steady supply of employees?
4. Do they use temporary employees? If so, what is their role?

5. What sort of training (cGMP and job-specific) is provided? Is the trainingdocumented?
6. Can they read, write and speak the language they must use to do their job with?
7. How do they verify the personnel’s basic literacy in the language used?
8. Who has the authority to accept or reject the product?

Manufacturingand Packaging
1. Does the contractor have a master batch record system, which details all thecritical manufacturing and packaging processes?
2. Does the contractor have adequate equipment of appropriate design? Is the equipmentin a good state of repair?
3. Are the manufacturing and packaging areas of appropriate design and do they haveadequate space?
4. Is the equipment maintained regularly?
5. Does the major equipment have a usage, cleaning and maintenance log?
6. Are the personnel in the manufacturing area following cGMPs?
7. Is the area classification, such as specific air pressures and air exchanges,monitored and maintained?
8. Are the gauges and instruments used to monitor the manufacturing and equipmentprocess calibrated and traceable to NIST?
9. Is the equipment easy to clean?
10. Is there an overall system to report mechanical or process failures? Is QAinvolved in decision making?

QualityControl
1. Is the quality control unit independent of manufacturing operations?
2. Are all the lab procedures validated where applicable?
3. Is there an adequate system of sampling, testing and reporting test results?
4. What is the process of handing out of specification (OOS) reports?
5. Is the laboratory equipment suitable for the testing? Is it calibrated and in agood state of repair?
6. Are the laboratory systems (e.g. information system) validated?
7. Are the personnel qualified or certified before they perform a test?
8. Are the reagents and standards appropriately labeled and stored?
9. How does QC handle obsolete standards and reagents?
10. How are changes to test methods and equipment managed?
11. How are the results recorded? Does QC have an informal reporting? Is the datatranscribed from scrap paper? Are the results validated or verified?
12. How long is the data stored?
13. Are there laboratory notebooks with numbered pages?
14.Does QC have a deviation procedure? How does QC determine and validate human orprocess errors?
15.Does QC have a final authority to accept or reject a lot?

MasterValidation Program
1. Does the contractor have a Master Validation Program?
2. Does it include all the critical equipment, systems and processes in the company?
3. Does the contractor have a summary of the status of all the individual validationprograms?
4. Does the contractor have the technical and compliance expertise in managing themaster validation program?
5. Has the contractor validated its critical computer and PLC systems?

Cross-ContaminationRisks
1. How is the space utilized in the company? Is there adequate storage andmanufacturing space?
2. Are there specific areas for holding unapproved and rejected material?
3. Is there a locator system for storing and retrieving material?
4. How is the printed packaging material stored? Is it segregated appropriately withlimited access?
5. Are there cleaning procedures? Are they validated?
6. Are there line-clearance procedures?
7. Does the contractor stage or manufacture one lot at a time?
8. Are there cleaning and clearance logs for major equipment and lines?
9. Are the equipment and the lines properly identified as to their cleaning status?
10. Are the walls, ceilings and floors clean and free from potential contaminationhazards?
11. Are the hoses cleaned and stored properly?
12. Are the clean equipment and utensils stored covered in a clean area?
13. Are there any dedicated equipment or utensils? Are they appropriately coded oridentified?
14. Is there a sanitization program? Do they use appropriate cleaning agents thatremove product or microbiological residues?
15. Is the employees’ dress properly designed and is the dress code observed indesignated areas?
16. Are employee practices conducive to contamination prevention?

DocumentationPractices and Control
1. Does the contractor have a Master Documentation system?
2. Does the contractor have all the appropriate procedures for all the criticalfunctions?
3. Are the procedures up to date and consistent with cGMPs?
4. Are the procedures controlled, such that only one version is officially availableat all workstations?
5. Are any informal instructions printed and used?
6. Are the forms controlled?
7. Does each procedure have a revision history?
8. Does the contractor inform the customer of any critical changes in the procedures?
9. Are the appropriate individuals or departments involved in developing, approvingexecuting and training for all the procedures?
10. How are the obsolete procedures managed?

ChangeControl
1. Does the contractor have a formal change control procedure?
2. How are changes reported and implemented?
3. Are the changes documented?
4. Are the customers involved in reviewing and approving changes?
5. Does the supplier maintain a log of all change controls?
6. Who has the overall responsibility for managing the change controls? Is the Qualityunit involved?
7. Is the Regulatory department involved in reviewing changes that impact theFDA-filed status of the product?
8. Are all the personnel trained in reporting all changes?
9. Are all the changes consistent with the cGMPs?
10. How do they manage customer-initiated changes?

Warehousingand Distribution
1. Does the contractor have adequate warehousing space to hold all the material?
2. Are all the material and locations adequately identified?
3. Is the warehouse free from clutter?
4. Is the storage space for environmentally sensitive (e.g., light, temperature,humidity) material adequately controlled?
5. Are those areas monitored and mapped where applicable?
6. Are the ceilings, walls and floors free from debris?
7. Are the pallets and material neatly stacked? Are they free from debris?
8. Do they have an adequate pest control program for the site, including thewarehouse?
9. How are unidentified materials managed?
10. Is the Quality unit involved in any material damage event?
11.What is the policy on usage of containers and pallets? If reusable, is there acleaning program?

The Audit Kick-off Meeting
When you arrive at the contractor’s site, your first orderof business should to get your hosts comfortable. An auditor can achieve thisby pleasantly and professionally setting the right tone for the next couple of days, letting themknow that you are not on a mission to find faults but to work with them inidentifying any compliance or quality issues. You should discuss the standardsthat will be used and ask for any questions that they may have.

Next, you should explain the agenda and the role of each of member of your auditteam. Find out if agenda items must be shifted because of the contractor’sschedule. You should make sure to thank the contractor for finding the time andresources it is providing you and assure that the audit team will try to be asunobtrusive as possible.

The Audit Process
The Tour: One of the most important aspects of the audit isthe plant tour. A typical tour starts with the receiving area and progressesall the way thorough the final release and testing. You may choose to breakdown the tour in different segments and, if necessary, you can break up youraudit team to follow the pertinent contractor personnel. It may not benecessary for every member of your team to visit every area, but the leadauditor may choose to do it all.

Asking Questions: Do’s and Don’ts: Ask a lot of open-ended questions. Makesure not to jump the gun in making qualitative statements about the responses.One of the best ways is to repeat answers in a paraphrase, to better verifyunderstanding. Ask for specific examples, such as a document or a log, toverify the answer. Don’tinterrupt when someone is answering. Don’t nod unless you understandwhat is being said, but offer a smile to facilitate a positive answer.

When speaking, keep your tone low, but speak clearly. Don’tinflect words with cynicism or frustration. You must never lose your temper! Ifyou strongly disagree, just take a step back and make notes. Say somethinglike, "I’ll need to revisit this issue later and verify my understandingof the standard." Always refer to a known standard where possible.

Making Observations: When making observations that areverified by some evidence such as a document or a process, do so gently. Say,for example, that you believe that such a practice is not consistent withcGMPs, a known standard, or your contractor’s documented procedure. Make notes and let yourcontractor know that it will be included in your report. Don’t argue or haggleif the contractor disagrees; quickly go on to the next topic.

Verifying Observations: When verifying, look for stronglydocumented evidence. For example, if the contractor’s procedure requires thatan equipment cleaning process is documented immediately after it is cleaned,look for a specific entry that verifies this practice. Try to get thecontractor to understand your evidence and always provide an opportunity toexplain any discrepancies. Don’tmake statements based on superficial observations. You are not there tonit-pick, but rather to make systematic observations. Don’t document anyunverified observations.

Classifying Observations
Typically there are three types of observations: critical,major and minor. A critical observation must be strong enough to be correctedimmediately. An example would be lack of temperature monitoring for a stabilitychamber. A critical observation will most likely have impact on marketedproducts. You must inform your own management immediately about any criticalobservations after they are verified.

A major observation is reserved for an unacceptable practicethat may have an impact but is not as significant as a critical observation. Aminor observation is about a practice that has no significant impact on theproduct quality or its compliance status. However, if you have several minorobservations, they may reflect a major or a critical underlying systematicproblem.

Establishing Perspective
As youmake each observation, do not rush to classify them immediately, unless theyare glaringly obvious. Typically, your audit team should discuss theseduring breaks or lunch, to get a regulatory perspective. It may be necessary tohave a conference call with your senior management to get their perspective,but don’t call them for each and every observation.

HandlingDisagreements: As an auditor, you need not welcome disagreements;however, you must assure that your contractor understands your particularobservation. If the contractor disagrees, the auditor must try hard to definewhat the disagreement is about. Many times, the contractor may have a point. Attimes, the contractor may not be clear on what you are referring to. You musttactfully weed out the emotional aspects of the argument and relate yourselfand your contractor toward the standard. It may very well be that yourobservation is an exception. If so, allow your contractor to demonstrate that assertion.If you decide to make such an observation, you must balance it by noting thatit was an exception rather than the rule.

ManagingTime and Maintaining Focus: Time is a critical resource for you and yourcontractor. You can use it wisely, with proper planning and placing finite timebrackets around your audit areas. Unless an observation is critical or major,you need not hold court at your contractor’s site. If a particular observationtakes excessive time, don’t hesitate to note that clearly and politely, thenmove onto the next topic.

Don’tplan a long lunch and avoid having dinners with the contractors, if youplan to have your audit team meetings that night. If you decide to attenddinner with your contractor, don’t discuss the audit items during dinner. Ifyou are asked about an audit issue, politely decline to comment and offer todiscuss it on the next working day. An audit is supposed to be a focuseddisciplined process conducted in a professional forum at your contractor’ssite. Comments made during dinner may be easily misconstrued or forgotten. Planat least an hour a day to discuss your observations confidentially with youraudit team. Keep your phone calls to the "outside world" to aminimum.

DailySummaries
It is generally a good idea to recap a day’s work with yourcontractor. This is the time to summarize the day’s findings, confirm yourrequests for the next day and get an understanding of your contractor’sposition. Again, don’t use this time to specifically discuss any particular observationin detail, unless it is critical. This is typically a verbal session, so youneed not give anything in writing to your contractor unless specificallyrequested.

Audit Closure Meeting
It is very critical for your entire audit team and the contractor’ssenior management to attend the audit closure meetings. Typically, the auditteam should meet and have all the observations tabulated and agreed to beforethe closure meeting. It is appropriate for the lead auditor to start thismeeting by thanking all the contractor’s personnel for their help andhospitality during this audit. The audit team must set the tone in reiteratingthat the audit is meant as a tool to monitor your company’s quality andcompliance systems and not as an all-inclusive survey of all areas. If there are any positive thingsto be said about the plant or their systems, they should be said beforediscussing the observations. Remember: tactfulness is key. Allow yourcontractor to save face. Think of those problems in terms of opportunities.

Lastly, you should let the contractor know that yourobservations may be corrected if it turns out that you misunderstood any of itsprocesses. But your main objective is to say what you think, clearly andprofessionally.

If there are agreements about your observations, you may askyour contractor to provide a tentative corrective action plan and a timeline.Don’t get the contractor to commit to a rigid schedule unless there is acritical observation on the list.

If there is a disagreement, you should say that you beg todiffer and that you would be willing to take the contractor’s objections toyour management and let them know about the outcome. Don’t engage in longarguments. Let the contractor know about your report format and schedule and assurethem that there will be no surprises in the report.

The Audit Report
The Audit Report must mirror your audit closure meeting.Some auditors write up their audit report in a plaintext format before theclosure meeting and use that to discuss the observations at the meeting.

The audit report language should be professional and dealwith the facts. It should not contain any unsubstantiated opinions or anydisagreements. It should include a classification for each of yourobservations.

Where there are multiple observations relating to one system, it is better tocategorize them under one heading: e.g., Documentation System orValidation Program, rather than make several individual observations.

Follow-ups
No audit is really complete unless you receive a responsefrom your contractor and your company follows up on all the corrective actionitems. If the corrective action suggested by your contractor is not adequate,you must schedule a meeting of senior management and get their agreement to analternative plan. This meeting should be followed by a teleconference with yourcontractor to discuss your position.

It is not wrong to ask contractors for detailed descriptionsof what to expect from their corrective action plan. The auditor must be opento their suggestions, since they are sometimes the process experts. You neednot push for a pet solution, if the team agrees to the contractor’s plan.

Once the corrective action plan is agreed to, you may chooseto send periodic letters requesting the status of the plan. However, lettersshould be reserved to discuss critical and major items only, so as not todilute their impact.
An audit program can be a powerful tool in managing acontractor’s quality and compliance systems. However as with any tool, it is onlyas good as its user. A poorly managed audit program will result in a waste ofresources at both ends and may possibly ruin relationships between a sponsorand its contractors.

If used effectively however, an audit program offersfollowing benefits:

• It provides your company with a comprehensive index ofcompliance and quality problems with your contractors.
• It facilitates a perpetual corrective action program foryou and your contractor to address those problems.
• It creates a forum for planning newer and more effectivequality systems to prevent such problems from occurring.
• It fosters a forward-focused team environment and improvesrelationships between the two companies.

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